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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
18 Dec 1981 - 27 Jan 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment (analytical purity of test substance not specified, readings at 4 and 48 hours only)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: D.O.T. Corrosivity (Skin Irritation on Rabbits,. 49 CFR 173.240)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not specified, readings at 4 and 48 h only
Principles of method if other than guideline:
An amount of 0.5 mL test substance was applied on a square surgical gauze patch measuring 2.5 cm x 2.5 cm and two single layers thick. The patch was applied on the clipped back of the animals and the entire trunk was wrapped with impermeous material such as rubberized cloth. After 4 hours, the patch was removed and the skin evaluated for corrosion immediately and after 48 h following application. Corrosion was considered to have resulted if the substance caused destruction or irreversible alteration of the tissue.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl laurate
EC Number:
203-911-3
EC Name:
Methyl laurate
Cas Number:
111-82-0
Molecular formula:
C13H26O2
IUPAC Name:
methyl laurate
Details on test material:
- Name of test material (as cited in study report): methyl dodecanonate
- Substance type: Fatty acid methyl ester
- Physical state: liquid, amber
- Analytical purity: not indicated, treated as 100% pure
- Storage condition of test material: room temperature, glass container

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Isaacs lab stock
- Weight at study initiation: > 2000 g
- Acclimation period: at least 7 days

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
48 hours
Reading time points: 4 and 48 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back skin, patch size: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean out of all 6 animals
Time point:
other: 4 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 48 h (end of observation time)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean out of all 6 animals
Time point:
other: 48 h
Score:
0.17
Max. score:
4
Reversibility:
not fully reversible within: 48 h (end of observation time)
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean out of all 6 animals
Time point:
other: 4 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean out of all 6 animals
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effect
Irritant / corrosive response data:
No corrosivity occurred. The test substance caused no edema but only slight erythema, that persists to the end of the observation time of 48 h.

Any other information on results incl. tables

Table 1: Individual erythema and edema scores

 

Erythema score at

Edema score at

Animal number

4h

48h

4h

48h

1

0

0

0

0

2

0

0

0

0

3

1

1

0

0

4

1

0

0

0

5

0

0

0

0

6

0

0

0

0

Mean scores

0.33

0.17

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: no classified
DSD: not classified