Tosylchloramide sodium

Endpoint summary

Description of key information

Acute toxicity oral (OECD TG 401): 381.6 mg/kg bw

Acute toxicity dermal (OECD TG 402): not applicable (corrosive to skin)

Acute toxicity inhalation (OECD TG 403) : not applicable (corrosive to skin)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January 1985 - 14 February 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was performed according to standard guideline and under GLP. Other test subtance was used.

Qualifier:

according to guideline

Guideline:

other: U.S. Environmental Protection Agency (EPA Publication 54019-82-025)

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

other: Hsd: (Sd) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley Inc, Houston Texas, USA
- Age at study initiation: young adult
- Weight at study initiation: males : 288 – 310 gram; female: 216 – 259 gram
- Fasting period before study: at least sixteen hours prior to treatment
- Housing: Cage Type: suspended wire bottom stainless steel. Housing: 1 - 3 per cage. Transfer to Clean Cages: Weekly. Litter Pan Lining: Paper and aspen bedding. Litter Pan Lining Change: Three times weekly.
- Diet (e.g. ad libitum): ad libitum, Purina Formulab Chow #5008
- Water (e.g. ad libitum): ad libitum, automatic
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: 31 January 1985 - 14 February 1985

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 8.00% w/v
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

8% w/v, this corresponds to and LD50 > 381.6 mg/kg for Chloramine-T.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and pharmacologic and/or toxicologic effects were made at least three times on the day of treatment and at least once daily thereafter for fourteen days (day of treatment considered Day 0). Individual body weights were recorded just prior to treatment and on Days 8 and 14.
- Necropsy of survivors performed: yes; A gross necropsy examination was conducted on each animal at termination of the study.
- Other examinations performed: none

Statistics:

no data

Preliminary study:

Not applicable

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 381.6 mg/kg bw

Remarks on result:

other: The acute oral LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 5010 mg/kg (4.77 ml/kg) when administered as a 8.00% w/v concentration in deionized water to albino rats. This corresponds to and LD50 > 381.6 mg/kg for Chloramine-T.

Mortality:

No mortality.

Clinical signs:

other: Prominent in-life observations included activity decrease, constricted pupils, piloerection, dilated pupils, and sensitivity to touch.

Gross pathology:

No effects observed

Interpretation of results:

other: Acute Tox. category 4

Remarks:

according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)

Conclusions:

The acute oral LD50 for actual KETJENSEPT TC as indicated by the data is greater than 5010 mg/kg (4.77 ml/kg) when administered as a 8.00% w/v concentration in deionized water to albino rats. This corresponds to and LD50 > 381.6 mg/kg for Tosylchloramide sodium.

Executive summary:

An acute oral toxicity study was conducted on male and female albino rats using test material KETJENSEPT TC 500 gram (hereafter referred to as KETJENSEPT TC). This study was designed and performed in STILLMEADOW, Inc.'s AAALAC accredited laboratory under Pesticide Assessment Guidelines promulgated by the U.S. Environmental Protection Agency (EPA Publication 54019-82-025) and was in compliance with Good Laboratory Practice Standards (Fed. Reg. 48, 53946, 1983). The test material was administered as an 8.00% w/v concentration in deionized water. Five males and five females were dosed at a level of 5010 mg/kg (4.77 ml/kg). No animals died during the study. The acute oral LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 5010 mg/kg (4.77 ml/kg) when administered as a 8.00% w/v concentration in deionized water to albino rats. This corresponds to and LD50 > 381.6 mg/kg for Tosylchloramide sodium.

The substance is classified as Acute oral toxic Cat 4 (H302) according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study is perfomed pre-GLP. It is not reported in the study how the animals were treated (acclimation period) before the study commenced, which or when clinical observations were made, what the exact bodyweights of the animals were before and after the study, what organs were examined when necropsy was performed or at what time necropsy was performed. Otherwise the method used is comparable to OECD 401. Therefore the study is deemed reliably with restrictions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Method: In house method of IBR, Hannover, Germany. It is not reported in the study how the animals were treated (acclimation period) before the study commenced, which or when clinical observations were made, what the exact bodyweights of the animals were before and after the study, what organs were examined when necropsy was performed or at what time necropsy was performed.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Hagemann
- Age at study initiation: no data
- Weight at study initiation: mean 250 g
- Fasting period before study: no data
- Housing: in individual cages
- Diet (e.g. ad libitum): ad libitum, received standard rat food (Plange)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10%
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: the test substance dissolves in distilled water
- Lot/batch no. (if required): not applicable
- Purity: not applicable

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

600, 756, 953, 1220 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: none

Statistics:

The LD50 was calculated according to Litchfield and Wilcoxon

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

935 mg/kg bw

95% CL:

>= 710 - <= 1 210

Mortality:

