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 data, no GLP, TS purity not specified;
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellyl acetate
EC Number:
205-775-0
EC Name:
Citronellyl acetate
Cas Number:
150-84-5
Molecular formula:
C12H22O2
IUPAC Name:
3,7-dimethyloct-6-en-1-yl acetate
Test material form:
not specified
Details on test material:
- Lot/batch No.: RIFM-70-462
No further details provided

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 – 3.1 kg
- Observation period before study: 7 d
- Housing: individually in hanging rabbit cages
- Food and water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 24 h before the dermal applications: an area on the backs of the animals was shaved (ca. 30% of total body surface), animals were returned to the cages to allow the stratum corneum to recover
- Type of wrap: impervious plastic secured with tape

TEST MATERIAL
- Concentration (if solution): undiluted test material
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, initial and final body weight, behavioral abnormalities, skin reactions

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
0/4 deaths
Clinical signs:
no effects; no behavioral abnormalities
Body weight:
No evident effect observed
Gross pathology:
no gross findings at necropsy
Other findings:
Local skin reactions:
after 24 h: irritant effects - definite red erythema, mild edema
after 6 d: superficial escharosis
end of the 14-day observation period: sloughing

Applicant's summary and conclusion