3-Cyclopentene-1-acetaldehyde, 2,2,3-trimethyl-, reaction products with Me Et ketone, hydrogenated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 - 27 March 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 402 without any deviation.

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

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol

EC Number:

939-525-3

Cas Number:

1471313-03-7

Molecular formula:

C14H26O

IUPAC Name:

3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol

Details on test material:

- Name of test material (as cited in study report): 3-METHYL-5-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENTAN-2-OL
- Physical state: Colourless liquid
- Analytical purity: sum of C14H26O isomers 95.4 %
- Lot/batch No.: C02030212
- Production date: 03 February 2012
- Date received: 15 February 2012
- Expiration date of the lot/batch: 02 February 2014
- Storage condition of test material: Room temperature, darkness

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier, Le Genest St Isle, France
- Age at study initiation: Males: 9 weeks; Females: 10 weeks
- Weight at study initiation: Males: 350-386 g; Females: 226-257 g
- Housing: Animals were housed in solid-bottomed clear polycarbonate cages with stainless steel mesh lid. Animals were housed individually during the treatment up to Day 8. On Day 9, the animals were housed 5/sex into their cage.
- Diet: Food (M20, SDS), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately 15/h
- Photoperiod: 12 h dark / 12 h light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: Approximately 10 % of the total body surface area
- Type of wrap if used: Test item was applied uniformly over an area which was approximately 10 % of the total body and held in contact with the skin with a porous gauze dressing and non-irritating tape throughout the exposure period. The test site was further covered under porous gauze dressing to ensure that the animals cannot ingest the test item.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Dose volume: 2.23 mL/kg bw (corresponding to 2005 mg/kg bw, according to the density of test item i.e., 0.899)
- Constant volume or concentration used: Yes

Duration of exposure:

24 h

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 signs: Animals were observed 1, 3, 5 and 24 h post administration and thereafter once a day up to 14 days.
Bodyweight was recorded on Day 0 (prior to dosing), then on Days 2, 7 and 14.
- Necropsy of survivors performed: Yes; on Day 14, all animals were anaesthetised with sodium pentobarbital and then administered sodium pentobarbital up to a lethal dose and all animals were subjected to a macroscopic examination.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: - No systemic clinical signs related to the administration of the test item were observed. - Erythema was noted on the treated area of all animals, 24 or 48 h post administration and was totally reversible on Day 3. Dryness was noted in one male and four

Gross pathology:

No macroscopic abnormalities were observed at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute dermal LD50 of the substance is higher than 2000 mg/kg bw in rats. Therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.

Executive summary:

In a GLP acute dermal toxicity study (limit test) performed according to OECD Guideline 402, a group of Sprague Dawley rats (5/sex/dose) were given a single dermal application of the substance at 2000 mg/kg bw. The test item was placed directly on dorsal area of the skin representing approximately 10 % of the total body surface area of the animals. The application site was then covered with a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No clinical signs and no mortality were observed during the study. Erythema was noted on the treated area of all animals, 24 or 48 h post application and was totally reversible on Day 3. Dryness was noted in one male and four females on Day 3 and was totally reversible between Days 7 and 9. Body weight was not affected by treatment with the test item throughout the study. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 was considered to be higher than 2000 mg/kg bw in rats.

Under the test conditions, the acute dermal LD50 of the substance is higher than 2000 mg/kg bw in rats. Therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.