Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes

Test animals

Species:
other: Rat (Sprague Dawley)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 1% methylcellulose in water
Duration of exposure:
24 h

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 animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
There was no systemic response to the treatment in any anima
l.
Gross pathology:
Effects on organs:
No abnormalities were noted in any animal at the microscopic
examination at study termination.
Other findings:
Signs of toxicity (local):
There were no deaths but 2 males showed a very slight dermal
irritation.

On day 8, a low bodyweight was recorded for 2 females and a
bodyweight loss was recorded for 1 other female.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU