1,8-bis[(4-methylphenyl)amino]anthraquinone

Endpoint summary

Description of key information

Acute oral toxicity - LD50 > 15000 mg/kg bw (OECD 401, K, rel 2.)

 

In the acute oral toxicity study with Solvent Violet 36, the LD50 was greater than 15000 mg/kg bw (discriminating dose). There are no studies available for acute inhalation or dermal toxicity.

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation
period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application at the end of the 14-day observation period.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Purity: technically pure

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

The acute toxicity experiment was carried out with SPF-bred Wistar rats (strain Wistar TNO W 74). At the start of study the female rats were about 14 weeks old and females 14weeks.
The rats were housed in groups of five animals each under conventional conditions in Makrolon Type-III cages on dust-free wood granules; they were exposed to a room temperature of 22 ± 1.5° C, a 12-hour light/dark cycle (artificial light from 7 a.m. to 7 p.m. CET), and relative humidity of about 60 ± 5 %.
During the study period the animals received feed and tap water ad libitum.
The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application and at the end of the 14-day observation period.

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

The substance was formulated inpeanut oil and once administered to 10 female animals at a constant application volume of 30 ml/kg body weight. A rigid metal gavage was used for that purpose. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application and at the end of the 14-day observation period.

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

10 female rats/dose

Control animals:

no

Details on study design:

A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation
period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application at the end of the 14-day observation period.

Key result

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

15 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died.

Clinical signs:

other: other: The dose of 15000 mg/kg body eight, which was administered once, was tolerated without symptoms.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is greater than 15000 mg/kg bw (discriminating dose).

Executive summary:

A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period. The dose of 15000 mg/kg body weight, which was administered once, was tolerated without symptoms by all female animals. The LD50 is greater than 15000 mg/kg bw (discriminating dose).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

15 000 mg/kg bw

Quality of whole database:

study well documented, meets generally accepted scientific principles, acceptable for assessment.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to REACH Regulation (EC) No 1907/2006 Annex VIII, 8.5.3 Column 2:
Testing by the dermal route does not need to be conducted if:
— the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and
— no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).
The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

Clinical signs:

other: other:

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The acute oral toxicity is greater than 15000 mg/kg bw (discriminating dose). The acute dermal toxicity of the read-across substance is greater than 2000 mg/kg bw (discriminating dose).

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.