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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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