2-(2-(4-methyl-3-cyclohexen-1-yl)propyl)cyclopentanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 March 1989 to 11 September 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-

Molecular formula:

C14H24O1

IUPAC Name:

Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-

Constituent 2

Reference substance name:

Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-

Molecular formula:

C15H24O

IUPAC Name:

Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-

Constituent 3

Reference substance name:

Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-

Molecular formula:

C15H24O

IUPAC Name:

Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-

Constituent 4

Reference substance name:

Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-

Molecular formula:

C15H24O

IUPAC Name:

Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-

Test material form:

liquid

Specific details on test material used for the study:

Name (as stated in the report) : NECTARYL - LRG 1371
Identification for the study: 07683 D9 001
Description: colourless slightly viscous liquid
Batch No.: AS1241001

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source supplier: Iffa-Credo (69210 L'Arbresle - France)
- Age: young adults between 6 and 8 weeks old
- Weight at the start of treatment: from 209 g to 267 g (the weights for each sex varied by no more than 20 % of the mean the animals)
- Cages: housed individually in type FI polycarbonate cages (interior dimensions 305 x 180 x 184 mm)
- Air changes: at least 10 per hour
- Temperature: 21 to 27°c
- Humidity: 44 to 79 % R.H
- Lighting artificial, 12 hours out of 24 (photoperiod = 7h30 - 19h30)
- Hygiene: bedding changed once a week; cages changed for each study

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Remarks:

test substance as supplied

Details on dermal exposure:

The test substance was spread over an area of approximately 10 % of the total body surface area. It was applied uniformly using a finger covered by a very fine natural latex glove and to ensure penetration of all the substance or of the maximum possible quantity the area was lightly massaged for approximately 15 seconds.
The test substance was kept in contact with the skin by means a semi­ occlusive dressing composed of a perforated adhesive band (Peloplast) 10 cm wide, applied onto an elastic crepe bandage (Creplux / Molinier) covering the entire shaved area to avoid any possible orthoergic reactions and encircling the trunk of the animal without interfering with the abdominal and respiratory movements of the animal. This dressing entirely covered the treated area to avoid ingestion of the test substance by the animals.

Duration of exposure:

24 hour period

Doses:

2008 mg/kg

No. of animals per sex per dose:

A single dose was applied to a group of rats composed of 5 males and 5 females.

Control animals:

no

Details on study design:

Reason for the choice of the dose level : no deaths were seen at a dose level of 2008 mg/kg during the preliminary study.
Since the absence of mortality was confirmed after the 14 day observation period, no other dose level was applied and the study was considered completed.

Results and discussion

Preliminary study:

No deaths were seen at a dose level of 2008 mg/kg during the preliminary study.

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 008 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 008 mg/kg bw

Based on:

test mat.

Remarks:

No mortality observed at highest dose tested

Mortality:

There were no deaths in any of the treated animals during the observation period.

Clinical signs:

other: There were no changes in behaviour or clinical signs in any of the treated animals during the observation period.

Other findings:

There were no macroscopic findings that could be associated with treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no effect of treatment in any of the parameters examined.
From the results obtained under the experimental conditions employed, the LD0 by cutaneous route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.

Executive summary:

NECTARYL was tested to evaluate the acute toxicity following a single dermal administration (limit test) in rats according to the Guideline No. 402.

An acute toxicity study was conducted using rats. Ten animals were treated with a one-time application of Nectaryl, applied semi-occluded to the skin, at a dose of 2008 mg/kg. Clinical evaluations were performed 15 minutes after application, at 1, 2, and 4 hours, then daily for 14 days. There were no treatment related deaths during the study. A necropsy was performed on all animals after the 14 day study period. There were no clinical pathological signs noted. The study concluded that the cutaneous LD0 for Nectaryl in rats was equal to or greater than 2008 mg/kg.

LD50 dermal > 2008mg/kg, no mortalities or pathological clinical signs.