Mortality was observed at all test concentrations
Time of death: first observation after 3 hours
Number of deaths at each dose: 3 (2 within 24 hours and 1 on the second day), 3 (1 within 24 hours, on the second day and third day) , 4 (3 within 24 hours and 1 on the second day), 7  (within 24 hours) dead animals at 600, 756, 953, 1200 mg/kg bw, respectively

Clinical signs:

other: 600 mg/kg: All animals were slightly to moderately apatic after dosing. Two rats died within 24 hours, and a third after 40 hours. 756 mg/kg: All animals became strongly apatic and showed shallow respiration with increased rate. One animal died in 3 hours

Gross pathology:

Gross necropsy of deceased animals revealed stomach and intestinal hemorrhage, especially in fundus and pylorus of the stomach, and in duodenum and jejunum.

Interpretation of results:

other: Acute Tox. category 4

Remarks:

according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)

Conclusions:

The LD50 Tosylchloramide sodium, trihydrate in rats is 935 (CI 710-1210) mg/kg bw.

Executive summary:

A study was conducted on Wistar rats to determine the acute oral LD50. The dosage was administered by stomach probe. Mortality and gross necropsy examination was conducted at termination of study after 14 days. The study was not performed according to standardized guidelines, but methods were comparable to OECD 401 guideline.  A dose dependent increase in mortality was observed (600 mg/kg bw = 3 deaths, 756 mg/kg bw = 3 deaths, 953 mg/kg bw = 4 deaths and 1200 mg/kg bw = 7 deaths). Gross necropsy of deceased animals revealed stomach and intestinal hemorrhage, especially in fundus and pylorus of the stomach, and in duodenum and jejunum. Considering the corrosive properties of Tosylchloramide sodium, trihydrate these findings were expected.

The LD50 Tosylchloramide sodium, trihydrate in rats is 935 (CI 710-1210) mg/kg bw. The substance is classified as Acute oral toxicity category 4 (H302 Harmful if swallowed) according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

381.6 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October 1978 - 14 November 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study is performed pre-GLP and method is comparable to OECD 403. Method is well described but reporting of results is done with little detail. No necropsy was performed. Bodyweight of the animals are not recorded. Responses of individual animals are not shown. Since test substance preparation and animal exposure are described in detail the study is considered valid with restrictions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

The study was performed according to an in-house method from TNO (Zeist, The Netherlands) this method was comparable to OECD403.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist , The Netherlands.
- Age at study initiation: no data
- Weight at study initiation: males 182g and females 140g
- Fasting period before study: none, during the study period the animals did not have access to food.
- Housing: The animals were exposed in a stainless steel exposure chamber with a capacity of 1.5 m3. In the exposure chamber the animals were individually housed in wire-screen cages. They could continuously be observed through the hard glass entrance door of the chamber. During the 14-day observation period the animals were housed in stainless steel cages which were suspended in an open rack.
- Diet (e.g. ad libitum): ad libitum, institute's stock diet for rats.
- Water (e.g. ad libitum): ad libitum, bottled unfluorinated water
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 40-50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: 31 October 1978 To: 14 November 1978

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel exposure chamber
- Exposure chamber volume: 1.5 m3
- Method of holding animals in test chamber: wire-screen cages.
- Source and rate of air: air flow rate of 0.84 m3/h.
- Method of conditioning air: no data
- System of generating particulates/aerosols: "Wright" Dust Feed Mechanism
- Method of particle size determination: Particle size determinations and counts were carried out in samples taken from the atmosphere in the chamber with a Cascade impactor.
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data

TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of the dispersed Chloramine T was determined gravimetrically by passing a measured amount of the test atmosphere through a glassfibre filter.
- Samples taken from breathing zone: no

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Particle size determinations in impaction samples revealed a maximum particle diameter of 6.7 µm. Eighty percent of the dispersion consisted of particles with a diameter of 0.8-4.7 µm.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

continuously at a max. conc. of 275 mg/m3 air

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data

Statistics:

no data

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 275 mg/m³ air

Exp. duration:

4 h

Mortality:

no mortality

Clinical signs:

other: During the first 30 minutes of the exposure period the rats were slightly restless. The restlessness gradually disappeared and after one hour all rats were quiet.

Body weight:

no data

Gross pathology:

no data

Interpretation of results:

study cannot be used for classification

Conclusions:

It was concluded that the 4-hour LC50 of Chloramine T was higher than 275 mg/m3 air. This was the maximum attainable concentration in air. Therefore Chloramine T is not classified for acute inhalation toxicity.

Executive summary:

The acute inhalation toxicity of Chloramine T was studied by exposing rats for 4-hours to a dust dispersion of the substance in air at a concentration of 275 mg/m3 air. This was the maximum attainable concentration in air. No mortality occurred and no signs of intoxication were observed. It was concluded that the 4-hour LC50 of Chloramine T was higher than 275 mg/m3 air.

