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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
other: group mean score
Basis:
mean
Time point:
other: 1 hour
Score:
11
Max. score:
110
Irritation parameter:
other: group mean score
Basis:
mean
Time point:
other: 24 hours
Score:
5
Max. score:
110
Irritation parameter:
other: group mean score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
110
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.