(pentabromophenyl)methyl acrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29/10/2001-12/11/2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP comparable to OECD guideline

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:

study report

Title:

Unnamed

Year:

2001

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)

Principles of method if other than guideline:

/

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

FR-1025M

IUPAC Name:

FR-1025M

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FR-1025M
- Substance type: Monomer
- Physical state: powder
- Analytical purity: 99.78%
- Lot/batch No.:010038
- Stability under test conditions:14/08/2002
- Storage condition of test material:at room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: 1-3.5 kg
- Housing: individually in labelled cages with perforated floors.
- Diet (e.g. ad libitum): +/- 100g per day / hay twice a week
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 96.7 (95.6-98.6) mg

Duration of treatment / exposure:

24hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 2% fluorescein in water + to remove residual test substance, rinsed with approximately 50ml tepid water
- Time after start of exposure: 24 hours

SCORING SYSTEM:Corneal irritation (Opacity: degree of density): 0-4
Iridic irritation: 0-2, Conjunctival irritation: Redness: 0-3, Chemosis: 0-4, Discharge: 0-3

TOOL USED TO ASSESS SCORE: standard lighting or an ophthalmic examination lamp.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean 24-72 hours

Score:

0.3

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean 24-72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean 24-72 hours

Score:

0

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean 24-72 hours

Score:

0

Max. score:

2

Reversibility:

not specified

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean 24-72 hours

Score:

0

Max. score:

2

Reversibility:

not specified

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean 24-72 hours

Score:

0

Max. score:

2

Reversibility:

not specified

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean 24-72 hours

Score:

2.3

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean 24-72 hours

Score:

2

Max. score:

3

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean 24-72 hours

Score:

0.7

Max. score:

3

Reversibility:

not specified

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean 24-72 hours

Score:

1

Max. score:

4

Reversibility:

not specified

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean 24-72 hours

Score:

0.3

Max. score:

4

Reversibility:

not specified

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean 24-72 hours

Score:

0

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

In one animal, corneal injury was seen as opacity (maximum grade 1) and epithelial damage (max. 5% of the corneal area). The opacity had resolved within 48 hours and the epithelial damage within 72 hours.
Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in all animals.
No irridial irritation was observed.

Other effects:

Corrosion, colouration, toxicity/mortality: no

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelins in Commision Directive 93/21/EEC), FR-1025M does not have to be classified and has no obligatory labelling requirement for eye irritation.
However according to CLP-Regulation (EC) No 1272/2008, FR-1025%M is classified as Irritating to eyes (Category 2) as at least in 2 of 3 tested animals, a positive response of conjunctival redness >=2.

Executive summary:

The study was carried out based on the guidelines described in: EC B5 and OECD 405.

Single samples of approximately 97 mg of FR-1025M were instilled into one eye of each of three rabbits. Two animals were examined 1, 24, 48 and 72 hours and 7 days after instillation. In addition, one animal was examined 1, 24, 48 and 72 hours and 7 days after instillation.

Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae. In one animal, corneal injury was seen as opacity (max grade 1) and epithelial damage (max 5% of the corneal area). The opacity had resolved within 48 hours and the epithelial damage within 72 hours.

Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in all animals.

Remnants of the test substance were present in the eyes of all animals on day 1 and/or day 2.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (93/21/EEC), FR-1025M does not have to be classified and has no obligatory labelling requirement for eye irritation.