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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 15, 1996 - August 29, 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.3 (Acute Toxicity (Dermal))
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: 7-10 weeks
- Weight at study initiation: 214-287 g
- Housing: individually 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: 28 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

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 mm x 50 mm (dorso-lumbar region). One day prior to treatment hair was removed with electric clippers.
- % coverage: 10% of the total body surface
- Type of wrap if used: the treated area was promptly covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After treatment, the treated area was washed with warm (30-40 ºC) water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.09 ml/kg bw
Duration of exposure:
24 hours.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 rats 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.
Macroscopic pathology: opening the abdominal and thoracic cavities, and macroscopic appearance of all organs.
- Others: Local dermal irritation at the treatment site was assessed daily by draize scoring method (erythema and oedema).

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:
There were no deaths.
Clinical signs:
There were no signs of systemic reaction to treatment.
Body weight:
A loss in bodyweight was recorded for one female rat on day 8.
Gross pathology:
No macroscopic abnormalities were observed at necropsy.
Other findings:
- Other observations: Slight irritation (grade 1 or 2 erythema/oedema) was evident in two female animals following removal of the dressing. This was fully resolved by the following day in one animal and by day 6 in the remaining animal.

Applicant's summary and conclusion

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

An acute dermal toxicity test was performed on 2 -methylcyclohexyl acetate in accordance with ECC method B.3. Five male and five female rats were given a single dermal application of 2000 mg/kg bw test item. Mortality, clinical signs, bodyweight and dermal responses were observed for 14 days after dosing. All animals surviving were killed on day 15 and macroscopic examinations were conducted. There were no deaths and no signs of systemic reactions to treatment. Slight irritation was evident in two female rats following removal, and were fully resolved by the following day and by day 6 respectively. A loss of body weight was only recorded for one female rat on day 8. No abnormalities were observed at the macroscopic examinations. One female rat died shortly after dosing (macroscopic examination revealed congestion of the stomach, duodenum and small intestine). Based on these result the acute dermal LD50 for 2 -methylcyclohexyl acetate was determined to be >2000 mg/kg bw in rats.

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