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
Limit test:
yes

Test animals

Species:
other: Rat (Wistar)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
propylene glycol
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: 1
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
The body weight gain during the observation period was
within the expected range for rats used in this type of stud
y.
Gross pathology:
Effects on organs:
A clear watery fluid in the abdominal cavity was found in
the animal that was found dead. Macroscopic examination of
the other animals revealed pelvic dilation of the right
kidney (two males) This abnormality was considered to be
within hte background pathology of for rats of this age and
strain and was not considered to be of toxicological
significance. Females showed no macroscopic abnormalities.
Other findings:
Signs of toxicity (local):
One male was found dead on day 2 of treatment. No clinical
signs were shown by this animal. No further mortality
occurred.


General erythema, scales and/or scabs were noted on the
treated skin of all animals during the observation period.
Isolated cases of chromodacryorrhoea (ocular and nasal
"bleeding") were noted at the end of the observation period.

The surviving animals had recovered from the symptoms
between days 4 and 13 (except for chromodacryorrhoea).

Applicant's summary and conclusion

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