2-(4-methylcyclohex-3-en-1-yl)propan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 May to 9 June 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP study conducted according to OECD guideline with minor deviation: no certificate of analysis

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No certificate of analysis

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-menth-1-en-8-ol

EC Number:

233-986-8

EC Name:

p-menth-1-en-8-ol

Cas Number:

10482-56-1

Molecular formula:

C10H18O

IUPAC Name:

α,α-4-trimethyl-(1S)-3-cyclohexene-1-methanol

Constituent 2

Reference substance name:

(R)-α,α,4-trimethylcyclohex-3-ene-1-methanol

EC Number:

232-081-5

EC Name:

(R)-α,α,4-trimethylcyclohex-3-ene-1-methanol

Cas Number:

7785-53-7

Molecular formula:

C10H18O

IUPAC Name:

α,α-4-trimethyl-(1R)-3-cyclohexene-1-methanol

Constituent 3

Reference substance name:

1-methyl-4-(1-methylethylidene)cyclohexan-1-ol

EC Number:

209-584-3

EC Name:

1-methyl-4-(1-methylethylidene)cyclohexan-1-ol

Cas Number:

586-81-2

Molecular formula:

C10H18O

IUPAC Name:

1-methyl-4-(1-methylethylidene)-cyclohexanol

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Sprague-Dawley OFA

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO, l'Arbresle, France
- Age at study initiation: about 6 weeks
- Weight at study initiation: 196-207 g for males; 174-171 g for females
- Fasting period before study: overnight
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): UAR A04-10, Epinay sur Orge, France
- Acclimation period: at least 5 days
- Housed according to directive 86/609/EEC

IN-LIFE DATES: From: 26 May 1998 To: 9 June 1998

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations at least once a day, bodyweights recorded just prior to dosing and at days 4, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Preliminary study:

No data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female was found dead at day 2.

Clinical signs:

other: Piloerection and a decrease in motor activity and in muscular tonus were observed in all animals for the first 6 h after dosing. All effects were reversed at day 3.

Gross pathology:

In the female found dead, congestions in the lungs, liver, spleen and kidneys were observed. Stomach and intestines were bloated by gas. In the other animals, no particular finding was identified.

Other findings:

No data

Any other information on results incl. tables

Table 1: individual bodyweights in males and females

	Individual bodyweights (g) in males				Weight gain Day 1-Day 15
Animal number	Day 1	Day 4	Day 8	Day 15
9325	198.7	219.7	269.9	319.9	121.2
9326	196.0	196.7	240.7	288.7	92.7
9327	206.4	243.3	286.2	338.0	131.6
9328	198.2	221.6	266.6	307.2	109.0
9329	203.6	239.4	286.5	330.9	127.3
Mean ± SD	200.6 ± 4.3	224.1 ± 18.6	270.0 ± 18.7	316.9 ± 19.6	116.4 ± 15.7
	Individual bodyweights (g) in females				Weight gain Day 1-Day 15
Animal number	Day 1	Day 4	Day 8	Day 15
9330	180.9	197.7	214.5	243.3	62.4
9331	174.3	-	-	-	-
9332	174.7	195.9	219.8	246.2	71.5
9333	175.7	202.3	222.5	250.0	74.3
9334	175.7	196.5	226.8	245.7	70.0
Mean ± SD	176.3 ± 2.7	198.1 ± 2.9	220.9 ± 5.1	246.3 ± 2.8	69.6 ± 5.1

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of the test substance is higher than 2000 mg/kg bw for males and females. According to CLP regulation (EC) No 1272/2008, the test substance should not be classified.

Executive summary:

Acute oral toxicity study (limit test) with test substance Terpineol multiconstituent was conducted in 10 Sprague-Dawley OFA rats (5 males and 5 females) following OECD guideline 401. The test substance was administered undiluted through oral gavage at the single dose of 2000 mg/kg bw. Animals were observed for clinical signs at least once a day for 14 days. Body weights were taken just before dosing and at days 4, 8 and 15.

Piloerection and a decrease in motor activity and in muscular tonus were observed in all animals for the first 6 h after dosing. All effects were reversed at day 3 except for one female, found dead at day 2. In this female, congestions in the lungs, liver, spleen and kidneys were observed. Stomach and intestines were bloated by gas. In the other animals, no particular finding was identified at necropsy. Bodyweight increase throughout the study was normal.

The oral LD50 of the test substance is higher than 2000 mg/kg bw for males and females. Therefore, according to CLP regulation (EC) No 1272/2008, the test substance should not be classified.