Reference 2

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test was perfomed pre-GLP. The test method is comparable to OECD 403. But reporting is done with little detail; No details on animals or test substance. Bodyweight of the animals are not recorded. Responses or authopsy of individual animals are not shown. Time of effect occurrence and duration of effects are not reported. No information on frequency of observations/clinical examinations. Since test substance preparation and animal exposure are described in detail the study is considered valid with restrictions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

The study was performed according to an in-house method from TNO (Zeist, The Netherlands) this method was comparable to OECD403.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Species:

rat

Strain:

other: not defined

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: young adults
- Weight at study initiation: males 250g and females 160g
- Fasting period before study: no data, no food available during exposure
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other:

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: no data
- Exposure chamber volume: 1.5m3
- Method of holding animals in test chamber: no data
- Source and rate of air: The aerosol was mixed with a supplementary air flow end continuously blown into an exposure chamber. The total flow rate thus obtained was 6m3/h.
- Method of conditioning air: no data
- System of generating particulates/aerosols: Just before administration a 5 % aqueous solution of the substance was prepared. This solution was dispersed by an aerodynamic nozzle nebulizer, provided with a glass bulb-shaped trap which removes the coarser droplets, operating at an air pressure of 1.5 kg/cm2 and producing an aerosol flow of 40dm3/min.
- Method of particle size determination: The concentration of the Halamid aerosol was determined gravimetrically by applying filters, through which samples were drawn. Microscopic impaction observations indicated a droplet seize range of 1 - 20 µ
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data,

TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of the Halamid aerosol was determined gravimetrically by applying filters, through which samples were drawn.
- Samples taken from breathing zone: no

VEHICLE
- Composition of vehicle (if applicable): water
- Concentration of test material in vehicle (if applicable): 5%
- Justification of choice of vehicle: no data
- Lot/batch no. (if required): not applicable
- Purity: not applicable

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Microscopic impaction observations indicated a droplet seize range of 1 - 20 µ
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5% aqueous solution in air

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

none

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4.15 mg/m³ air

Exp. duration:

4 h

Mortality:

no mortality

Clinical signs:

other: all animals showed a slight dyspnoea and kept their eyes closed

Body weight:

no data

Gross pathology:

no effects observed

Other findings:

none

Interpretation of results:

study cannot be used for classification

Conclusions:

It was concluded that the 4 hr LC50 of Halamid, dispersed as a 5% aqueous solution is more than 4.15 mg Halamid/dm3. None of the animals in this experiment died.

Executive summary:

The acute inhalation toxicity of a dispersed aqueous solution of Halamid was studied in albino rats. The study was performed pre-GLP and according to a TNO in-house method. None of the animals died.

It was concluded that the 4 hr LC50 of Halamid, dispersed as a 5% aqueous solution is more than 4.15 mg Halamid/dm3.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

22 January 1985 - 5 February 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study was performed under GLP but not according to standardized guidelines. Methods were comparable to OECD 402 guideline.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Method: other: Pesticide Assessment Guidelines, EPA , 540/9-82-025

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas
- Age at study initiation: young adult
- Weight at study initiation: 2.825 - 3.550 kilogram
- Fasting period before study: No, not applicable
- Housing:
Cage Type: Suspended wire bottom galvanized steel
Housing: Individually
Transfer to Clean Cages: Weekly
Litter Pan Lining: Paper
Litter Pan Lining Change: Daily
- Diet (e.g. ad libitum): ad libitum, Food: Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum, Water Type: Tap
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 22 January 1985 - 5 February 1985

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: ≥ 10%
- Type of wrap if used: Surgical gauze (two layers thick) was applied to the trunk of the animal and held in place with a non-irritating adhesive tape to keep the test matzrial in contact with the skin of the exposure area. The entire trunk of each animal was then wrapped with a semi-permeable material (Tomac Tubular Stockinette). The semi-permeable wrappings were secured in place with a non-irritating adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The wrappings, tape, and gauze were removed from the animals and the exposure areas were gently washed with room temperature tap water to remove as much remaining test material as possible.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.92 ml/kg
- Concentration (if solution): 8% w/v
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

Duration of exposure:

24 hours

Doses:

2020 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for pharmacologic and/or toxicologic effects and mortality were made at 1/2, 3, and 6 hours after treatment and at least once daily thereafter for fourteen days (day of treatment considered Day 0). Individual body weights were recorded on Days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: -

Statistics:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 020 mg/kg bw

Remarks on result:

other: calculated back to the active ingredient the LD50 is > 153.6 mg/kg bw

Mortality:

No mortality observed after 24 hours of exposure.

Clinical signs:

other: Decreased activity, decreased defecation, and no urination.

Gross pathology:

No abnormalities observed. 

