Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
not specified
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Sample Marking 77-170, Ethyl Pentyl Ketone
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 77-170, Ethyl Pentyl Ketone

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000mg/kg bw

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Other examinations performed: clinical signs

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:
None
Clinical signs:
Skin irritation was noted: Redness; mild (6/10), moderate (4/10). Edema; mild (1/10), moderate (9/10)
Other findings:
Kidney white nodules 1/10
Intestines, portions yellow 2/10
Liver, white nodules 1/10
Liver dark nodules 2/10
Exucate, anogenital 1/10

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Annex I of the CLP Regulation (1272/2008/EC)
Conclusions:
Based on the results in this study the testing material does not need to be classified for acute dermal toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

10 Rabbits were treated by dermal exposure to Ethyl Amyl Ketone at a dose level of 5000 mg/kg bw. Mortality and clinical signs were recorded. Signs of skin irritation (redness and oedema) were noted in all animals. There were no signs of systemic toxicity, none of the animals died. Necropsy of the animals after termination of the study revealed Kidney white nodules in 1/10 animals, yellow intestines portions in 2/10 animals, white nodules in the liver in 1/10 and dark nodules in 2/10, and anogenital exudate in in 1/10 animal. The LD50 for acute toxicity dermal was determined to be >5000 mg/kg bw. Based on these results the testing material does not need to be classified for dermal toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).