2-phenylhexanenitrile

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 30 January 1995 and 13 February 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.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (UK) Ltd., Petersfield, Hampshire, England and Interfauna U.K. Ltd., Huntingdon, Cambridgeshire, England.
The animals were in the weight range of 2.6 to 2.9 kg and approximately 11 to 12 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 and plastic cages with perforated floors in Building R 14 Room 5 and 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 by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly summaries.
The mean minimum and maximum animal room temperature was 19°C and 20°C and relative humidity 50% and 59%. 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

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and was used for control purposes.

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Up to 1 hour

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

TREATMENT PROCEDURE
The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed (pilot animal see Table 1).
Approximately 0.1 ml of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.

OBSERVATIONS
Clinical signs: All animals were observed daily for signs of ill health or toxicity.
Ocular responses: Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

other: All animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The numerical values given to the ocular reactions elicited by Salicynalva are shown in Table 1 (please see the any other information on results section).
Dulling of the normal lustre of the cornea was seen in two animals one hour after instillation.
No iridial inflammation was observed.
Hyperaemia or diffuse crimson colouration of the palpebral and bulbar conjunctivae with slight swelling or partial eversion of the eyelids was seen in all three animals one hour after treatment.
The eyes were normal one day after instillation.

Other effects:

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

Ocular reactions observed after instillation of Salicynalva

 

Rabbit number and sex	Region of Eye		One hour	Day after instillation
				1	2	3	4	7
380 Female*	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	0	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
484 Male	Cornea		D	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	0	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
485 Male	Cornea		D	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	0	0	0	0	0	0
		Chemosis	0	0	0	0	0	0

 

*    Pilot animal

D  Dulling

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance is not an eye irritant in the OECD 405 test.

Executive summary:

A study was performed to assess the eye irritation potential of Salicynalva to the rabbit according to EU Method B.5 and OECD TG 405. Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for seven days after instillation. A single instillation of Salicynalva into the eye of the rabbit elicited transient dulling effect on the cornea of 2/3 animals after 1 hour. No effects were observed at the other time points. In conclusion, the test substance is not irritating to the skin in accordance with EU CLP (EC no 1272/2008 and its amendments).