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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:
From to 21 July 2009 06 November 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in compliance with OECD Guideline 405 without major deviation.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
24 February 2009

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethyl-1,3-dioxolan-4-ylmethanol
EC Number:
202-888-7
EC Name:
2,2-dimethyl-1,3-dioxolan-4-ylmethanol
Cas Number:
100-79-8
Molecular formula:
C6H12O3
IUPAC Name:
(2,2-dimethyl-1,3-dioxolan-4-yl)methanol
Test material form:
liquid
Specific details on test material used for the study:
Name of test material (as cited in study report): PEX-01; 2,2-Dimetil-4-Hidroximetil-1,3-Dioxolano
- Physical state: Clear liquid
- Analytical purity: 99.5%
- pH of test substance = 6
- Composition of test material, percentage of components: 99.9% 2,2-Dimethyl-1,3-dioxolane-4-methanol; water: 0.02%; Acidity (Acetic acid): 0.0021%
- Lot/batch No.: 081001
- Expiration date of the lot/batch: 01 October 2009
- Stability under test conditions: Stable at room temperature and under normal conditions of use
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Natanael Alves Ferreira, São Roque - SP
- Age at study initiation: Approximately 3 months
- Weight at study initiation: At least 1.5 kg
- Housing: galvanized metal cages (Gaiolas Ipanema, 50 x 50 x 50 cm)
- Diet: Commercial diet for the species (Guabi, Santa Fé), ad libitum
- Water: filtered water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: from 18ºC to 22ºC
- Humidity: 70%
- Air changes: No data
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 08 September 2009 To: 29 September 2009.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye, which remained untreated, was used as the negative control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test item
Duration of treatment / exposure:
Washing of treated eyes 24 hours following application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye of the animals were rinsed after scoring with deionised water 24 hours following application

SCORING SYSTEM: According to the Draize method (OECD, 2002)

TOOL USED TO ASSESS SCORE:
- Observations at 24 hours, 48 hours, 72 hours, 7 days, 14 days and 21 days were performed with the aid of fluorescein to detect possible corneal abnormalities which are not grossly observable. Following an approximate 15 seconds exposure, both eyes were rinsed with water and further observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
- Signs of ocular irritation were observed at 1h, 24h, 48h, 72h, 7d and 14d.
- At 1h of observation, all animals presented opacity, conjunctivae redness and chemosis and two animals presented iritis.
- At 24 hours, all animals presented corneal opacity, conjunctival redness, chemosis and iritis. - At 48 hours, two animals presented opacity, iritis and chemosis and all animals presented conjunctivae redness.
- At 72 hours, all animals presented conjunctivae redness, two animals presented opacity and chemosis and one animal presented iritis.
- On day 7, ocular reactions were reverted in one animal, one animal presented chemosis and conjunctivae redness and one animal presented corneal opacity.
- On day 14, one animal presented conjunctivae redness and one animal presented opacity.
- All ocular reactions reverted on day 21.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Results of eye irritation

Rabbit Nº

Time

 Opacity

Area

Iritis

Conjunctival redness

Chemosis

1

1h

1

1

0

2

3

24h

1

1

1

2

1

48h

0

0

0

1

0

72h

0

0

0

1

0

7d

0

0

0

0

0

14d

0

0

0

0

0

21d

0

0

0

0

0

2

1h

1

1

1

2

3

24h

1

3

1

2

1

48h

1

2

1

2

1

72h

1

1

1

2

1

7d

0

0

0

1

1

14d

0

0

0

1

0

21d

0

0

0

0

0

3

1h

1

1

1

2

3

24h

1

3

1

2

1

48h

1

3

1

2

1

72h

1

2

0

2

1

7d

1

1

0

0

0

14d

1

1

0

0

0

21d

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions, PEX-01 is classified as Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) N° 1272-2008 (CLP) and Category 2A (H319: Causes serious eye irritation) according to GHS UN.
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted submitted substance 2,2-Dimethyl-1,3-dioxolane-4-methanol in their left eye while the right eye remained untreated and served as control. The treated eye of the animals was rinsed after scoring with deionised water 24 hours following application. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and up to Day 21 after treatment and graded according to the Draize method.


 


Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:


. corneal opacity: 0.3, 1 and 1


. iris lesions: 0.3, 1 and 0.7


. redness of the conjunctiva: 1.3, 2 and 2


. chemosis: 0.3, 1 and 1


Signs of ocular irritation were observed at 1h, 24h, 48h, 72h, 7d and 14d. All ocular reactions reverted on day 21. In this study, 2,2-Dimethyl-1,3-dioxolane-4-methanol is an eye irritant on male rabbits.


 


Under the test conditions, 2,2-Dimethyl-1,3-dioxolane-4-methanol is classified as Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) N° 1272-2008 (CLP) and Categor 2A (Cause serious eye irritation) according to GHS UN.