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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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C10-16
EC Number:
267-019-6
EC Name:
Alcohols, C10-16
Cas Number:
67762-41-8
IUPAC Name:
tetradecan-1-ol
Details on test material:
- Name of test material (as cited in study report): Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A). Equivalent to Alcohols, C12-13-branched and linear (CAS 740817-83-8).

- Physical state: clear, transparent liquid

- Storage condition of test material: at ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Young adults
- Weight at study initiation: 2.042 - 2.28 kg
- Housing: individually in stainless steel cages with perforated floor
- Diet: standard laboratory rabbit diet, ad libitum
- Water: tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 40-82.5
- Air changes (per hr): ca.10
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
Examination points: 1, 24, 48 and 72 hours then at 7 days (end of observation period)
Number of animals:
3M
Details on study design:
TEST SITE
- Area of exposure: back, 2.5x2.5 cm
- Type of wrap if used: self adhesive gauze, fastened with two strips of tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Using tissue moistened with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: individual mean 24+48+72 hour scores were 2 in all animals.
- Oedema: individual mean 24+48+72 hour scores were 1.3 in all animals.

REVERSIBILITY: The skin of all animals appeared normal at 7 days.
Other effects:
Slight scaliness was observed at 48 and 72 hours after  patch removal.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Following a 4 hour semi-occlusive exposure to rabbit skin this C12-C13, branched and linear (type 2) alcohol was found to be a mild irritant according to GHS as all individual scores for erythema were between 1.5 and 2.3 and group mean 24+48+72 hour score 2 for erythema. No classification would be triggered under EU criteria.

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