[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 12 to 26 June 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline No. 402 without any deviation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987.

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 2012-04-23&24 / Signed on 2012-07-18.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2R,4aR,8aS)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one

Molecular formula:

C16 H26 O

IUPAC Name:

(2R,4aR,8aS)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one

Constituent 2

Reference substance name:

(2S,4aS,8aR)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one

Molecular formula:

C16 H26 O

IUPAC Name:

(2S,4aS,8aR)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one

Test material form:

solid: crystalline

Details on test material:

- Physical state: white crystals
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (539040 Le Genest St Isle-France)
- Age at study initiation: 7- 8 weeks
- Weight at study initiation: 220 - 236 g (males) and 193 - 205 g (females).
- Housing: Animals were housed individually during the 24 h exposure period and in groups of five by sex for the remainder of the study in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: foodstuff (M20-SDS), ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 10-15 changes/h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From 12 to 26 June, 2012

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

paraffin oil

Details on dermal exposure:

TEST ITEM FORMULATION AND EXPERIMENTAL PREPARATION
- 2 g and 4 g of the test item was weighed and liquid paraffin was added to a 10 and 20 mL volumetric flask respectively. The preparation was magnetically stirred to obtain a yellow solution just before the administration.

TEST SITE
- Area of exposure: Back and flank area
- % coverage: The appropriate amount of test item, moistened with liquid paraffin, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area).
- 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 (if done): The bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with liquid paraffin followed by distilled water to remove any residual test item. The animals were returned to group housing for the remainder of the study period.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- 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:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality or clinical signs of toxicity at 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.
- Necropsy of survivors performed: Yes; at the end of the study animals were killed by cervical dislocation and subjected to gross necropsy.

Statistics:

None

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: No mortality was observed.

Mortality:

No mortality was observed.

Clinical signs:

other: - No signs of systemic toxicity were noted during the observation period. - Dermal reactions: no cutaneous reactions related to the administration of the test item was observed.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the dermal LD50 Combined for test substance is higher than 2000 mg/kg bw in rats. Therefore, the substance is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute dermal toxicity study (limit test) performed according to OECD Guideline No. 402 and in compliance with GLP, a group of Sprague Dawley rats (5/sex) was given a single dermal application of the test material to intact skin of the back and flank area at a dose level of 2000 mg/kg bw. Test sites were covered with a semi-occlusive dressing for 24 h. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Skin irritation was assessed and scored according to the Draize scale at 24 h after removal of the dressings and then daily for 14 days. 

No mortality or systemic toxicity was observed. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. All animals showed gains in body weight over the observation period. No abnormalities were noted at necropsy.

 

Dermal LD50 Combined > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS. 

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.