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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-09-18 to 2008-09-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, 2002-04-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2007-10-15

Test material

Constituent 1
Chemical structure
Reference substance name:
700-380-4
EC Number:
700-380-4
Molecular formula:
A: C25H50O2 B: C27H54O2
IUPAC Name:
700-380-4
Details on test material:
- Name of test material (as cited in study report): Sym08/181598
- Synonym: SymMollient S
- Molecular formula: A: C25H50O2; B: C27H54O2
- Molecular weight: A: 382.68 g/mol; B: 410.73 g/mol
- Physical state: Colourless liquid to solid
- Storage condition of test material: Ambient temperature (10 - 30 °C), dark, dry, in original container
No further information on the test material was stated.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: weight range of 2.0 to 3.5 kg (Animal no. 1: 2.87 kg; Animal No. 2: 2.92 kg and Animal No. 3: 2.71 kg)
- Housing: The animals were individually housed in suspended cages.
- Diet (ad libitum): 2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water (ad libitum): Mains drinking water
- Acclimation period: At least five days
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Relative humidity: 30 to 70 %
- Air exchanges: At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test material was applied.
No further information on the amount/concentration applied was stated.

Duration of treatment / exposure:
4h
Observation period:
Approximately one hour following removal of the patches, and 24, 48 and 72 hours later
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit.
- Type of wrap if used: The test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Four hours

SCORING SYSTEM: Draize scoring system was used.

OTHER OBSERVATIONS:
Any other skin reactions, if present, were also, recorded.
No further information on the study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No evidence of skin irritation was noted during the study.
Other effects:
All animals showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as an skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as an skin irritant.

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