Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 September 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
EC Number: 948-020-7

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: External
- Age at study initiation: Young adult
- Fasting period before study:
- Housing: The rabbits were individually housed in wire mesh bottom cages in an environment controlled room
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: A minimum of 5 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Immediately after application, the trunk of each animal was wrapped with an occlusive binder that consisted of a layer of plastic wrap and a stockinette sleeve all secured in place with masking tape.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 per sex per dose
Details on study design:
At the end of 24 hours, the occlusive binders were removed and the exposure sites were gently wiped with clean gauze to remove as much non-·absorbed test article as possible. The animals were observed for mortality and toxic signs frequently on the day of dosing and twice daily thereafter for 14 days. The animals were weighed prior to initiation of the study and on days 8, 15 or at death.

All animals dying during the 14 day post-dose observation period and those sacrificed at the termination of the study were subjected to a gross necropsy and abnormalities were noted.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the 15 day post- dose observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the dermal LD50 of the test material has been determined for both sexes as greater than 2000 mg/kg bw.
Executive summary:

A study has been performed to determine the acute dermal toxicity of the test material. The study has been conducted under GLP conditions and to OECD guidelines. The study has been given a Klimisch Score of 1. The test material was evaluated for in male and female New Zealand White rabbits. The test material was applied to each of ten rabbits at a level of 2000 mg/kg body weight, followed byocclusive coverage for a 24 hour treatment period. Dressings were removed approximately 24 hours after application and excess test substance was removed. Morbidity, mortality, and clinical signs were recorded twice daily for 14 days. Body weights were recorded prior to initiation of the study and on days 8 and 15. Gross necropsies were performed. All animals survived the 15 day post- dose observation period.Under the conditions of the study, the dermal LD50of the test material has been determined for both sexes as greater than 2000 mg/kg bw. Thetest material is not considered to be toxic when applied dermally to New Zeal and White rabbits