Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Direct Blue 267
IUPAC Name:
Direct Blue 267

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Duration of exposure:
24h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw, number of deaths: 0Female: 2000 mg/kg bw, number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: no deaths and no treatment related sign of toxicity
Gross pathology:
Effects on organs: no treatment related sign of toxicity

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
The analogue substance was tested for acute dermal toxicity following EU Method B3. Under the experimental conditions the LD50 > 2000 mg/kg bw.
Executive summary:

The analogue substance was tested for acute dermal toxicity following EU Method B3. Under the experimental conditions the LD50 > 2000 mg/kg bw