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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:
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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
The individual growth weight of both males and females were normal. The mean weight gain in 14 days of treatment period was satisfactory (Table 1).
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 

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 

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.