Hydroxy(2-methylprop-2-enoato-O)zinc

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 March - 09 April 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 405 without deviation

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: audited draft report

Title:

Unnamed

Year:

2013

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)

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxy(2-methylprop-2-enoato-O)zinc

EC Number:

264-202-2

EC Name:

Hydroxy(2-methylprop-2-enoato-O)zinc

Cas Number:

63451-47-8

Molecular formula:

C4H6O3Zn

IUPAC Name:

hydroxy(2-methylprop-2-enoato-O)zinc

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Zinc monomethacrylate / Dymalink 709
- Physical state: White powder
- Lot/batch No.: 1210223357
- Production date: October 2012
- Date received: 25 February 2013
- Expiration date of the lot/batch: January 2014
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome, Linxe, France
- Age at study initiation: 12 or 13 weeks
- Weight at study initiation: 2.37-2.96 kg
- Housing: Animals were kept in individual boxes installed in conventional air conditioned animal husbanding.
- Diet: Food (SAFE – 112), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: Approximately 10-15 changes per hour
- Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1 h (physiological rinse was done at 1 h post-installation)

Observation period (in vivo):

21 days
- Examination of the eyes was made after 1, 24, 48 and 72 h and Days 7, 14 and 21 after treatment.

Number of animals or in vitro replicates:

3 females

Details on study design:

TREATMENT
- Initially, a single animal was treated. After consideration of the responses produced on Day 7 in the first treated animal, two additional animals were treated.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Physiological rinse was done on Day 0 (at 1 h post-installation) to remove the remaining test item.
- Time after start of exposure: 1 h

SCORING SYSTEM: According to OECD Guideline 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The ocular reactions observed during the study have been moderate to important and totally reversible:
- at the conjunctivae level: an important redness noted 24 h after the test item instillation and totally reversible between Days 7 and 14, associated with a moderate to important chemosis noted 24 h after the test item instillation and totally reversible on Day 7;
- at the iris level: a congestion, noted 24 h after the test item instillation, and totally reversible between Days 2 and 3;
- at the corneal level: a moderate corneal opacity, noted 24 h after the test item instillation, and totally reversible between Days 7 and 21.
A corneal neovascularization was noted on Day 7 in one animal and on Day 14 in a second one. This reaction was totally reversible between Days 14 and 21.

Other effects:

None

Any other information on results incl. tables

See the attached document for information on tables of results

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, Zinc monomethacrylate / Dymalink 709 is classified as “R36 irritating to eyes”, according to the criteria of Annex VI to the Directive 67/548/EEC and "Category 2A - irritating to eyes" according to CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy female rabbits of the New Zealand White strain were exposed to 0.1 g of test item, Zinc monomethacrylate / Dymalink 709 in one eye while the another eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. Physiological rinse was done on Day 0 (at 1 h post-installation) to remove the remaining test item. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 7, 14 and 21 after treatment and graded according to the method of OECD Guideline 405. Initially, a single animal was treated and after consideration of the responses produced on Day 7 in the first animal, two additional animals were treated.

The ocular reactions observed during the study have been moderate to important and totally reversible. At the conjunctivae level, an important redness noted 24 h after the test item instillation and totally reversible between Days 7 and 14, associated with a moderate to important chemosis noted 24 h after the test item instillation and totally reversible on Day 7; at the iris level, a congestion, noted 24 h after the test item instillation, and totally reversible between Days 2 and 3; at the corneal level, a moderate corneal opacity, noted 24 h after the test item instillation, and totally reversible between Days 7 and 21. A corneal neovascularization was noted on Day 7 in one animal and on Day 14 in a second one. This reaction was totally reversible between Days 14 and 21. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 2.0, 2.0, 2.0 for cornea score; 0.7, 0.7, 0.3 for iris score; 2.3, 2.7, 2.7 for conjunctivae score and 1.3, 2.7, 2.3 for chemosis score. In this study, test item is an eye irritant on female rabbits.

 

Under the test conditions, Zinc monomethacrylate / Dymalink 709 is classified as “R36 irritating to eyes”, according to the criteria of Annex VI to the Directive 67/548/EEC and "Category 2A - irritating to eyes" according to CLP Regulation (EC) N° (1272-2008).