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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 September 2012 to 11 January 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isodecyl acrylate
EC Number:
215-542-5
EC Name:
Isodecyl acrylate
Cas Number:
1330-61-6
Molecular formula:
C13H24O2
IUPAC Name:
2-methyloctyl prop-2-enoate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd., Bicester
- Age at study initiation: 13 to 14 weeks
- Weight at study initiation: 2.7 to 3.0 kg
- Housing: Individually housed in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures'
- Diet (e.g. ad libitum): Global Diet 2930C, ad libitum
- Water (e.g. ad libitum): Mains water, ad libitum
- Acclimation period: 7 to 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21°C
- Humidity (%): 45%
- Air changes (per hr): 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): Rooms illuminated by fluorescent strip-lights for twelve hours daily

IN-LIFE DATES: From: 18 September 2012 to: 05 October 2012

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL of undiluted test article instilled into the left conjunctival sac of each rabbit (one sentinel rabbit, followed by two further rabbits).
Duration of treatment / exposure:
Ocular reactions were assessed for up to 4 days after treatment.
Observation period (in vivo):
The treated animals were examined for ocular changes approximately 30 minutes, one and four hours after treatment and on Days 2, 3 and 4 (at approximately 24, 48 and 72 hours post-treatment.)
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
The test article did not demonstrate corrosive or severe irritant responses in a validated and accepted ex vivo test designed for the specific assessment of eye corrosivity/irritation (Covance study number 8268255), and did not demonstrate irritant responses in a validated and accepted in vitro test designed for the specific assessment of skin irritation (Covance study number 8268258).
Furthermore, before the first animal was dosed, the pH of the test article was checked, and found to be 5 (i.e. within the acceptable range of pH 2 to 11.5).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(3 rabbits)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(3 rabbits)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(3 rabbits)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(3 rabbits)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
Ocular instillation of the test article provoked practically no initial sting reaction.
There were no ocular responses noted other than minimal conjunctival discharge in one animal at 30 minutes and 1 hour after instillation.
Other effects:
No observations indicative of systemic toxicity or ill health were noted for any rabbits during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article produced a maximum group mean score of 0.6 and was considered to be practically non irritant according to the modified version of the system described by Kay and Calandra.
Executive summary:

This study was conducted to determine the irritancy caused to the rabbit eye following a single instillation of the test article, Isodecyl Acrylate, into the conjunctival sac.

The undiluted test article (0.1 mL) was instilled into one conjunctival sac of each of three New Zealand White rabbits on Day 1. Ocular reactions were assessed for up to 4 days after treatment.

Ocular instillation of the test article provoked practically no initial sting reaction.

There were no ocular responses noted other than minimal conjunctival discharge in one animal at 30 minutes and 1 hour after instillation.

The test article produced a maximum group mean score of 0.6 and was considered to be practically non-irritant according to the modified version of the system described by Kay and Calandra.

The test article did not meet the criteria for classification as irritant according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).