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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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
purity not reported
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-57-2
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-253
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Storage condition of test material: no data
- Other: specific gravity=1.203ml/ml

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, pennsylvania
- Age at study initiation: adult
- Weight at study initiation: 2.190-2.675 kg
- Fasting period before study: no
- Housing: individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory
Resources, National Research Council
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light


IN-LIFE DATES: From: 1985-08-29 To:1985-09-12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk (clipped free of fur)
- % coverage: min.10%
- Type of wrap if used: rubber dam and an ace bandage


REMOVAL OF TEST SUBSTANCE: no washing



TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Ten ( 5 females and 5 males)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 2h and 4h after the 24 h of exposure and twice daily for 14 days. Weighing: d0, d7 and d14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not applicable.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Mortality:
None of the animals died during the 14 days study.
Clinical signs:
Slight erythema: 10/10 animals, at 2 , 4 hours and Day 2 after the 24 hour period of exposure.
On Day 3, all animals appeared normal.
Body weight:
body weight increases normally
Gross pathology:
No signs observed

Applicant's summary and conclusion

Conclusions:
Based upon the observations made in the Acute Dermal Toxicity Test in Rabbits, the estimated acute dermal LD50 for the test substance was determined to be greater than 2000 mg/kg bw.