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Toxicological information

Acute Toxicity: dermal

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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- State of aggregation: liquid

Test animals

Species:
other: rat, Tif:RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Switzerland
- Age at study initiation: Young adult initial age 7 to 8 weeks
- Weight at study initiation: 211 to 235 g
- Housing: individually housed
- Diet (e.g. ad libitum): Rat chow (NAFAG 890 Tox, NAFAG,Gossau, Switzerland) was provided ad libitum.
- Water (e.g. ad libitum): water was provided ad libitum
- Acclimation period: for at least 5 days before exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: at least 10% of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleaned with lukewarm water

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg body weight
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed twice on working days and once on weekend days. Signs and symptoms were noticed daily. Body weight was observed immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes, at the end of the observation period.
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No signs of specific toxicity.
Mortality:
No mortality occurred in this study.
Clinical signs:
Piloerection, abnormal body positions, and dyspnea were seen,
being common symptoms in acute dermal tests.
The animals recovered within 5 days.
Body weight:
The mean body weights of the animals were in the normal range throughout the study period.
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met