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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
February 23 - April 4, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted to meet GLP regulations, however, the test followed standard guideline procedures (US Federal Hazardous Substances Labeling Act (FHSLA) 16 CFR 1500).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Acute Dermal Toxicity: FHSLA 16 CFR 1500.
Deviations:
not specified
GLP compliance:
no
Test type:
other: Limit test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: as solution in light petroleum distillates
Details on test material:
A viscous brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
The animals were housed 1 per cage. Feed and water were provided ad-libitum after dosing.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The rabbits were prepared by clipping the skin of the trunk free of hair. Epidermal abrasions were made over a 5-6 cm2 area on 3 males and 2 females. The remaining five rabbits were not abraded. A non-permeable patch containing 2.0 ml/kg body weight of the test material was placed over a 4-5 cm2 area on all rabbits. The patches were secured in place with tape and an elastic sleeve. The rabbits were immobilized in head stocks for 24 hours at which time the patches were removed and the rabbits returned to their cages. Feed and water were provided ad-libitum. The rabbits were
observed for 14 days.
Duration of exposure:
24 hours
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 10 mg/kg bw
Based on:
act. ingr.
Mortality:
Skin Sex Body Weight Dose Mortality
Treatment kg grams Test Day

Abraded M 2.73 55 14
Abraded M 2.60 52
Unabraded M 2.37 47 2
Unabraded M 2.72 54
Unabraded M 2.62 52 4
Abraded F 2.71 54
Abraded F 2.97 59 5
Abraded F 3.0 60
Unabraded F 2.5 50 6
Unabraded F 2.41 48
Clinical signs:
Surviving rabbits exhibited anorexia, weight
loss, debilitation, spasticity.
Body weight:
See table.
Gross pathology:
Nos. 1M, 2M, 5M - I iver necroses, enlarged kidneys
Nos. 7F, 9F - 1 iver necroses, concentrated urine,
enlarged kidneys.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The Dermal LD50 of the test material is ~ 20 ml/kg for a 50% formulation. The LD50 as active ingredient is greater than 10,000 mg/kg.
Executive summary:

A dermal acute toxicity test was conducted in New Zealand Albino Rabbits. Ten rabbits (5 male / 5 female) received a dose of 20 ml/kg bw of the test substance for 24 hours and were observed for 14 days for signs of toxicity and mortality. The skin of 5 rabbits was abraded prior to dosing (5-6 cm2 area on 3 males and 2 females). The Dermal LD50 of the test material is ~ 20 ml/kg. The LD50 as active ingredient is greater than 10,000 mg/kg.