Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

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)
Principles of method if other than guideline:
Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semioclclusively for 24 hours.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
not used for calculations (content > 95 %)

Test animals

Species:
rat
Strain:
other: RCCHan:WIST
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 male and 5 female rats per dose
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Clinical Signs

A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. Locally, a blue discoloration of the treatment area was observed.

The most plausible interpretation is a discoloration by the blue color of the test item (which is not considered a toxicologically relevant effect).

Body Weights

There were no toxicologically significant effects on body weight or body weight development in males and females.

Gross Pathology Findings

The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semioclclusively for 24 hours.

None of the animals died. A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. There were no toxicologically significant effects on body weight or body weight development in males and females.

The necropsies performed at the end of the study revealed no particular findings.

LD50 > 2000 mg/kg bw (rat, male + female)