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: Acceptable study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute dermal toxicity study
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Neryl acetate
- Lot/batch No.: 71-10-56, 1-13-72
- Physical state: clear liquid
no further data given

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Acclimation period: min. 14 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: back of animal
- Type of wrap if used: covered with a snuggly fitting rubber sleeve or dam
- Test substance applied to clipped intact and abraded skin areas

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (thorougly wiped down)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2/3.9/6 ml/kg bw
- Constant volume or concentration used: no
Duration of exposure:
24 h
Doses:
2, 3.9, 6 ml/kg bw (= 1820, 3549, 5460 mg/kg bw, based on a density of 0.91)
No. of animals per sex per dose:
4 animals/dose
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: appropriate tissues examined histopathologically in dead animals (no further data)
- Other examinations performed:
Food consumption,
Body weights,
General behavior;
Hematology (performed during acclimatization period and 14d post dose: red/white cell count, differential, grams hemoglobin, % hematocrit) Urinalysis (performed during acclimatization period and 14d post dose)

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 6 mL/kg bw
Remarks on result:
other: corresponds to 5460 mg/kg bw, based on a density of 0.91
Mortality:
0/12
Clinical signs:
no effects
Body weight:
no effects
Gross pathology:
no data
Other findings:
Hematology: no effects
Urinalysis: no data given

Any other information on results incl. tables

No erythema, edema observed. Animals consumed their daily ration, gained weight and behaved as normal laboratory acclimated animals. No significant changes in hematogram obseverved.

Applicant's summary and conclusion