2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November1995-January 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study done under OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol

EC Number:

500-399-6

EC Name:

2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol

Cas Number:

158725-44-1

IUPAC Name:

NA

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

F-3014
Batch number 016
Data received 2 October 1995
Description White solid
Storage conditions room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.62-2.86 Kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK
- Water (e.g. ad libitum): mains drinking water
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 49-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 gr

Duration of treatment / exposure:

1 second. The test material (100g) was placed into the cojuctival sac of the right eye, by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, then released.

Observation period (in vivo):

Assessment of ocular damage/ irritation was made approx. 1 hr and 24, 48, and 72 hr following treatment.

Number of animals or in vitro replicates:

1 initial and five additional animals

Details on study design:

see attched file (materials and methods, procedure and interpretation of results)

Results and discussion

In vivo

Results

Irritation parameter:

other: Cornea, Iris and Conjunctivae scores

Basis:

mean

Time point:

other: up to 72 hr observation (24, 48 and 72)

Score:

9

Max. score:

9

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Residual test material was noted around the treated eye of all animals 1 hr after treatment.
No corneal effects were noted during the study
iridial inflammation was noted in four treated eyes 1 hr after treatment. No other iridial effects were noted.
Minimal to moderate conjunctival irritation was noted in all treated eyes 1 hr after treatment. Minimal conjunctival redness persisted in four treated eyes at the 24 hr observation.

Applicant's summary and conclusion

Interpretation of results:

other: Minimal irritant

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material F-3014, produced a maximum group mean score of 9 and was classified as a Minimal Irritant (Class 3 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbol and risk phrase are required.

Executive summary:

The test material F-3014, produced a maximum group mean score of 9 and was classified as a Minimal Irritant (Class 3 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbol and risk phrase are required.