Registration Dossier

Administrative data

Description of key information

In an acute oral toxicity study the test substance was applied as a single dose of 2500 mg/kg bw to 10 male Wistar rats per gavage. The animals were inspected for mortality and signs of intoxication during the following 14-day observation period. A dose of 2500 mg/kg body weight was tolerated without signs of poisoning by all animals. The discriminating dose was 2500 mg/kg bw.

No acute inhalation or dermal toxicity studies are available.

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘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’.  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.

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:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
10 male rats received a single dose of Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR in lutrol by gavage. The rats were observed during 14 days for clinical signs and mortality.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR
Species:
rat
Strain:
Wistar
Sex:
male
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
2500 mg/kg bw.
No. of animals per sex per dose:
10 male rats/dose
Control animals:
no
Statistics:
Probit-Analysis (Fink und Hund, Arzneimittelforsch. 15, 624 (1965)
Key result
Sex:
male
Dose descriptor:
discriminating dose
Effect level:
2 500 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died.
Clinical signs:
No signs
Body weight:
No data
Gross pathology:
No data

Based on technical reasons, the highest applied dose was 2500 mg/kg bw.

Interpretation of results:
GHS criteria not met
Conclusions:
None of the animals died. The discriminating dose was 2500 mg/kg bw (rat, male).
Executive summary:

A single dose of 2500 mg/kg bw of the test substance was applied to 10 male Wistar rats per gavage. The animals were inspected fpor mortality and signs of intoxication during the following 14-day observation period. A dose of 2500 mg/kg body weight was tolerated without signs of poisoning by all animals. The discriminating dose was 2500 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 500 mg/kg bw
Quality of whole database:
Scientifically acceptable and well documented.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In an acute oral toxicity study the discriminating dose for male rats was 2500 mg/kg body weight.

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘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’. 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.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified for acute oral and dermal toxicity.