Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2000-05-17 to 2000-07-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol

EC Number:

947-711-0

Molecular formula:

C14H28O

IUPAC Name:

Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl : CD ® (SD) IGS BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males - 202 to 233 g; females - 209 to 226 g
- Fasting period before study: overnight fasting right before dosing
- Housing: in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum during the study
- Water: ad libitum during the study
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD
- Rationale for the selection of the starting dose: based on available information. The testing sequence followed the flow chart described in OECD 423.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- observations: at 30 min, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
-- weighing: prior to dosing and at 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination, examination of major organs

Statistics:

No statistical analysis was performed. The LD50 was determined from the nominal dosing level.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Diarrhoea was noted in two male animals during the day of dosing. No other adverse clinical signs were noted.

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

Bodyweight and bodyweight gain during the treatment and observation period

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) during Week
		0	7	14	1	2
2000	1-0 Female 1-2 Female 1-3 Female	216 226 209	246 264 240	262 285 261	30 38 31	16 21 21
	2-0 Male 2-1 Male 2-3 Male	222 233 202	286 299 255	325 367 385	64 66 53	39 68 30

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality was observed at dosing level 2000 mg/kg. The LD50 of the test item was determined to be >5000 mg/kg.

Executive summary:

A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Sprague-Dawley CD strain rat. The test was performed according to OECD 423 "Acute Oral Toxicity - Acute Toxic Class Method" (1996) and Commission Directive 96/54/EC Method B1 tris. 2000 mg/kg bodyweight was selected as the starting dose. A group of three fasted females was treated with the starting dose. This was followed by a group of three fasted males at the same dose level. The test item was administered orally, undiluted. The animals were observed 30 min, 1, 2 and 4 hours after dosing and then once daily for fourteen days. Bodyweights were recorded on the day of dosing and on Days 7 and 14. At the end of the observation period all animals were killed by cervical dislocation and subjected to gross necropsy. There were no deaths during the study. Diarrhoea was noted in two male animals during the day of dosing after 2 and 4 hours. No other adverse clinical signs were noted. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral LD50 of the test item in the Sprague-Dawley rat, was estimated as being greater than 5000 mg/kg bodyweight as no mortalities were noted in animals treated with 2000 mg/kg bodyweight.