2-methylbutan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register 28, No . 187, § 1500 .41, S . 27029, 1973

Principles of method if other than guideline:

Draize test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methylbutan-1-ol

EC Number:

205-289-9

EC Name:

2-methylbutan-1-ol

Cas Number:

137-32-6

Molecular formula:

C5H12O

IUPAC Name:

2-methylbutan-1-ol

Details on test material:

- Name of test material (as cited in study report): 2-methylbutanol-1
- Physical state: liquid
- Analytical purity: ca. 99%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Age at study initiation: young adult animals
- Weight at study initiation: 2.84 kg (mean weight at study end was 2.88 kg)
- Diet (e.g. ad libitum): Ssniff
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact/shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 hours without washing

Observation period:

8 days

Number of animals:

6 (5 male and 1 female animals)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
no applicable for the main study; test substance was was washed out (using a 50% lutrol solution) after 5 min or 2 hours in another experiment with 2 additional female animals

SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system:

Erythema:
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet-redness) to slight, eschar formation (injuries in depth)

Edema:
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approx. 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.4

Max. score:

4

Reversibility:

not fully reversible within: 8 d, necrosis

Remarks on result:

other: 24 h application

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.1

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: 24 h application

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: 2 h application

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.8

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: 2 h application

Other effects:

- Necrosis (some times spotted) was observed in 3/6 animals starting from the second day after the end of exposure and was persistent until the end of the observation period. All these observations were confirmed at necropsy.

Any other information on results incl. tables

Draize scores for intact/shaved application sites are presented below:

24 hour-treatment

Readings	Animal	Erythema	Edema	Additional findings
24 h	1	2	2
	2	2	2
	3	2	2
	4	2	2
	5	2	2
	6	2	2
48 h	1	2	2
	2	3	3
	3	3	3
	4	2	2
	5	2	2
	6	2	2
72 h	1	2	2
	2	4	2	sn
	3	4	2
	4	4	2	pn
	5	2	2	sn
	6	2	2
8d	1	2	2	d
	2	4	2	pn
	3	4	2	d, cr
	4	4	2	pn
	5	4	2	pn
	6	2	2	d
Mean 24 - 72 h	1	2.0	2.0
	2	3.0	2.3
	3	3.0	2.3
	4	2.7	2.0
	5	2.0	2.0
	6	2.0	2.0
mean		2.4	2.1

d: desquamation

cr: crusted skin

sn: slight necrosis

pn: parchment-like necrosis

5 min/ 2 hour-treatment:

		Exposure period: 5 min			Exposure period: 2 h
Readings	Animal	Erythema	Edema	Additional findings	Erythema	Edema	Additional findings
24 h	1	1	0		2	3
	2	2	0		2	3
48 h	1	1	0		2	2
	2	1	0		2	3
72 h	1	1	0		3	3
	2	1	0		3	3
8 d	1	0	0	d	4	2	cr
	2	0	0		2	2
Mean 24 - 72 h	1	1.0	0.0		2.7	2.7
	2	1.3	0.0		2.3	3.0
Mean		1.2	0.0		2.5	2.8

sn: slight necrosis

d: desquamation

cr: crusted skin

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance is considered to be irritating to the skin. based on the erythema/edema scores and the irreversibility of the observed effects up to the end of the 8-day observation period. Necrosis was only observed after 24hrs under occlusive conditions, but not after 2hrs. No skin permanent damage is expected, if the substance would be tested according to current guidline, i.e., 4h exposure under semiocclusive conditions.