Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
guinea pig
Strain:
other: Bor: DHPW (SPF)
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
olive oil
Duration of exposure:
6 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females and 5 males at 2000 mg/kg (plus 2 additional reserve animals for each sex).
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
No abnormal findings for systemic toxicity.
No abnormal finding for local irritation.
Gross pathology:
No abnormal findings in organs observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in guinea pigs was found to be > 2000 mg/kg bodyweight. In 5 female and 5 male animals tested at 2000 mg/kg bodyweight there was no mortality observed and no clinical signs of systemic toxicity.