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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:
other: Older publication: Some experimental details are missing, but basic data given. Low number of animals in study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Study from 1975 (no guidelines available at the time the study was performed).
Deviations:
not applicable
Principles of method if other than guideline:
Male albino rabbits (3 - 5 months of age) were immobilised during the 24 h contact period with the TS retained under impervious sheeting on the clipped intact skin of the trunk. Thereafter, excess fluid was removed to prevent ingestion. Maximum dosage that can be retained was 20 mL/kg.
Dosage levels differ by a factor of 2 in a geometric series. LD50 values were calculated by the moving average method based on a 14 day observation period.
GLP compliance:
no
Remarks:
Study from 1975 (GLP was not compulsory at the time the study was performed).
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch No.: 38-93

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
Male albino rabbits with an age of 3 - 5 months.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Dosed in fume hood under polyethylene sheeting.
Duration of exposure:
24 hrs
Doses:
8.0 or 16.0 mL/kg bw (ca. 7280 or 14560 mg/kg bw)
No. of animals per sex per dose:
8.0 mL: 2
16.0 mL: 7
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days.
Gross pathology.
Statistics:
No data.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 14 560 mg/kg bw
Mortality:
8.0 mL: No deaths.
16.0 mL: 3/7 animals died.
Clinical signs:
>= 8.0 mL: skin erythema.
16.0 mL: Hiccup-like spasms in 2 animals at 6 days. Skin leathery and scaly (probably from dehydration).
Body weight:
8.0 mL: -65, 135
16.0 mL: -13, -79, -147, -703
Gross pathology:
Spleens and kidneys congested in victims. Nothing remarkable in survivors.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
At a dose of 8.0 mL/kg bw no animals died while at 16.0 mL/kg bw 3/7 animals died.
Executive summary:

In this older study with limited documentation male albino rabbits (n = 2 - 7 per group) were dosed with 8 or 16.0 mL/kg bw.

From this study a LD50 of about 16.0 mL/kg bw (ca. 14560 mg/kg bw) can be derived (mortality 3/7 at this dose level).