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Administrative data

Description of key information

Acute toxicity, Oral (similar to OECD 401): LD50 5000mg/kg bw

Acute toxicity, Dermal (similar to OECD 402): LD50 >5000mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 77-170, Ethyl Pentyl Ketone
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5 g/kg
No. of animals per sex per dose:
10 animals
Control animals:
no
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
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).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
comparable to guideline study with acceptable restrictions

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 77-170, Ethyl Pentyl Ketone
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
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
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
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
comparable to guideline study with acceptable restrictions

Additional information

Oral

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).

Dermal

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).

Justification for classification or non-classification

Ethyl Amyl Ketone 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).