Alcohols, C13-15-branched and linear

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C13-15-branched and linear

EC Number:

287-625-4

EC Name:

Alcohols, C13-15-branched and linear

Cas Number:

85566-16-1

Molecular formula:

C13 H27 OH - C15 H31 OH

IUPAC Name:

Alcohols C13-C15 branched and linear, reaction products of C12-C14 olefines

Specific details on test material used for the study:

- Name of test material (as cited in study report): C13 - C15 - Alkohol
- Physical state: colorless liquid
- Analytical purity: 99.3% alcohols (0.5% low boiling substances, 0.2% high boiling substances)
- Composition of test material, percentage of components: 29.5% i-C13-alcohol, 33% n-C13-alcohol, 19% i-C15-alcohol, 17.8% n-C15-alcohol
- Lot/batch No.: from continuous production
- Sustance number: 88/577

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: mean(males): 3.13 kg, female: 2.82 kg
- Housing: single
- Diet: Kliba 341, 4 mm, Klingentalmuehle, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study (same housing conditions as during the study)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

15 days

Number of animals:

3 (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing: with lutrol and lutrol/water (1:1) at the end of the exposure period


SCORING SYSTEM: according to OECD 404 / Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

other: 24 - 48 - 72 h

Score:

2.6

Max. score:

4

Reversibility:

fully reversible within: 15 days

Remarks on result:

other: erythema score >/= 2 in 3 animals; see table below for details

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

other: 24 - 48 - 72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: see table below for details

Other effects:

(Severe) scale formation at 8 and 15 days after application of test substance in 3 animals.

Any other information on results incl. tables

Animal number	Evaluation Interval	Erythema	Oedema
1 2 3	4 hour	2 2 2	1 1 1
1 2 3	24 hours	3 3 2	1 0 1
1 2 3	48 hours	3 2 3	0 0 1
1 2 3	72 hours	3 1 3	0 0 1
1 2 3	8 days	1 1 2	0 0 0
1 2 3	15 days	0 0 0	0 0 0
1 2 3	ME	3.0 2.0 2.7	0.3 0.0 1.0
	ME	2.6	0.4

Calculation of the mean according to 83/467/EEC criteria of July 29 th, 1983

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria