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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
Remarks on result:
other: 24 h application
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
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
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 5/6 animals starting from the second day (from day 3 the 2 animals of the 2-hour exposure group) after exposure and was persistent (with gain in entensity) at the end of the observation period. All these observations were confirmed at necropsy (crust formation). Irritant responses were generally more intense on abraded application sites

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 sn
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 sn, 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   4 3  
2 1 0   3 3 sn
8 d 1 0 0 d 4 2 cr
2 0 0   2 2 sn, d
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:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance has to be considered as irritating according to the EU (R38) or to GHS (Cat. 2), based on the erythema/edema scores and the irreversibility of the observed effects up to the end of the 8-day observation period.