Interpretation of results:

study cannot be used for classification

Conclusions:

The acute dermal LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 2020 mg/kg (1.92 ml/kg) when applied as a 8.00% w/v concentration in deionized water to the intact skin of albino rabbits. Calculated back to the pure test material the LD50 for the active ingredient is > 153.6 mg/kg bw . Therefore this study is not suitable for classification purposes but does give an indication of the LD50.

Executive summary:

An acute dermal toxicity study was conducted on male and female albino rabbits using test material KETJENSEPT TC 500 gram (hereafter referred to as KETJENSEPT TC). The test material was administered as a 8.00% w/v concentration in deionized water. This study was designed and performed in STILLMEADOW, Inc.'s AAALAC accredited laboratory under Pesticide Assessment Guidelines promulgated by the U.S. Environmental Protection Agency (EPA Publication 540/9-82-025) and was in compliance with Good Laboratory Practice Standards (Fed. Reg. 48, 53946, 1983).

Five male and five female albino rabbits were selected for testing. The exposure areas were treated with 2020 mg/kg of test material (1.92 ml/kg of a 8.00% w/v concentration of the test material in deionized water) and were then occluded for twenty-four hours. No animals treated with KETJENSEPT TC died during the study. The acute dermal LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 2020 mg/kg (1.92 ml/kg) when applied as a 8.00% w/v concentration in deionized water to the intact skin of albino rabbits. Calculated back to the pure test material the LD50 for the active ingredient is > 153.6 mg/kg bw .

Therefore this study is not suitable for classification purposes but does give an indication of the LD50.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Additional information

Acute toxicity oral

(Sabol, 1985) An acute oral toxicity study was conducted on male and female albino rats using test material KETJENSEPT TC 500 gram (hereafter referred to as KETJENSEPT TC). This study was designed and performed in STILLMEADOW, Inc.'s AAALAC accredited laboratory under Pesticide Assessment Guidelines promulgated by the U.S. Environmental Protection Agency (EPA Publication 54019-82-025) and was in compliance with Good Laboratory Practice Standards (Fed. Reg. 48, 53946, 1983). The test material was administered as an 8.00% w/v concentration in deionized water. Five males and five females were dosed at a level of 5010 mg/kg (4.77 ml/kg). No animals died during the study. The acute oral LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 5010 mg/kg (4.77 ml/kg) when administered as a 8.00% w/v concentration in deionized water to albino rats. This corresponds to and LD50 > 381.6 mg/kg for Chloramine-T. The substance is classified as Acute oral toxic Cat 4 (H302) according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

(Sterner 1967, rat) A study was conducted on Wistar rats to determine the acute oral LD50. The dosage was administered by stomach probe. Mortality and gross necropsy examination was conducted at termination of study after 14 days. The study was not performed according to standardized guidelines, but methods were comparable to OECD 401 guideline.  A dose dependent increase in mortality was observed (600 mg/kg bw = 3 deaths, 756 mg/kg bw = 3 deaths, 953 mg/kg bw = 4 deaths and 1200 mg/kg bw = 7 deaths). Gross necropsy of deceased animals revealed stomach and intestinal hemorrhage, especially in fundus and pylorus of the stomach, and in duodenum and jejunum. Considering the corrosive properties of Chloramine-T trihydrate these findings were expected. The LD50 Chloramine-T trihydrate in rats is 935 (CI 710-1210) mg/kg bw.

The substance is classified as Acute oral toxic Cat 4 (H302) according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

(Sterner, 1967, mice) The study was not performed according to standardized guidelines, but according to an in-house method of IBR. Used methods were comparable to OECD 401 guideline. The study was performed pre-GLP. The study was conducted on NMRI mice to determine the acute oral LD50. The dosage was administered by stomach probe. Mortality and gross necropsy examination was conducted at termination of study after 14 days.

Statistical method: Litchfield & Wilcoxon. A dose dependent increase in mortality was observed (755 mg/kg bw = 2 deaths, 952 mg/kg bw = 3 deaths, 1200 mg/kg bw = 5 deaths and 1512 mg/kg bw = 9 deaths). The LD50 is 1100 (CI 900-1330) mg/kg bw. Gross necropsy of deceased animals revealed stomach and intestinal hemorrhage. Considering the corrosive properties of Chloramine-T trihydrate these findings are expected. The LD50 Chloramine-T trihydrate in mice is 1100 (CI 900-1330) mg/kg bw.

Acute toxicity Inhalation and dermal

No classification is assigned for acute demal toxicity or acute inhalation toxicity as the substance is classifed as corrosive to skin.

Justification for classification or non-classification

Based on the available information, Tosylchloramide sodium is classified for acute oral toxicity (Cat. 4 / H302 Harmful if swallowed), according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

No classification is assigned for acute demal toxicity or acute inhalation toxicity as the substance is classifed as corrosive to skin.