(2E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-05-26 to 1998-06-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study following OECD guideline 401 but there was no certificate of analysis, no details about test substance and environmental conditions for animals

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, no details about test substance and environmental conditions

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:

(2E)-2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol

EC Number:

701-122-3

Cas Number:

106185-75-5

Molecular formula:

C14H24O

IUPAC Name:

(2E)-2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol

Test material form:

liquid

Details on test material:

Name of test material : (2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol / 2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol
Molecular formula : C14H24O1
Smiles notation: OCC(=CCC(C(C(=C1)C)(C)C)C1)CC

Test animals

Species:

rat

Strain:

Sprague-Dawley

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 old
- Weight at study initiation: 188 - 210 g for males, 173 - 181 g for females
- Fasting period before study: overnight
- Housing: 5/sex in polypropylene cages
- Diet (e.g. ad libitum): pelleted diet (UAR A04-10, Epinay sur Orge, France ), ad libitum
- Acclimation period: at least 5 days

IN-LIFE DATES: From: 1998-05-26 To: 1998-06-09

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/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: observed daily for clinical signs; bodyweights recorded prior to the test material administration (D1), D4, D8 and D15
- Necropsy of survivors performed: yes

Statistics:

No data

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: Six hours following administration of the test substance, a slight piloerection was observed in all animals. 1 hour after administration, a decrease in motor activity and muscle tone was noticed in one male and one female.

Gross pathology:

There were no visible organic or tissular lesions 14 days after treatment.

Other findings:

No data

Any other information on results incl. tables

Table 1: BODY WEIGHT - Individual values (g)

Animal N°	D1	D4	D8	D15	D15 – D1
Sex : Male
9315	192.6	215.4	276.0	338.2	145.6
9316	192.8	207.3	263.7	323.0	130.2
9317	209.3	255.5	300.4	357.5	148.2
9318	188.9	224.1	268.6	329.7	140.8
9319	201.2	238.5	276.7	333.2	132.0
Mean	197.0	228.2	277.1	336.3	139.4
SD	8.2	19.2	14.1	13.1	8.0
Sex : Female
9320	178.1	206.6	226.0	247.7	69.6
9321	180.5	211.4	227.2	245.5	65.0
9322	176.0	195.3	214.3	234.0	58.0
9323	173.2	198.9	220.7	237.1	63.9
9324	178.9	199.8	220.9	247.9	69.0
Mean	177.3	202.4	221.8	242.4	65.1
SD	2.8	6.5	5.1	6.5	4.7

MACROSCOPIC EXAMINATION

Sex : Male

Animal N°	MORTALITY		OBSERVATIONS
	Day	Cause
9315	D15	Sacrifice	Normal
9316	D15	Sacrifice	Normal
9317	D15	Sacrifice	Normal
9318	D15	Sacrifice	Normal
9319	D15	Sacrifice	Normal
Sex : Female
Animal N°	MORTALITY		OBSERVATIONS
	Day	Cause
9320	D15	Sacrifice	Normal
9321	D15	Sacrifice	Normal
9322	D15	Sacrifice	Normal
9323	D15	Sacrifice	Normal
9324	D15	Sacrifice	Normal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 of the test substance is higher than 2000 mg/kg bw.
The substance is not classified according to directive 67/548/EEC and CLP regulation (EC) n° 1272/2008.

Executive summary:

An acute oral toxicity study (limit test) with the test item was conducted in 10 albino Sprague Dawley rats (5/sex/dose) under GLP conditions following OECD guideline 401. The test substance was administered through oral gavage at the single dose of 2000 mg/kg bw. Animals were observed daily for clinical signs and mortality for 14 days. Body weights were taken prior to the administration of the test material, D4, D8 and D15. Six hours following administration of the test substance, a slight piloerection was observed in all animals. 1 hour after administration, a decrease in motor activity and muscle tone was noticed in one male and one female. There was no mortality. All animals were subjected to necropsy at the end of the observation period. No gross lesions were found.

Therefore, oral LD50 of the test substance is higher than 2000 mg/kg bw. According to directive 67/548/EEC and CLP regulation (EC) n° 1272/2008, the test substance should not be classified.