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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
10 rabbits were dermally administered a single dose of the test material and observed during 14 days.
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl enantate
EC Number:
203-382-9
EC Name:
Ethyl enantate
Cas Number:
106-30-9
Molecular formula:
C9H18O2
IUPAC Name:
ethyl heptanoate

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No details were provided.

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No details were provided.
Duration of exposure:
No details were provided.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals in total.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and mortality

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the study.
Clinical signs:
Clinical signs included diarrhea in 2/10 animals from days 11 - 14.
Skin irritation observed:
- mild redness in 6/10, moderate redness in 4/10
- mild edema in 3/10, moderate edema in 7/10
Gross pathology:
Necropsy findings included white nodules in the liver (4/10), bloated and venated large intestines (2/10), blood in the thoracic cavity (1/10), dark spots in parts of the liver (1/10), small white nodules and irregular nodes in the intestines (1/10), and mottled kidneys (2/10).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of the test item was > 5000 mg/kg bw.
Executive summary:

In the current study a group of 2 - 10 rabbits were dermally administered a single dose of the test material. No OECD guideline was followed and the study was not GLP.

After the treatment the animals were observed for mortality and clinical signs during 14 days. Furthermore, necrospy was conducted.

The acute dermal LD50 of the test item in rabbits was reported to be > 5000 mg/kg bw, based on 0/10 deaths at that dose.