Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2002 - January 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiences, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromodecane
EC Number:
203-955-3
EC Name:
1-bromodecane
Cas Number:
112-29-8
Molecular formula:
C10H21Br
IUPAC Name:
1-bromodecane
Details on test material:
Description: colorless liquid
Assay: 99.32%w
Water: 60 mg/kg
Container: glass flask
Storage conditions: at room temperature and protected from light
Expiry date: September 2003

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
On the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.5 ± 0.1 kg.
Acclimatation: at least 5 days before the beginning of the study.
Identification : individual ear tag.

The conditions in the animal room were set as follows:
- temperature: 18±3°C
- relative humidity: 30 to 70%
- light/dark cycle: 12h/12h
- ventilation: approximately 12 cycles/hour of filtered, non-recycled air
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.

The animals were housed individually in polystyrene cages (48.2 x 58 x 36.5 cm).
Each cage was equiped with a food container and a water bottle.

All the animals had free access to 110 pelleted diet.
Food is analysed regularly by the supplier for composition and contaminant levels.

Drinking water filtered by a FG Millipore membrane (0.22 µm) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitroamines).
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Other flank of the animals
Amount / concentration applied:
Doses of 0.5 mL of the test item were placed on a dry gauze pad, which then applied to the flank of the animals.
Duration of treatment / exposure:
In first instance, duration of exposure was 3 minutes on one flank and 4 hours on the other flank on a single animal.

Since the test item was no irritant on the first animal, it was then applied for 4 hours to two other animals.
Observation period:
The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. Since there was persistent irritation reactions at 72 hours, the observation period was extended. In the absence of complete reversibility of skin reactions on day 15, the study was ended.
Number of animals:
One in first instance and 2 for the second run.
Details on study design:
The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined in order to check the absence of any signs of skin irritation. Clipping was repeated.

The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

The untreated skin served as control.

After the removal of the dressing of the first animal, residual test item was wiped off by means of a dry cotton pad.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 13 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 72 h
Score:
2.67
Max. score:
8
Other effects:
After a 4-hour exposure, dryness of the skin were observed in all animals between day 2 and day 13.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material was determined to be moderately irritating, scoring a PDII of 2.67 out of 8
Executive summary:

The skin irritation potential of the test material was determined according to the following guidelines, OECD 404 and EU Method B4. Three rabbits were exposed to 0.5 mL of the test material for 4 hours, the site was then observed at intervals over a period of 15 days. The test material was determined to be moderately irritating, scoring a PDII of 2.67 out of 8.

Very slight erythema persists on the three animals after 15 days.

Under Regulation 1272/2008 the test material should be classified as "Skin Irrit. 2" and assigned the hazard phrase "H315: Causes Irritation to the Skin" and signal word "Warning".