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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 7 days observation period, no body weight determination, limited information on effects observed
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Description: Clear liquid (Super saturated)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 100 - 160 g
- Fasting period before study: overnight

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Doses:
464, 1000, 2150, 4640, 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: Observations for mortality and signs of effects were made immediately after dosing at one, four, and 24 hours, and once daily thereafter
- Necropsy of survivors performed: yes
Statistics:
Mortality data was analyzed statistically, utilizing the tables of Horn H.J., Biometrics 12, 311, 1956

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
10 000 mg/kg bw
Based on:
test mat.
Mortality:
464 mg/kg bw: None
1000 mg/kg bw: One animal died 3 days after treatment
2150 mg/kg bw: None
4640 mg/kg bw: None
10000 mg/kg bw: One animal died 5 days after treatment and another 7 days after treatment.
Clinical signs:
464 mg/kg bw: Within 2 hours of treatment, 3 animals exhibited depression and piloerection, but within 24 hours of treatment all animals appeared normal
1000 mg/kg bw: All animals exhibited depression and piloerection within 2 hours of treatment, 3 of whom displayed a red hooding effect 24 hours after dosing. This effect is attributable to a lack of normal preening behavior.
2150 mg/kg bw: None
4640 mg/kg bw: None
10000 mg/kg bw: None
Gross pathology:
Within the two lowest dosage groups (464 and 1000 mg/kg bw) and particularly in the 1000 mg/kg bw level, yellow coloration was noted in the intestines. One animal in the 464 mg/kg bw dosage group exhibited this coloration, and 4 in the 1000 mg/kg bw level. All other animals in the study exhibited to notable necropsy findings, except those expected in the normal autolysis of animals found dead.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met