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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January to April 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Directive CEE 84/449/CEE - annexe V
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dibromo-1,6-Hexane
- Substance type: colorless liquid
- Physical state: Liquid
- Purity: 98.4%
- Lot/batch No.: TVV 01-07
- Storage condition of test material: Packaged in a glass bottle and stored in aluminium foils

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Provided by the Abbey of Bellefontaine (49122 in Bégrolles en Mauges, France)
- Age at study initiation: adult males
- Weight at study initiation: Mean: 2.2+/- 0.1 kg
- Housing: The animals were housed individually in polystyrene cages equipped with a feeder and a bottle.
- Diet (e.g. ad libitum): ad libitum - granules for rabbit reference 112 C (U .A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum - Drinking water, filtered through a membrane with 0.22 micron Millipore (Company, 78140 Velizy, France)
- Acclimation period: During 5 days - with daily observations. Systematic prophylactic treatment is undertaken in order to avoid any risk of eventual multiplication coccidial by adding to the drinking water a solution of Mucoxid (R) at a dose of 140 mg/kg/day in a volume of 10 ml/kg (Veda-Coglès, 45140 Saint Jean de la Ruelle, France)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): air-conditioned room/ the air is not recycled but filtred.
- Photoperiod (hrs dark / hrs light): 12 H light - 12 H dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: right flank
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml is deposited on a square of gauze Codex (polyvinyl, 92402 Courbevoie. France) with an area of ​​about 6 cm2
- Concentration (if solution): undiluted

NO VEHICLE - substance is applied as such
Duration of treatment / exposure:
Exposition period: 4 hours on the left flank - No rinsing is carried out after treatment.
Observation period:
72 hours
Number of animals:
3 males: The single application is made on 01. 02 .1989 (J 1) on animal (No. 1) then 03/02/89 in 2 animals (No. 2 & 3). The animals are kept in
observation until the 4th day (72 hours).
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100% of 6 cm2 with 0.5 ml of testing substance
- Type of wrap if used: a square of gauze Codex hydrophilic (polyvinyl, 92402 Courbevoie. France)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing

SCORING SYSTEM:
Skin reactions are evaluated one hour, then 24, 48 and 72 hours after removal of the semi-occlusive dressing and then daily until the reversibility of the reactions using the following numerical scale : Directive 84/449/EEC:
* Erythema and eschar formation (form score 0 to 4)
* oedema formation (form score 0 to 4)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h mean
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hour mean
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hour mean
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: 1, 2 and 3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1 hours
Irritant / corrosive response data:
Under the current experimental conditions, the test substance 1,6-dibromohexane was considered as non-irritant by cutaneous route in Rabbit. The substance is consequently not classified for skin irritation.
Other effects:
No other effect reported in the report.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: criteria of EEC Directive 83/467/EEC, Commission dated 29th July 1983, according to the fifth adaptation of the technical progress council 67/548/EEC.
Conclusions:
Under the current experimental conditions, the test substance 1,6-dibromohexane was considered as non-irritant by cutaneous route in Rabbit an dis concequently not classified for skin irritation.
Executive summary:

Materials and Methods:

A single dose of 0.5 ml of the undiluted test substance was prepared on a dry dressing and then applied on a 6 cm2 clipped area of skin of 1 then 2 male New Zealand rabbits. The test substance was held in contact with the skin for 4 hours by a semi-occlusive dressi ng. The cutaneous reactions were observed 1 hour, 24, 48 and 72 hours after removal of the dressing. The test substance was not rinsed off after removal of the dressing. The interpretation of results was carried out according to the classification criteria laid down in the EEC Directive 83/467/EEC, Commission dated 29th July 1983, according to the fifth adaptation of the technical progress council 67/548 / EEC.

Results:

One hour after the removal of the dressing, a very slight erythema (score of 1 in animal 1) or/ and well-defined (score of 2 in animal 1) were observed. No oedema was noted. After 24 hours, the erythema was very slight in animal 1 and well - defined in 2 animals. After 48 hours, the erytnema was very slight in 3 animals. No cutaneous reactions were noted after 72 hours. According to this results the substance is not classified as skin irritant according the the criteria of Regulation EC 1272/2008 and amendments.