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Description of key information

Two valid acute oral toxicity studies are available for Reinblau BLW (CAS 32724-62-29
A valid acute oral and acute dermal toxicity study are available for Reinblau RLW (Reinblau 41611-76-1)

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented
Qualifier:
according to
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.

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:
discriminating dose
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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
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.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: RCCHan:WIST
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats per dose
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

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 Wister 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.