3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate

Endpoint summary

Description of key information

In a GLP guideline study from 1990, the LD50 (oral, gavage) of the test substance in male/female rats was found to be >2000 mg/kg bw (corresponding to 960 mg/kg bw act. ingr.). 1/5 female rats died and had clinical symptoms and pathological findings. 4/5 female and 5/5 male rats survived without any findings. However, since the dye content was only 48% and the content of active ingredient too low to exclude a classification according to CLP criteria, a second study from 1974 (equivalent to guideline study) was taken into account for a weight-of-evidence approach: under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). Based on both results, the substance is not classifiable according to CLP criteria.

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:

weight of evidence

Study period:

Oct 1974

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)

Principles of method if other than guideline:

Male rats were administered the test substance by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.

GLP compliance:

not specified

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:

Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 150-200 g
Temperature and relative humidity: 22 +/- 1.5°C and 60 +/- 5%, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Dose volume applied: 20 mL/kg bw

Doses:

3000, 3500, 4000, 4500, 5000, 6300 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Statistics:

Probit analysis

Sex:

male

Dose descriptor:

LD50

Effect level:

4 068 mg/kg bw

Based on:

test mat.

95% CL:

> 3 735 - < 4 418

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 115 mg/kg bw

Based on:

act. ingr.

Mortality:

0/10 at 3000 mg/kg bw, 3/10 at 3500 mg/kg bw, 5/10 at 4000 mg/kg bw, 7/10 at 4500 mg/kg bw, 8/10 at 5000 mg/kg bw, 10/10 at 6300 mg/kg bw

Clinical signs:

Sedation, breathing difficulties, seizures

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). The substance is not classifiable according to CLP criteria.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

13 - 27 Feb 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

"Richtlinie 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S.93)"

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:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Breeder: Winckelmann, Borchen
Acclimatization period: at least 5 d
Age: 8-10 weeks old
Body weight: 174-192 g
Temperature and relative humidity: 22 +/- 2°C and 55 +/- 5%, respectively
Light period: 12h light/12h dark
Diet and water: Altromin 1324 and tap water, ad libitum
Fasting period before study: 16 - 4 h

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was diluted into water and administered at a constant rate (10 mL/kg bw) by gavage

Doses:

2000 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: pior to, 1 week after and 2 weeks after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

according to Spärman & Kärber

Sex:

male/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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 960 mg/kg bw

Based on:

act. ingr.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

Male: 0/5; female: 1/5 (on day 2)

Clinical signs:

Male: none; female: bad general condition, sedation, prone position in 1/5 animals (ca. 8 h after application)

Body weight:

No treatment related effects

Gross pathology:

Male: no effects; female: gastric mucosa elapsed and all organs in the abdominal cavity blue stained in 1/5 animals

Other findings:

None

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 (oral, gavage) of the test substance in male/female rats was found to be >2000 mg/kg bw (corresponding to 960 mg/kg bw act. ingr.). 1/5 female rats died and had clinical symptoms and pathological findings. 4/5 female and 5/5 male rats survived without any findings.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 115 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available