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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2012-09-11 to 2012-10-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 420 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP Compliance Monitoring Programme (inspected on 2012-07-10)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
cis-4-tert-butylcyclohexyl acetate
EC Number:
233-881-7
EC Name:
cis-4-tert-butylcyclohexyl acetate
Cas Number:
10411-92-4
Molecular formula:
C12H22O2
IUPAC Name:
4-tert-butylcyclohexyl acetate
Test material form:
liquid
Details on test material:
- Description: Clear colorless liquid
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS (RccHanTM:WIST)
- Source: Harlan Laboratories UK Ltd, Oxon UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 151-180 g
- Fasting period before study: overnight. Food will be returned approximately 3 to 4 hours after dosing.
- Housing: in group of up to four in suspended solid-floor polypropylene cages furnished with wooflakes.
- Diet (e.g. ad libitum): Rodent 2014C Teklad Global Certified Diet ad libitum. Not contaminated.
- Water (e.g. ad libitum): Tap water ad libitum. Not contaminated.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
For the purpose of the 2000 mg/kg bw dose level, the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 300 mg/kg bw dose level, the test item was freshly prepared, as required, as a solution in arachis oil BP
- Concentration in vehicle: 30 mg/mL
- Justification for choice of vehicle: the test item did not dissolve / suspend in distilled water.

DOSE VOLUME APPLIED:
- 300 mg/kg bw: 10 mL/ kg bw
- 2000 mg/kg bw: 0.932 mL/kg bw

- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300 mg/kg bw was chosen as the starting dose.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of mortality / morbidity inspection: twice daily, early and late, during normal working dates, once daily at weekends and public holidays. Due to a technical error, the Day 8 clinical observation for the initial animal treated at a dose level of 2000 mg/kg bw was not performed. This deviation was considered not to affect the purpose or integrity of the study as no signs of systemic toxicity were noted immediately before or after Day 8.
- Frequency of clinical observations: 30 min, 1, 2 and 4 hours after dosing, then at least once daily.
- Weighing: recorded on Day 0 (prior to dosing), Day 7 and 14, or at death.
- Necropsy of survivors performed: yes, gross necropsy on all animals. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
None

Results and discussion

Preliminary study:
In the absence of data regarding the toxicity of the test item, 300 mg/kg bw was chosen as the starting dose. In the absence of mortality or evident toxicity at a dose level of 300 mg/kg bw, an additional animal was treated at 2000 mg/kg bw. In the absence of mortality at a dose level of 2000 mg/kg bw, an additional group of animals was treated at 2000 mg/kg bw. A total of five animals were therefore treated at a dose level of 2000 mg/kg bw in the study Due to mortality at a dose level of 2000 mg/kg bw, an additional group of animals was treated at 300 mg/kg bw. A total of five animals were therefore treated at a dose level of 300 mg/kg bw in the study.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Two animals were found dead one or two days after dosing with 2000 mg/kg bw.
Clinical signs:
other: - 2000 mg/kg bw: Signs of systemic toxicity noted in animals were hunched posture, ataxia, lethargy and occasional body tremors. Surviving animals appeared normal two hours, one or two days after dosing. - 300 mg/kg bw: No signs of systemic toxicity were
Gross pathology:
Abnormalities noted at necropsy of the animals that died during the study were abnormally red lungs, dark liver, dark or pale kidneys and epithelial sloughing of the gastric mucosa and non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
300 mg/kg bw < Oral LD50 Females < 2000 mg kg bw.
Under the test conditions, the test item is classified as Acute oral tox. 4 (H302: Harmful if swallowed) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study performed according to the OECD test guideline No. 420 and in compliance with GLP, groups of fasted, eight to twelve weeks of age Wistar (RccHanTM:WIST) female rats were given a single oral dose of test item undiluted or as a suspension in Arachis oil BP. Following a sighting test at dose levels of 300 mg/kg bw and 2000 mg/kg bw, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg bw. Due to mortalities at a dose level of 2000 mg/kg bw, an additional group of four fasted females was given a single oral dose of test item, as a solution in arachis oil BP, at a dose level of 300 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Oral LD50 Females: in the range 300 - 2000 mg/kg bw.

Two animals treated at a dose level of 2000 mg/kg bw were found dead one or two days after dosing. There were no deaths at a dose level of 300 mg/kg bw. Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg bw were hunched posture, ataxia, lethargy and occasional body tremors. There were no signs of systemic toxicity at a dose level of 300 mg/kg bw. Surviving animals showed expected gains in bodyweight. Abnormalities noted at necropsy of the animals that died during the study were abnormally red lungs, dark liver, dark or pale kidneys and epithelial sloughing of the gastric mucosa and non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Under the test conditions, the test item is classified as Acute oral tox. 4 (H302: Harmful if swallowed) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.