Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

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 males and 6 females
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.

A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application.
Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.

A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.