Glycerides, C16-18 and C18-unsatd. mono-

Skin irritation / corrosion

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:

08 - 12 Mar 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Lack of study details and test substance was only applied at 75% dilution. No details on analytical purity of the substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of study details; only 75% dilution of the test substance applied; no details on analytical purity of the substance

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Stearic acid, monoester with glycerol

EC Number:

250-705-4

EC Name:

Stearic acid, monoester with glycerol

Cas Number:

31566-31-1

Molecular formula:

C21H42O4

IUPAC Name:

2-hydroxy-1-(hydroxymethyl)ethyl stearate

Details on test material:

- Name of test material (as cited in study report): Stearate de Glycerol
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: 1412F

Test animals

Species:

rabbit

Strain:

other: New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.163 kg (mean)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

other: vaseline

Controls:

other: 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
- Concentration (if solution): 75% (w/v) (5 g of the test substance was mixed with 3.2 mL vaseline to a final volume of 6.7 mL)

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin was cleaned with absorbent paper soaked with distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

1 h post-application: slight erythema was observed in one animal. No edema and no further skin reactions were noted in any animal.
24-72 h post applicaion: no skin reactions were observed in any animal.

Other effects:

No further local or systemic effects were noted.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified