Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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: Non-GLP, slightly deviating from guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Principles of method if other than guideline:
Groups of three animals, except the high dose group of two animals, were exposed topically to one dermal dose of test substance. Animals were observed during a period of 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl hexanoate
EC Number:
204-642-4
EC Name:
Allyl hexanoate
Cas Number:
123-68-2
Molecular formula:
C9H16O2
IUPAC Name:
allyl hexanoate
Details on test material:
- Name of test material (as cited in study report): Allyl hexanoate
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported


Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not reported

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
Not reported
Doses:
0.313, 0.625, 1.25 and 5.0 g/kg bw
No. of animals per sex per dose:
3, except high dose: 2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: not reported
Statistics:
Not reported

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
820 mg/kg bw
Based on:
test mat.
95% CL:
700 - 940
Mortality:
In the low dose groups 313 and 625 mg/kg bw, no animal died during the observation period of 14 days. In the dose group of 1250 mg/kg bw, one animal died on day one and two animals died on day two following dermal exposure. In the high dose group of 5000 mg/kg bw, all animals died on day one following dermal exposure.
Clinical signs:
other: Diarrhea was obserwed in one animal at 625 and 1250 mg/kg bw dose groups, whereas at 5000 mg/kg bw dose group symptom was obserwed in two animals.
Gross pathology:
Not reported
Other findings:
In the dose group of 313 mg/kg bw, a moderate redness was obserwed in one animal, whereas moderate edema was obserwed in all three animals. In the dose group of 625 mg/kg bw, the both moderate redness and moderate edema were obserwed in all three animals. In the dose group of 1250 mg/kg bw, the both slight rednes and moderate redness were obserwed in one out of trhee animals, whereas slight edema was obserwed in two out of three animals.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was acutely toxic to rabbits in an acute dermal toxicity test with an LD50 value of 820 mg/kg bw. The substance is classified into Acute Toxicity Category III according to CLP.
Executive summary:

The acute dermal toxicity of the test substance allyl hexanoate was studied in a non-GLP test according to principles slightly deviating from those of current guidelines. Groups of three animals were exposed to single dermal doses of 0.313, 0.625 and 1.25 g/kg bw, whereas a group of 2 animals was exposed to single dermal dose of 5.0 g/kg bw. Animals were observed during a period of 14 days. No mortality was observed in 0.313 and 0.625 g/kg bw dose groups. In 1.25 and 5.0 g/kg bw dose groups, respectively three out of three and two out of two animals were died within the first days of the observation period. The LD50 value was 0.82 g/kg bw with a 95 % confidence interval of 0.70 to 0.94 g/kg bw. Diarrhea was observed in one animal dosed with 0.625 and 1.25 g/kg bw and in two out of two animals dosed with 5.0 g/kg bw. Slight to moderate skin irritation was observed in animals of 0.313 to 1.25 g/kg bw dose groups.

Categories Display