1-Propanol, 2-methyl-3-[(1,7,7-trimethylbicyclo[2.2.1]hept-2-yl)oxy]-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 09 March 1993 and 17 March 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-210-4

EC Name:

-

Cas Number:

128119-70-0

Molecular formula:

C14H26O2

IUPAC Name:

2-methyl-3-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-1-ol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
They were in the weight range of 2.2 to 3.0 kg and approximately 10 to 13 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in metal cages with perforated floors in Building R 14 Room 5.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms.
Results of routine chemical examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly summaries.
Animal room temperature was maintained at approximately 19°C. The mean minimum relative humidity was 44 % and the mean maximum was 57 %. These environmental parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage was identified by a coloured label displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A 0.5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal.

Duration of treatment / exposure:

4 hours

Observation period:

Up to 9 days

Number of animals:

3

Details on study design:

TREATMENT PROCEDURE
- Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-Iumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm. A 0.5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal. Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

OBSERVATIONS
- Clinical signs: All animals were observed daily for signs of ill health or toxicity.
- Dermal responses: Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure). Additional observations were made on Days 5 through 9.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1634

Time point:

24/48/72 h

Score:

1.667

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1655

Time point:

24/48/72 h

Score:

1.667

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 3

Irritation parameter:

erythema score

Basis:

animal: 1636

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

edema score

Basis:

animal: 1634 and 1636

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

edema score

Basis:

animal: 1655

Time point:

24/48/72 h

Score:

1.667

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Well-defined erythema with very slight or slight oedema was seen in all three animals. These reactions were accompanied in three animals by desquamation of the stratum corneum and in one animal by hyperkeratinisation (No. 1634). The dermal reactions gradually ameliorated and had resolved completely on Days 8 or 9.

Other effects:

CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Table 1 Dermal reactions observed after application of Bornafix

Rabbit number and sex	E = Erythema O = Oedema	Day
		1*	2	3	4	5	6	7	8	9
1634 male	E	2	a2	a2	a1	a1	b1	b1	0
	O	1	1	1	b1	b1	1	1	0
1655 male	E	2	2	2	1	1	b1	b1	1	0
	O	1	1	2	2	1	1	1	0	0
1636 male	E	1	2	2	2	1	b1	b1	0
	O	1	1	1	1	1	1	1	0

* Approximately 30 minutes after removal of the dressing a Hyperkeratinisation b Desquamation of the stratum corneum

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating according to EU CLP (1272/2008 and its amendments)

Conclusions:

In this study performed in accordance with EU Method B.4, the test substance is not considered to be a skin irritant.

Executive summary:

A study according to EU Method B.4 was performed to assess the skin irritation potential of Bornafix to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for a maximum of nine days. A single semi-occlusive application of Bornafix to intact rabbit skin for four hours elicited well defined dermal reactions. Erythema scores were 1.667, 1.667, and 2 and edema scores were 1, 1, and 1.667 for the three rabbits, respectively. All reactions had resolved by Day 8 or 9. Bornafix is non-irritant to rabbit skin.