2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl-, 2-ethylhexyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

27 April 2010 to 08 May 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl, 10-undecen-1-yl ester

IUPAC Name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl, 10-undecen-1-yl ester

Constituent 2

Reference substance name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl-, undecenyl ester

IUPAC Name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl-, undecenyl ester

Constituent 3

Reference substance name:

Undecenyl methoxycrylene

IUPAC Name:

Undecenyl methoxycrylene

Constituent 4

Reference substance name:

700-824-2

IUPAC Name:

700-824-2

Constituent 5

Reference substance name:

947701-81-7

Cas Number:

947701-81-7

IUPAC Name:

947701-81-7

Details on test material:

Sponsor's identification : Undecenyl methoxycrylene
Description : amber coloured viscous liquid
Batch number : ABP5032410
Date received : 12 April 2010
Expiry date: 12 April 2012
Storage conditions : room temperature in the dark

The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK.

- Age at study initiation: 12 to 20 weeks old.

- Weight at study initiation: At the start of the study the animals were in the weight range of 2.34 to 2.41 kg.

- Housing: The animals were individually housed in suspended cages.

- Diet (e.g. ad libitum): Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.

- Water (e.g. ad libitum): Free access to mains tap water was allowed throughout the study.

- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C

- Humidity (%): 30 to 70%,

- Air changes (per hr): The rate of air exchange was approximately fifteen changes per hour

- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

2 (male)

Details on study design:

A single rabbit was treated initially. The test material was placed into the conjuctival sac of the right eye. The left eye remained untreated and served as a control. Immediately after administration, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1.

Based on the results from the first animal, a second animal was treated.

Assessment of ocular damage/irritation was made appoximately 1 hour and 24, 48 and 72 hours following treatment according to J.H. Draize (1977). See Table 2.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: group mean score

Basis:

mean

Time point:

other: 1 hour

Score:

11

Max. score:

110

Results 2

Irritation parameter:

other: group mean score

Basis:

mean

Time point:

other: 24 hours

Score:

5

Max. score:

110

Results 3

Irritation parameter:

other: group mean score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Max. score:

110

Results 4

Irritation parameter:

other: group mean score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

110

Irritant / corrosive response data:

See Table 3

Other effects:

The initial pain response value for Animal 69151 was 2.
The initial pain response value for Animal 69181 was 2.

Any other information on results incl. tables

Table 3: Individual Scores

Rabbit Cornea Iris Conjunctivae Total Number Hour A (Opacity) B (Area) (A x B x 5) A A X 5 A (Redness) B (Chemosis) C (Discharge) (A + B + C) x 2 Score 69151 1 0 0 0 0 0 2 (sf) 2 1 10 10 24 0 0 0 0 0 1 (sf) 1 0 4 4 48 0 0 0 0 0 0 (sf) 0 0 0 0 72 0 0 0 0 0 0 (sf) 0 0 0 0 69181 1 0 0 0 0 0 2 (sf) 2 2 12 12 24 0 0 0 0 0 1 (sf) 1 1 6 6 48 0 0 0 0 0 0 (sf) 0 0 0 0 72 0 0 0 0 0 0 (sf) 0 0 0 0

sf = yellow colored staining of the fur around the treated eye

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Kay and Calandra classification system

Conclusions:

The test material produced a maximum group mean score of 11.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to the Kay and Calandra classification system.