N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide

Endpoint summary

Description of key information

The substance is practically nontoxic; no adverse effects were noted in acute toxicity studies up to the highest dose level administered.

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:

17 Sep - 03 Oct 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 188.3 g +/- 10.8 g
- Housing: in transparent macrolon® cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70% r.h.
- Photoperiod (hrs dark / hrs light): 12/12 hours

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw (single dose)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The acute oral toxicity of Disperse Blue 291.1 was tested only at a dose level of 2000 mg/kg body weight (limit test) according to toxicity data of related compounds. The animals received the compound as a 20 % suspension in tylose, the administration volume
was 10 mL/kg body weight. If no compound-related mortality is produced in this limit test according to the guidelines no further dose has to be tested.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice per day (once per day during weekends)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured

Clinical signs:

other: 30 – 60 minutes hour after administration: uncoordinated gait, squatting posture and irregular respiration Urine was discolored red on day 1 and later on up to day 3 discolored dark as well as faeces.

Gross pathology:

No macroscopically visible changes observed

Interpretation of results:

GHS criteria not met

Conclusions:

The substance did not lead to any deaths. Only transient unspecific clinical signs of acute toxicity were seen after oral exposure (gavage) of 6 female rats. The LD50 > 2000 mg/kg bw. The substance is not classifiable according to GHS criteria.

Executive summary:

An acute oral toxicity study with Disperse Blue 291:1 was conducted in female rats according to OECD 423 at the limit dose levels of 2000 mg/kg body weight.

No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific clinical signs the animals showed impairments of motility and respiration starting 30 – 60 minutes after test substance administration. Additionally, urine was discoloured reddish on Day 1 and further on, urine and faeces were discoloured dark up to Day 3. From day 4 until the end of the study, no clinical signs were observed. One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals. All animals were killed at the end of the observation period and underwent necropsy. No macroscopically visible changes were observed during necropsy.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Jan 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Alderley Park, UK
Initial body weight: 150 - 200 g

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured

Clinical signs:

other: Day 1 and 2: yellow-stained urine and dark blue faeces

Gross pathology:

No abnormalities observed

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is >5000 mg/kg. The substance is not classifiable according to CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Key study is a GLP guideline study (OECD 423).

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Principles of method if other than guideline:

The test was conducted according to an internal procedure.

GLP compliance:

no

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

air

Remarks:

saturated with test item

Details on inhalation exposure:

Inhalation by means of inhalation of test substance saturated atmosphere for 8 h. To achieve saturation, air was fed through an approx. 5 cm deep layer of the test substance.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

8 h

Concentrations:

saturation concentration

No. of animals per sex per dose:

12 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations: daily observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy

Statistics:

NA

Preliminary study:

NA

Key result

Sex:

not specified

Dose descriptor:

LC0

Based on:

test mat.

Remarks:

40% purity

Exp. duration:

8 h

Remarks on result:

other: no effect at saturation concentration

Mortality:

no deaths

Clinical signs:

other: no effects

Body weight:

no data

Gross pathology:

no effects

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, no mortality was observed in the treated rats.

Executive summary:

A study was conducted to determine the acute inhalation toxicity of the test substance according to an internal procedure. A group of 12 rats were exposed for 8 h to the vapour of saturated test substance and thereby observed for 14 d. Under the study conditions, no mortality was observed in the treated rats (Munk, 1977).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Key study is a test in accordance with national standard methods.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

An acute oral toxicity study with Disperse Blue 291:1 was conducted in female rats according to OECD 423 at the limit dose levels of 2000 mg/kg body weight.

No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific clinical signs the animals showed impairments of motility and respiration starting 30 – 60 minutes after test substance administration on Day 1. Additionally, urine was discoloured reddish on Day 1 and further on, urine and faeces were discoloured dark up to Day 3. From day 4 until the end of the study, no clinical signs were observed. One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals. All animals were killed at the end of the observation period and underwent necropsy. No macroscopically visible changes were observed during necropsy.

A study was conducted with a structural analogue to determine the acute inhalation toxicity of the test substance according to an internal procedure. A group of 12 rats were exposed for 8 h to the vapour of saturated test substance and thereafter observed for 14 days. Under the study conditions, no mortality was observed in the treated rats.

Justification for classification or non-classification

Based on a category approach with two structural analogue substances, Disperse Blue 291.1 Br is not classifiable according to CLP criteria. All LD50s (oral, gavage) in rats were >2000 mg/kg bw.