2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

Endpoint summary

Description of key information

The acute oral toxicity was determined in a study equivalent to OECD guideline 401. The LD50, rats oral was determined to be: 493 mg/kg bw (recalculated based on dye content of registered substance versus tested material).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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:

Only basic data given, equivalent to OECD guideline, no GLP study, the test substance was tested in a different composition as compared to the composition of the registered substance.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 197 g, female: 164 g
- Diet: Herilan MRH-Haltung, Alleinfutter für die Haltung von Mäusen, Ratten und Hamstern, Heinrich EGGERSMANN KG, Rinteln

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

VEHICLE
- Amount of vehicle: 0.5 % CMC in distilled water

Doses:

316, 464, 681, 1000, 1470, 2150 and 3160 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 150 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 493 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: recalculated based on dye content of registered substance (ca. 56% w/w) versus tested material (24% w/w)

Mortality:

681 mg/kg: 2 of 10 animals died
1000 mg/kg: 2 of 10 animals died
1470 mg/kg: 9 of 10 animals died
2150 mg/kg: 10 of 10 animals died
3160 mg/kg: 10 of 10 animals died

Clinical signs:

other: Death and poor general state on the 1st day of the study; nonspecific signs; at the highest dose, narcotic-Iike state with absence of pain and corneal reflexes.

Gross pathology:

Animals that died:
Heart: Acute dilatation and acute passive hyperemia
Intestines: Slightly diarrheal contents
Urine: Slightly colored

Sacrificed animals:
Organs: No abnormalities

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

493 mg/kg bw

Quality of whole database:

Comparable to guideline study with acceptable restrictions

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Only basic data given, equivalent to guideline, no GLP study, the test substance was tested in a different composition as compared to the composition of the registered substance.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 249 g, females 200 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C

Route of administration:

inhalation

Details on inhalation exposure:

Administration: Inhalation of an atmosphere enriched with volatile components at 20 °C. For enrichment 200 L air/h was flown through a 5cm layer of the product.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

mean concentration: 14.78 mg/L

No. of animals per sex per dose:

12 animals (sex unspecified)

Control animals:

no

Details on study design:

- method according to HF. Smith and Carpenter: J. Ind. Hyg. Tox. 26, 269 (1944)
- Frequency of observations: after 3 min, after 10 min, after 1 h, after 2 h, after 4 h and after 7 h
- Weighing: At the beginning and at the end of the test

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 14.78 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

7 h

Mortality:

no animals died

Clinical signs:

other: Slight irritation to the mucosa

Gross pathology:

Organs: No abnormalities detected.

Interpretation of results:

study cannot be used for classification

Remarks:

The acid content in this study is lower than the acid content of the composition of the registered substance. Therefore the results from these studies are not representative for the assessment of this endpoint. The study is only included in the dossier for the sake of completeness.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Only basic data given, equivalent to guideline, no GLP study, the test substance was tested in a different composition as compared to the composition of the registered substance.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

According to column 2 (section 8.5) of REACH Regulation Annex VII the studies for acute toxicity can be waived as the test item causes severe skin burns and is classified as skin corrosive, cat. 1B according to Regulation (EC) No 1272/2008.

Because of this classification and because of animal welfare reasons no new studies have to be conducted. Already existing studies with the test item are available. The test item was tested in different compositions. Composition 1 contains 24 % active substance and 20 % acetic acid.

Acute oral toxicity

Weight of evidence

BASF SE 1978 (Report No. 77/126)

A study equivalent to OECD guideline 401 was carried out by giving the test item (CAS 71598-17-9) to 5 male and 5 female rats per dose. The test item (CAS 71598-17-9) was given in a mixture containing 24 % of the active substance and 20 % acetic acid. The composition was administered orally in a solution of distilled water and carboxymethyl cellulose at doses of 316, 464, 681, 1000, 1470, 2150 and 3160 mg/kg bw. The post-treatment observation period was 14 days. The following results were obtained:

Death and poor general state on the 1st day of the study; nonspecific signs; at the highest dose, narcotic-Iike state with absence of pain and corneal reflexes.

The body weight examination revealed no major changes.

Heart: Acute dilatation and acute passive hyperemia

Intestines: Slightly diarrheal contents

Urine: Slightly colored

Organs: No abnormalities

Mortality was observed at 681 mg/kg bw onwards. The LD50 was determined to be ca. 1150 mg/kg bw. With regard to the actual test item composition the median lethal dose was recalculated to ca. 493 mg/kg body weight based on the active ingredient.

Acute inhalation toxicity

BASF SE 1978 (Report No. 77/126)

In a guideline study equivalent to OECD guideline 403, 12 rats (sex unspecified) were used in a method described by HF. Smith and Carpenter: J. Ind. Hyg. Tox. 26, 269 (1944) to test the acute inhalation toxicity. The test item (CAS 71598-17-9) was a preparation containing 24 % active substance and 20 % acetic acid. The animals were exposed by inhalation of an atmosphere enriched with volatile components at 20 °C. After an exposure time of 7 h the animals showed slight irritation to the mucosa. The LC50 was determined to be > 14.78 mg/L air.

Acute toxicity: Other routes (intraperitoneal)

BASF SE 1978 (Report No. 77/126)

In a neither guideline nor GLP compliant study 5 male and 5 female mice per dose were used. The test item (CAS 71598-17-9) was applied intraperitoneally in doses of 46.4, 68.1, 100 and 147 mg/kg bw in a mixture of 24 % of the active substance and 20 % acetic acid. Carboxymethyl cellulose was used as vehicle. The post-treatment observation period lasted 14 days. The animals exhibited the following results: The adipose tissue was slightly colored. Mortality occurred from 46.4 mg/kg bw onwards. The LC50 was determined to be ca. 80 mg/kg bw.

Justification for classification or non-classification

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results of the acute oral toxicity the substance is classified as acute oral toxicity cat. 4, H302: Harmful if swallowed for acute oral toxicity under Regulation (EC) No 1272/2008.