Cyclohexanepentanol, .beta.-methyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-04-07 to 2008-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

, adopted 2001-12-17

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2007-10-15

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol

EC Number:

700-146-1

Cas Number:

1141487-54-8

Molecular formula:

C12H24O

IUPAC Name:

(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 212 - 242 g
- Fasting period before study: an overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Housing: the animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (ad libitum, exception see "Fasting period before study" above): Certified Rat and Mouse diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Relative humidity: 30 to 70 %
- Air exchanges: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

SIGHTING STUDY / MAIN STUDY
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose. A single animal was treated as follows: dose level: 2000 mg/kg; specific gravity: 0.892; dose volume: 2.25 mL/kg. In the absence of mortality at a dose level of 2000 mg/kg, an additional group of four animals was treated as follows: dose level: 2000 mg/kg; specific gravity: 0.892; dose volume: 2.25 mL/kg. A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

MAXIMUM DOSE VOLUME APPLIED: 2.25 mL/kg

DOSAGE PREPARATION: the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.

Doses:

2000 mg/kg bw. (sighting study / main study)

No. of animals per sex per dose:

5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Preliminary study:

2000 mg/kg bw:
- no deaths were recorded.
- animal had diarrhoea during the day of dosing. No other signs of systemic toxicity were noted during the study.
- animal gained the expected gains in body weight over the observation period.
- no abnormalities were noted at necropsy

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Two animals had diarrhoea during the day of dosing. No other signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route, as well.