Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No deaths or toxicologicall significant observations at 5000 mg/kg.

In a 14-day dose range finding toxicity study no mortality was observed up to and including 1000 mg/kg/day.

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
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
5 male and 5 female Wistar rats were dosed with a single oral gavage dose of 5000 mg/kg.
GLP compliance:
yes
Test type:
other: limit test with 5000 mg/kg
Limit test:
yes
Specific details on test material used for the study:
Evercion Red H-E 7B Dry Powder.
Seperate statement confirms that the test item is Reactive Red 141; CAS 71002-20-5.
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes
Statistics:
not applicable
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no mortality
Clinical signs:
other: no clinical signs
Gross pathology:
no observations
Other findings:
no effects reported
Interpretation of results:
GHS criteria not met
Executive summary:

No deaths or clinical signes reported.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
No deaths or toxicologicall significant observations at 5000 mg/kg. In a 14-day dose range finding toxicity study no mortality was observed up to and including 1000 mg/kg/day.

Additional information

Justification for classification or non-classification

No deaths or toxicologicall significant observations at 5000 mg/kg.