1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone

Endpoint summary

Description of key information

Acute oral toxicity study: LD₅₀ greater than 15000 mg/kg bw (discriminating dose) (OECD 401, K, Rel.2)

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:

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:

The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal 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 were removed. The time of death of the deceased animals was documented.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Designation: Macrolex Green G
Physical state: solid
Appearance: green powder

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Experimental Animais
The acute toxicity experiment was carried out with young-adult SPF-bred female Wistar rats (Strain TNO/W70 (SPF Cpb).
The rat is the preferred species for investigating acute oral toxicity in mammals. At the start of the experiment, the rats were about 8 weeks of age.
The average initial weight of the female animals was 130 g. 10 rats were used per dose.

Housing Conditions
The rats were housed in groups of 5 under conventional conditions in Makrolon® Type-III cages on low-dust wood granules at a room temperature of 22 ± 2 °C, with humidity of about 50 ± 10%.

Nutrition
The animals received standard diet and tap water a libitum.

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal gavage on a constant application volume of 30 ml/kg body weight.

Doses:

10000 or 15000 mg/kg bw.

No. of animals per sex per dose:

10 female animals/dose.

Control animals:

no

Details on study design:

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 an dead animals were removed. The time of death of the deceased animals was documented. The animals were weighed individually directly before administration and groupwise after one week and at the end of the observation.

Key result

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

15 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the 14-day observation period.

Clinical signs:

other: other: After single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication.

Gross pathology:

Not examined.

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

A single dose of 10000 or 15000 mg/kg bw of the test substance was applied to 10 female Wistar rats each per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period. After the single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication. No animals died during the 14-day observation period. The LD50 was 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:

Equivalent or similar to OECD guideline 401.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

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). 

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