Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 17th, 2009 - February 27th, 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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
minor deviation: only 2 instead of 3 animals tested, which was not found to be critical, as the test results were clearly negative
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.69 and 2.89 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

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped using veterinary clippers
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water
Duration of treatment / exposure:
Single application, exposure period:
First rabbit: 3 min, 1 hour, 4 hours (on 3 different sites on the dorsum and dorsal flank area)
Second rabbits: 4 hours
Observation period:
72 hours
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: dorsal flank area (2.5 cm x 2.5 cm)
- Type of wrap if used: cotton gauze patch, surgical adhesive tape, trunk of rabbit wrapped in an elasticated corset for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water after the exposure time

SCORING SYSTEM: Draize Scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable

Any other information on results incl. tables

3-minute and 1-hour semi occluded applications of the test material to the intact skin of the first rabbit produced no evidence of skin irritation.

A single 4-hour, semi-occluded application of the test material to the intact skin of two rabbits produced no evidence of skin irritation.

All animals showed expected gain in bodyweight during the study.

Table 1: Individual skin examination scores after 4h-exposure to SH-1

(Scoring according to Draize scheme)

 

Skin effect

Erythema

Edema

Scoringa

1 h

24 h

48 h

72 h

Meanb

1 h

24 h

48 h

72 h

Meanb

Animal No. /sex

 

 

 

 

 

 

 

 

 

 

#1 / m

0

0

0

0

0.0

0

0

0

0

0.0

#2 / m

0

0

0

0

0.0

0

0

0

0

0.0

aTimepoint of reading after substance removal subsequent to 4h-dermal exposure

bMean of 24, 48 and 72 h scores

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating to rabbit skin.
Executive summary:

In a primary dermal irritation study, the skin irritation/corrosion potential of Benzene, 1,1'-(1,2-ethanediyl)bis-, brominated was tested. The clipped dorso-lateral skin of two male New Zealand White rabbits was exposed to 0.5 mg test material in 0.5 mL distilled water for 4 hours under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme 1, 24, 48 and 72 hours after removal of the test substance.

The exposure period of up to 4 hours produced no evidence of skin irritation at any of the observation intervals.

Based on the study results, the test substance is non-irritating to the skin of rabbits and therefore not classified according to EU classification and OECD GHS classification criteria.