Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
Version / remarks:
before 2002
Deviations:
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:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5 g/kg
No. of animals per sex per dose:
10 animals
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
5/10
Clinical signs:
Piloerection, Lethargy, Ptosis, Flaccid
Body weight:
Not specified
Gross pathology:
Lungs dark 2/10
Kidneys mottled 2/10
- Left, white nodules 1/10
Intestines portions red 3/10
Stomach bloated 2/10

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 toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

10 Rats were treated by the oral exposure to Ethyl Amyl Ketone at a dose level of 5000 mg/kg bw. Mortality and clinical signs were recorded. Signs of systemic toxicity included piloerection, lethargy, ptosis and flaccidity. Five animals were found dead one day after dosing. Necropsy revealed damage to lungs, kidneys, intestines and stomach. The LD50 was determined to be 5000 mg/kg bw. Based on these results the testing material does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).