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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975-02-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is considered to be a reliability 2 study since it predates GLP but is similar to OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-cyclohexylethyl butyrate
EC Number:
264-158-4
EC Name:
1-cyclohexylethyl butyrate
Cas Number:
63449-88-7
Molecular formula:
C12H22O2
IUPAC Name:
1-cyclohexylethyl butanoate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males 219 g and females 220 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
3980, 5010, 6310, 7940, and 10000 mg/kg bw
No. of animals per sex per dose:
5 animals per dose. 2 or 3 males or females per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, gross autopsy was performed.
- Body weights: Individual body weights were recorded before treatment.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 300 mg/kg bw
Based on:
test mat.
95% CL:
>= 7 390 - <= 9 296
Mortality:
3980 mg/kg: 0/2 males and 1/3 females
5010 mg/kg: 0/3 males and 1/2 females
6310 mg/kg: 1/2 males and 1/3 females
7940 mg/kg: 2/3 males and 0/2 females
10000 mg/kg: 1/2 males and 3/3 females
Animals died within one to three days.
Clinical signs:
Reduced appetite and activity (one to two days in survivors), increasing weakness, collapse, and death.
Gross pathology:
Lung hyperemia, liver discoloration, and acute gastrointestinal inflammation. In the survivors (14-days) the viscera appeared normal.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
according to the CLP Regulation EC 1272/2008
Conclusions:
The acute oral toxicity test showed a LD50 of 8300 mg/kg bw
Executive summary:

In the study which predated GLP and OECD guidelines, a single oral administration of 3980, 5010, 6310, 7940, and 10000 mg/kg test substance to a group of 5 rats (2 or 3 males and 2 or 3 females) was investigated for 14 days. Reduced appetite and activity (one to two days in survivors), increasing weakness, collapse, and mortaility were observed. At necropsy lung hyperemia, liver discoloration, and acute gastrointestinal inflammation were observed in the different dose groups. In the survivors (14-days) the viscera appeared normal. In the 3980, 5010, 6310, 7940, and 10000 mg/kg dose group, 1/5, 1/5, 2/5 2/5, and 4/5 animals died within one to three days, respectively. Under the conditions of the test the oral acute LD50 in rats was determined to be 8300 mg/kg (95% Confidence limits 7390 - 9296 mg/kg bw)

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