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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 30, 1996 - August 13, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylcyclohexyl acetate
EC Number:
227-231-1
EC Name:
2-methylcyclohexyl acetate
Cas Number:
5726-19-2
Molecular formula:
C9H16O2
IUPAC Name:
2-methylcyclohexyl acetate
Details on test material:
- Name of test material (as cited in study report): 2-Methyl cyclohexyl acetate
- Physical state: Liquid
- Analytical purity: >95%
- Lot/batch No.: 36586
- Storage condition of test material: Room temperature in the dark.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England.
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 90-103 g
- Fasting period before study: Food was only prevented overnight prior to and approximately 4 hours after dosing.
- Housing: Five rats per sex, in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): Ad libitum (SDS LAD 1).
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 ºC
- Humidity (%): Not controlled but anticipated in the range of 30-70%.
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (artificial light).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.1 ml/kg bw
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals per sex and per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: at least twice daily
Clinical signs: soon after dosing, every 4 hours during day 1, twice daily on subsequent days (with exception of day 15, morning only).
Body weight: day 1 (prior to dosing), day 8 and 15 or at death.
- Necropsy of survivors performed: yes, all animals surviving treatment were killed on day 15 by cervical dislocation.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic pathology: opening the cranial, abdominal and thoracic cavities, and macroscopic appearance of all tissues.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female rat died shortly after dosing.
Clinical signs:
Clinical signs prior to death were piloerection and increased salivation.
Piloerection persisted on day 1 and was accompanied by hunched posture, waddling gait, lethargy, decreased respiration, partially closed eyelids, pallor of extremities, unsteadiness, cold body surfaces, ungroomed appearance, walking on toes (males only), prostration and loss of righting reflex (one female). Recovery was complete by day 4.
Body weight:
No effects were observed.
Gross pathology:
Female rat dead shortly after dosing: Congestion of stomach (characterised by injected blood vessels), duodenum and small intestine. The stomach contained a clear liquid (assumed to be the test material).
Animals killed on day 15: No macroscopic abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for 2-methylcyclohexyl acetate was determined to be >2000 mg/kg bw in rats.
Executive summary:

An acute oral toxicity test was performed on 2 -methylcyclohexyl acetate in accordance with EEC method B.1. Five male and five female rats were exposed to 2000 mg/kg bw by gavage. Mortality, clinical signs and bodyweight were observed for 14 days after dosing. All animals surviving were killed on day 15 and macroscopic examinations were conducted. One female rat died shortly after dosing (macroscopic examination revealed congestion of the stomach, duodenum and small intestine). Clinical signs were observed but recovery was complete by day 4. No macroscopic abnormalities were observed for animals killed on day 15. Based on these result the acute oral LD50 for 2 -methylcyclohexyl acetate was determined to be >2000 mg/kg bw in rats.

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