Alcohols, C12-13-branched and linear

Skin irritation / corrosion

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

Test material information

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

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.