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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 16 to October 30, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Red RA 10463
IUPAC Name:
Red RA 10463

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:(WI) BR
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
corn oil
Duration of exposure:
24 hour exposure followed by 14 days observation period
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals
Control animals:
no
Details on study design:
- Observations: clinical signs (daily), mortality (daily), body weights (weekly), macroscopic examination (at necropsy)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in the study period.
Clinical signs:
other: Purple staining of skin/fur in various areas of all animals: snout, back, tail, abdomen, flank, chest. Staining persisted until termination in some cases. Staining of snout/neck occurred in one male and four females, of which persisted until termination i
Gross pathology:
No abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 (dermal, rat) > 2000 mg/kg bw
LD0 ≥ 2000 mg/kg bw