Registration Dossier

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: Study meets generally accepted scientific principles (restriction: purity unknown; reliability adopted from OECD SIDS)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA, Nycum JS
Year:
1969
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 30: 470-476
Reference Type:
study report
Title:
Unnamed
Year:
1961

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Penetration of rabbit skin is estimated by a technique closely akin to the one-day, cuff Method of Draize.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Unknown purity

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 3-5 months
- Mean weight at study initiation: 2.5 kg


ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Groups of male New Zealand rabbits received n-propyl acetate, applied undiluted, to intact, nonabraded skin. Fur was clipped and removed from the entire trunk of each rabbit prior to application of the test substance. Four rabbits were included in each dose group. n-Propyl acetate was applied to the dorsal surface of the trunk and spread over as large an area as possible. The test material was retained on the skin beneath an impervious plastic film.
Rabbits were immobilized during the 24-hr contact interval. After treatment, all wrappings were removed.
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4 male animals/ treatment
Control animals:
not specified
Details on study design:
Animals were observed for signs of toxicity after dosing, and throughout the 14-day observaton interval. Animals that died on study were subjected to necropsy; animals sacrificed at the end of the observation interval were also necropsied.
Statistics:
Thompson's method of calculating the LD50 was applied to the 14-day mortality data.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 17 800 mg/kg bw
Remarks on result:
other: corresponding to 20 mL/kg (calculated with a density of 0.888 g/mL as preferred result in the OECD SIDS dossier)
Clinical signs:
Erythema and necrosis of the skin were observed.

Applicant's summary and conclusion