Alcohols, C20-30 (even numbered)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

18/06/1997-21/06/1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to current OECD guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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:

Docosan-1-ol

EC Number:

211-546-6

EC Name:

Docosan-1-ol

Cas Number:

661-19-8

Molecular formula:

C22H46O

IUPAC Name:

docosan-1-ol

Details on test material:

- Name of test material (as cited in study report): Kalcol 220-80

- Physical state: white solid

- Storage condition of test material: ambient temperature (<25C) in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.81 - 3.15 kg
- Housing:individually housed in suspended metal cages
- Diet: STANRAB SQC Rabbit diet, ad libitum
- Water: mains water, ad libitum
- Acclimation period:minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 59-62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5g of test material was moistened with 0.5ml distilled water

Duration of treatment / exposure:

4 hour(s)

Observation period:

Ca. 1h, 24h, 48h, 72h after patch removal

Number of animals:

3F

Details on study design:

TEST SITE
- Area of exposure: shorn dorsal  surface of the skin,  2.5 x 2.5 cm
- Type of wrap if used: gauze patch secured in position with a strip of surgical adhesive tape, wrapped in an elastic corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4h


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24/48/72h

Score:

0

Max. score:

0

Reversibility:

other: n/a

Irritant / corrosive response data:

The test material produced a primary irritation index of 0.0. 

Other effects:

No evidence of skin irritation was noted during the study other than very slight  erythema at one test site at 1 hour after patch removal. All other scores  were 0.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Kalcol 220-80 is not a skin irritant when applied to rabbit skin undiluted in a 4 hour semi-occlusive exposure. Group mean 24+48+72 hours were 0.