Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

29 November 2001 - 13 December 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

441-420-8

EC Name:

-

Cas Number:

113889-23-9

Molecular formula:

C14H20O2

IUPAC Name:

Reaction mass of 3a, 4, 5, 6, 7, 7a-hexahydro-1H-4, 7-methanoinden-5-yl butyrate and 3a, 4, 5, 6, 7, 7a-hexahydro-1H-4, 7-methanoinden-6-yl butyrate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: at least 200 g
- Housing: in suspended polypropene cages furnished with wood flakes, individually during exposure, in groups of five for the remainder of the
study.
- Diet: ad libitum. Certified Rat and Mouse Diet (Code 5LF2) supplied by PMI Nutrition International, Nottingham, UK.
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hrs light, 12 hrs dark. (from 06:00 to 18:00 light)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flank of the animal
- % coverage: approximately 10 % of body surface
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin and surrounding hair wiped with cotton wool, moistened with distilled water, to remove any residual test material.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.94 ml/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual bodyweights prior to dosing and 7 and 14 days after treatment. Mortality and clinical observations 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days. - Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 0/10 deaths

Mortality:

No mortality was observed

Clinical signs:

other: No signs of systemic toxicity were observed

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

Not reported

Applicant's summary and conclusion

Interpretation of results:

other: Not acute dermally toxic

Remarks:

according to EU CLP (EC1272/2008 and its amendments)

Conclusions:

Under the conditions of this test, the acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bw.

Executive summary:

An acute dermal toxicity test (limit test) was performed with cyclobutanate as testing material. The test was performed according to OECD guideline 402 (Acute dermal toxicity) in a group of 10 rats (5 males, 5 females). The rats were dermally exposed to the substance at 2000 mg/kg bw for 24 hours. The substance was applied to a shorn skin (approximately 10% of body surface) using a graduated syringe. A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. No mortality was observed in the 14 days period after exposure. No signs of systemic toxicity were observed during clinical observation. No signs of dermal irritation were noted in male animals. Very slight erythema was noted in all female animals one to three days after dosing. No abnormalities were noted at necropsy. Body weight of all animals increased during study. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be >2000 mg/kg bw. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).