Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 10th, 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, only 2 instead of 3 animals tested
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SH-1
- Chemical name of test material (as cited in study report): Benzene, 1,1'-(1,2-ethanediyl)bis-, brominated
- Composition of test material, percentage of components:
-- 0-2 % Penta bromodiphenylethane (CAS No.: 137563-31-6)
-- 40-80 % Hexa bromodiphenylethane (CAS No.: 137563-32-7)
-- 1-20 % Hepta bromodiphenylethane (CAS No.: 137563-33-8)
-- 1-30 % Octa bromodiphenylethane (CAS No.: 137563-34-9)
-- 0-10 % Nona bromodiphenylethane (CAS No.: 137563-35-0)
-- 0-5 % Deca bromodiphenylethane (CAS No.: 137563-36-1, 84852-53-9)
- Physical state: white powder
- Analytical purity: > 99%
- Batch No.: 20090105
- Expiration date of the lot/batch: January 08th, 2011
- Storage condition of test material: 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: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.94 and 3.01 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): mains drinking water
- Water (e.g. ad libitum): diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: February 10th, 2009 To: February 10th, 2009

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (approx. 16 mg)
Duration of treatment / exposure:
single application, eyes were not washed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
individual score of animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
individual score of animal #2
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
The rabbits showed the expected gain in body weight during the study.

Any other information on results incl. tables

Table 1: Results of eye irritation test: Individual Scores according to Draize scheme:

Rabbit No. / sex

Scoring [h]

Cornea

Iris

Conjunctiva

Redness

Chemosis

1 / m

1

0

0

2

1

 

24

0

0

1

0

 

48

0

0

1

0

 

72

0

0

0

0

Mean (24, 48, 72 h)

0.0

0.0

0.7

0.0

2 / m

1

0

0

2

1

 

24

0

0

1

0

 

48

0

0

0

0

 

72

0

0

0

0

Mean (24, 48, 72 h)

0.0

0.0

0.3

0.0

Group mean

0.0

0.0

0.5

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results, the test substance is not irritating to eyes.
According to EU classification and OECD GHS classification criteria, no classification is required
Executive summary:

In an eye irritation study, 0.1 mL (approx. 16 mg) of undiluted test substance was instilled into the conjunctival sac of one eye of two male New Zealand White rabbits. The animals were observed for 72 hours. Irritation was scored according to Draize.

Moderate conjunctival irritation was noted in both treated animals 1 hour after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 24 -hour observation and in one treated eye at the 48 -hour observation interval. Both treated eyes appeared normal at the 72 -hour observation interval.