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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:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only short abstract; insufficient for assessment to few data available
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Range finding toxicity data: list V
Author:
Smyth, H.F.; Carpenter, C.P.; Weil, C.S.; Pozzani, U.C.
Year:
1954
Bibliographic source:
Arch Ind. Occup. Med. 10, 61-68

Materials and methods

Principles of method if other than guideline:
Penetration of rabbit skin is estimated by technique cessentially the one-day cuff method of Draize et al. (1944) using groups of four rabbits.
GLP compliance:
no
Remarks:
test conducted before the development of GLP
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: New Zealand giant albino rabbits
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk (fur was closely clipped over the entire trunk
- % coverage: 1/10 of body surface
- Type of wrap if used: impervious plastic film

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 h contact, the film was removed



Duration of exposure:
24 h
Doses:
at least 20 mL/kg bw equivalent to 17600 mg/kg bw, calculated with a density of 0.88 g/cm³
No. of animals per sex per dose:
4 males; not clearly stated, if 4 males in total or 4 males per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 17 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculated on a density of 0.88 g/cm³

Applicant's summary and conclusion