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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylvaleric acid
EC Number:
202-594-9
EC Name:
2-methylvaleric acid
Cas Number:
97-61-0
Molecular formula:
C6H12O2
IUPAC Name:
2-methylpentanoic acid
Details on test material:
- Name of test material (as cited in study report): alpha-methyl-pentansäure; test substance No. 84/281
- Physical state: liquid
- Analytical purity: data included in the raw data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: singly in stainless steel cages
- Diet;: KLIBA 341 diet, ca. 130 g/animal and day
- Water: tap water; ca. 250 mL/animal/day
- Acclimation period: at least 8 days

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:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amounts applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: porous bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with LUTROL and LUTROL:water 1:1
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and edema:
0 = none
1 = very slight
2 = moderate to severe
4 = severe

Results and discussion

Any other information on results incl. tables

 

Readings

Animal

Erythema

Edema

Symptoms

4 h

(within 30 to 60 minutes after patch removal)

1
2
3

1
2
2

0
1
1

 

24 h

1
2
3


2
2

0
0
0

 

48 h

1
2
3

3
4
2

1
0
0

 

72 h

1
2
3

3
4
2

1
0
0


N

8 d

1
2
3

1
4
1

0
0
0

S:SE/+
N:DE/+
S/+

Means per animal

1
2
3

2.7
3.3
2.0

0.7
0.0
0.0

 

Means

 

2.7

0.2

 


Abbreviations:
N = necroses; S = scaling; SE = severe; DE = deep; + = confirmed by incision of the skin

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2-methylvaleric acid is a CAT 1C skin corrosive
Executive summary:

In an OECD 404 guideline study, 2-methylvalericacid was applied to the intact rabbit’s skin (3 animals; 0.5 mL each) for 4 hours under a semi-occlusive dressing. Excess test material was washed at the end of the 4-hr exposure period. Skin reactions were scored within one hour after patch removal, and at days 1, 2, 3, and 8. Severe and persistent erythema was seen, whereas edema was minimal and reversible by day 8. Confirmed necroses and scabs were seen in all animals on day 8. The first necrosis was seen on day 3 (BASF, 1985).

 

The study is valid. The substance is a CAT 1C skin corrosive according to regulation EC/1272/2008.