Methyl stearate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 - 17 Apr 1992

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

Test material information

Constituent 1

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 stearate

Details on test material:

- Name of test material (as cited in study report): Stearinsäuremethylester
- Physical state: solid, white
- Analytical purity: Not indicated
- Storage condition of test material: RT, protected from light
- 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:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

21 days
Reading time points: 1, 24, 48, 72 h, 7, 14 and 21 days

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 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

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 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

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 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

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

At two animals slight erythema were observed 1 - 72 hours after the exposure, the third one showed partly moderate irritation effects. Seven days after the exposure all test animals showed eschar. Only in one rabbit a very slight edema persisted up to 21 days.

Other effects:

No further local or systemic effects were reported.

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
1	1	1	1	1	+ S	+	1
2	2	2	2	3	+ b S	+	0
3	1	1	1	1	+ S	+	0

 

Edema Score

Animal Number	1 h	1 day	2 days	3 days	7 days	14 days	21 days
1	0	0	0	0	+ S	+	0
2	1	2	2b	2 b	+ b S	+	0
3	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

Conclusions:

DSD: not classified
CLP: not classified