2-phenylhexanenitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 24th and 29th January 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-phenylhexanenitrile

EC Number:

423-460-8

EC Name:

2-phenylhexanenitrile

Cas Number:

3508-98-3

Molecular formula:

C12 H15 N

IUPAC Name:

2-phenylhexanenitrile

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 2.1 to 3.2 kg and approximately 9 to 14 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 plastic cages with perforated floors in Building R 14 Room 1.
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 physical and 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.
The mean minimum and maximum animal room temperature was 19.5°C and 20.5°C and relative humidity 55 % and 61 % . 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 license.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

5 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-lumbar 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 60 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 and 6.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 383 female

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: 297 male

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

erythema score

Basis:

animal: 410 female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal: 383 female

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 5

Irritation parameter:

edema score

Basis:

animal: 297 male

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

edema score

Basis:

animal: 410 female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The numerical values given to the dermal reactions elicited by Salicynalva are shown in Table 1 (please see any other information on results section).
Well-defined erythema with very slight oedema was seen in two rabbits.
Very slight erythema alone was seen in the third animal.
The application sites were normal on days 2, 5 or 6.

Other effects:

There were no signs of ill health in any rabbit during the observation period. There were very slight to well-defined dermal reactions found within the study however this was not enough to trigger classification for this endpoint.

Any other information on results incl. tables

TABLE 1

Dermal reactions observed after application of Salicynalva

Rabbit number and sex	E = Erythema O = Oedema	Day
		1*	2	3	4	5	6
383 female	E O	2 1	2 1	2 1	2 1	1 0	0 0
297 male	E O	2 1	2 1	2 1	1 0	0 0
410 female	E O	1 0	0 0	0 0	0 0

* Approximately 60 minutes after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:

other: Not a skin irritant in accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

The substance does not cause skin irritation in the OECD 404 test

Executive summary:

This study was performed to assess the skin irritation potential of Salicynalva to the rabbit according to EU Method B.4 and OECD TG 404. Three rabbits were each administered a single dermal dose of 0. 5 ml of the test substance and observed for a maximum of six days. A single semi-occlusive application of Salicynalva to intact rabbit skin for four hours elicited very slight to well-defined dermal reactions. The erythema scores were 2, 1.67, and 0 and the edema scores were 1, 0.67, and 0, respectively. The reactions had resolved within 6 days. In conclusion, the test substance is not irritating to the skin in accordance with EU CLP (EC no 1272/2008 and its amendments).