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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1992-04-07 to 1992-04-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test material not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl stearate
EC Number:
203-990-4
EC Name:
Methyl stearate
Cas Number:
112-61-8
Molecular formula:
C19H38O2
IUPAC Name:
methyl octadecanoate
Details on test material:
- Name of test material (as cited in study report): Stearinsäuremethylester
- Substance type: Stearic acid methyl ester
- Physical state: solid, white
- Analytical purity: Not indicated
- Storage condition of test material: RT, protected from light
- Impurities (identity and concentrations): not specified
- Expiration date: 17.09.1992

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation: approx 14 months
- Weight at study initiation: approx. 2320 g
- Diet: ad libitum (Ssniff rabbit diet K 4)
- Water: ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
1h, 24h, 48h, 72h, 7d, 14d and 21 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal skin, 6 cm²
- Type of wrap if used: air- and vapour permeable moisted gauze-patch fixed with hypoallergenic adhesive gauze-bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes. After exposure the skin was cleaned from the residual test substance.

SCORING SYSTEM: According to the council directive 84/449/EEC (Draize)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1319
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: Eschar formation observed at day 7
Irritation parameter:
erythema score
Basis:
animal: 1320
Time point:
other: average 24, 48 and 72h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 21 d
Remarks on result:
other: Eschar formation observed at day 7
Irritation parameter:
erythema score
Basis:
animal: 1321
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 d
Remarks on result:
other: Eschar formation observed at day 7
Irritation parameter:
edema score
Basis:
animal: 1319
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal: 1320
Time point:
other: average 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
edema score
Basis:
animal: 1321
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Erythema score

Animal Number

1 h

1 day

2 days

3 days

7 days

14 days

21 days 

1305

1

1

1

1

+ S

 +

1

1322

2

2

2

3

+ b S

 +

0

1324

1

1

1

1

+ S

 +

0

 

Edema Score

Animal Number

1 h

1 day

2 days

3 days

7 days

14 days

21 days 

1305

0

0

0

0

+ S

 +

0

1322

1

2

2b

2 b

+ b S

 +

0

1324

0

0

0

0

+ S

 +

0

+ = irreversible

S = Eschar

b = brownish discolouration

The test substance caused moderate irritation to all animals that persisted as slight erythema in one animal after the observation time of 21 days. According to DSD and CLP no classification for skin irritation is required.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU