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:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: (Crl : CD BR)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK
- Age at study initiation: approx. 8-12 weeks
- Weight at study initiation: 204 - 212 g (males), 206 - 222 g (females)
- Housing: individually during the 24 h exposure period and subsequently 5 animals of the same sex per cage in polypropylene cages on woodflakes
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 49-64
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a surgical gauze which was held in place with a piece of self-adhesive bandage. The bandage was further secured with a piece of BLENDERM wrapped around each end.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was wiped with cotton wool moistened with distilled water to remove residual test substance.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.05 mL/kg bw
- Constant concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2 and 4 h after administration and subsequently once daily for 14 days. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidente of primary irritation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No signs indicative for systemic toxicity were noted during the study.
Body weight:
All animals showed an expected gain in body weight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
No skin reactions were noted until the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the conducted study, a LD50 value > 2000 mg/kg bw was derived.