Butan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, according to accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

-reliability scoring based on 2002 guideline

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butan-2-ol

EC Number:

201-158-5

EC Name:

Butan-2-ol

Cas Number:

78-92-2

Molecular formula:

C4H10O

IUPAC Name:

butan-2-ol

Details on test material:

- Name of test material (as cited in study report): Secondary Butyl Alcohol
- Physical state: colourless, clear liquid
- Analytical purity: 99.5%
- Expiration date of the lot/batch: one calendar month from the date of issue
- Lot/batch No.: Indent 9200/9530
- Stability under test conditions: Test substance was judged to have been stable for the duration of this study.
- Storage condition of test material: Following its arrival in compound control this test substance was stored in the dark at ambient temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 4 to 9 months old
- Weight at study initiation: 4440 to 4940 g (males) and 4100 to 4982 g (females)
- Housing: Housed individually
- Diet (e.g. ad libitum): Food (standard rabbit diet, S.Q.C., Special Diet Services Ltd., Essex), ad libitum
- Water (e.g. ad libitum): Filtered but untreated water from the public supply (whether or not water was administered ad libitum was not reported).
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: dorsal hair between the shoulders and hindquarters was closely shorn

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 animals/sex

Details on study design:

TEST SITE
- Area of exposure: dorsal hair between the shoulders and hindquarters
- % coverage: 2 cm x 2 cm
- Type of wrap if used: The patch and surrounding skin was covered by a single layer of gauze and held in place by means of an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated skin was not washed.
- Time after start of exposure: After 4 hours, the wrapping and patch were removed.

SCORING SYSTEM: The test site was examined and scored for erythema and oedema on a graded scale of 0 to 4 using the criteria given below. Observations were made at 30 minutes after the removal of the patch (i.e. approximately 4 hours after application) and at 24, 48, and 72 hours, and 7 days after application. The mean score of each rabbit at each observation time and the group mean 24, 48, and 72 hours were calculated.

Erythema scale:
No erythema 0
Very slight erythema (perceptible, area not defined) 1
Well defined erythema (pale red, area well defined) 2
Moderate to severe erythema (bright red, area well defined) 3
Severe erythema (beet or crimson red) 4

Oedema scale:
No oedema 0
Very slight oedema (perceptible, edges of area not defined) 1
Slight oedema (edges of area defined by raising) 2
Moderate oedema (area well defined, raised I mm) 3
Severe oedema (area raised more than 1 mm, extends beyond exposure area) 4

Injury in depth:
Escharosis, necrosis 8
A score of 8 is equivalent to scoring 4 for erythema and 4 for oedema.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 h, 24h, 48h, 72 h, and 7 days

Score:

0

Max. score:

4

Remarks on result:

other: All individual scores were 0 at all time-points indicated.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 h, 24h, 48h, 72 h, and 7 days

Score:

0

Max. score:

4

Remarks on result:

other: All individual scores were 0 at all time-points indicated.

Irritant / corrosive response data:

There were no skin reactions following the application of undiluted secondary butyl alcohol to rabbit skin for 4 hours. The test material is therefore not a skin irritant in rabbits.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: other: CLP (EC 1272/2008)