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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:
08.04.2002 - 17.05.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-decyltetradecanoic acid
EC Number:
298-190-5
EC Name:
2-decyltetradecanoic acid
Cas Number:
93778-52-0
Molecular formula:
C24H48O2
IUPAC Name:
2-decyltetradecanoic acid
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Isocarb 24
- Substance type: Product
- Lot/batch No.: ISC2403, 04058/MA
- Physical state: crystalline at ambient conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S. p. A. (Como), Italy (supplier), P. O. A. D. A., Mandello Lario (Como),Italy (breeder)
- Age at study initiation: 9 – 11 weeks
- Weight at study initiation: about 2 kg
- Housing: Animals were individually housed in stainless steel cages measuring 69 x 45 x 51 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary. Throughout the study each cage was identified by a colour coded label recording the study number, animal number and the details of treatment. This colour coding matched the corresponding colour coded formulation container.
- Diet (e.g. ad libitum): commercially available antibiotic free pelleted laboratory diet (AItromin MSK, Altromin, D-32770 Lage, Postfach 1120, Germany) ad libitum throughout the study.
- Water (e.g. ad libitum): Animals were offered drinking water supplied to each cage via water bottles
- Acclimation period: at least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%.
- Air changes (per hr): 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 l 12

IN-LIFE DATES: From: To: 13.05.2002 - 17.05.2002

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 g
- Concentration (if solution): with 1 ml sterile water

Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: A 0.5 g aliquot of the supplied test item was reduced to a paste with 1.0 ml of sterile waterThe test article was applied undiluted.
- Area of exposure: The test substance was applied to a gauze patch (2.5 cm x 2.5 cm). The gauze square was then placed onto the animal's skin with the test item in direct contact with the skin. A strip of aluminium foil was placed over the treated site and the whole assembly held
in place by encircling the trunk of the animal ith a length of elastic adhesive bandage, this forming a semi-occlusive barrier.The patch was placed on the appropriate test field. A strip of aluminium foil was placed over the treated site and the whole trunk was wrapped with an elastic adhesive bandage.
- Occlusion: semi-occlusion
- Vehicle: none
- Postexposure period: 72 h
- Removal of test substance: After a period of 4 hours, the adhesive bandage and gauze patch were removed from the treated site of each animal which was cleaned by gentle swabbing of the skin with cotton wool soaked in water at approximate body temperature.
EXAMINATIONS
- Scoring system: according to OECD 404
- Examination time points: Skin reactions were read immediately and 1, 24, 48 and 72 hours after the end of the exposure period

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritation or other reaction was apparent on the treated skin of any animal.
Other effects:
Changes in body weight during the course of the study were not remarkable. There was no indication of a systemic effect of treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal irritation of 2-decyltetradecanoic acid was investigated in the rabbit. A 0.5 g aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after the end of the exposure period. No irritation was apparent following a 4 hour period of exposure to the substance. These results indicate that the test substance has no irritant effect on the skin of the rabbit.
Executive summary:

These results indicate that the test substance has no irritant effect on the skin of the rabbit.