1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone

Endpoint summary

Description of key information

Two valid acute oral toxicity studies are available for Reinblau BLW (CAS 32724-62-29

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:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and sufficient documented

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Five male and five female Wister rats reveived per gavage a single dose of 5 ml/kg Macrolex Blue RR liquid. The animals were observed for mortality, weight and clinical signs through day 14. A spot-check autopsy was performed on the animals killed at the end of the study.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5.0 ml/kg bw

No. of animals per sex per dose:

5 male and 5 female animals/dose

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Clinical signs:

other: other:

The dosage of 5 ml/kg applied once did not lead to systemic poisoning in any of the male and female animals. No deaths occurred. The body weight development was not influenced. Necropsy of some males and females killed at the end of the study did not reveal any remarkable finding.

Executive summary:

Five male and five female Wister rats reveived per gavage a single dose of 5.0 ml/kg Macrolex Blue RR liquid. The animals were observed for mortality, weight and clinical signs through day 14. A spot-check autopsy was performed on the animals killed at the end of the study.

The dosage of 5.0 ml/kg applied once did not lead to systemic poisoning in any of the male and female animals. No deaths occurred. The body weight development was not influenced. Necropsy of some males and females killed at the end of the study did not reveal any remarkable finding. LD50 for male and female rats was greater than 5.0 ml/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

15 000 mg/kg bw

Quality of whole database:

The materials/methods and results are described in detail und are sufficient for evaluation

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

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

Justification Document for the Category of Six Anthraquinone Dyes

LANXESS Deutschland GmbH has registered five mono-constituent anthraquinone dyes of similar chemical structure using a category approach: Solvent Violet 36 (CAS No 82-16-6), Solvent Green 3 (CAS No 128-80-3), Reinblau RLW (CAS No 41611-76-1), Reinblau BLW (CAS No 32724-62-2) and Solvent Green 28 (CAS No 4851-50-7). Additional data were taken from another registered anthraquinone dye, Solvent Blue 104 (CAS No 116-75-6), leading to a category consisting of six members (see attached justification in the Category dossier).

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other: other:

Clinical Signs

A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. Locally, a blue discoloration of the treatment area was observed.

The most plausible interpretation is a discoloration by the blue color of the test item (which is not considered a toxicologically relevant effect).

Body Weights

There were no toxicologically significant effects on body weight or body weight development in males and females.

Gross Pathology Findings

The necropsies performed at the end of the study revealed no particular findings.

Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semioclclusively for 24 hours.

None of the animals died. A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. There were no toxicologically significant effects on body weight or body weight development in males and females.

The necropsies performed at the end of the study revealed no particular findings.

LD50 > 2000 mg/kg bw (rat, male + female)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The materials/methods and results are described in detail und are sufficient for evaluation

Additional information

Two valid acute oral toxicity studies are available for Reinblau BLW. In the key study the test substance was formulated in peanat oil and was intragastrically administered at doses of 10 or 15 g/kg bw to 10 female animals each. The animals were observed for mortality, weight and clinical signs through day 14. None of the animals died. In the second study five male and five female Wistar rats reveived per gavage a single dose of 5 ml/kg Macrolex Blue RR liquid. The dosage of 5 ml/kg applied once did not lead to systemic poisoning in any of the male and female animals. No deaths occurred.

The results were supported by an acute oral toxicity study with Reinblau RLW (CAS 41611 -76 -1). Five male and five female Wister rats received per gavage a single dose of 5000 mg/kg bw Macrolex Blau CA 51056 (Reinblau RLW). The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed on animals killed after the observation period. A dose of 5000 mg/kg bw was tolerated without symptoms. The LD50 is > 5000 mg/kg bw for male and female rats.

No acute dermal toxicity study is available for Reinblau BLW. Due to the close structural sililarity (1,4-bis[(2,6-diethyl-4-methyl- phenyl)amino]anthraquinone (CAS-No. 32724-62-2) has an additional ethylgroup in the aromatic side chains in relation to with1,4-bis(2-ethyl-6-methy1anilino) anthraquinone (CAS-No. 41611-76-1), the similar physicochemical and toxicological properties a read-across between the 2 compounds is justified.

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item Reinblau RLW applied semioclclusively for 24 hours. None of the animals died. A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. The necropsies performed at the end of the study revealed no particular findings.

LD50 > 2000 mg/kg bw (rat, male + female)

Justification for selection of acute toxicity – oral endpoint
key study used

Justification for selection of acute toxicity – dermal endpoint
read-across from Reinblau RLW (CAS 41611-76-1)

Justification for classification or non-classification

Due to the results of the acute oral studies and the acute dermal study a classification is not justified.