Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Limited documentation, concentration and details on test substance not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation (type of dressing, treatment of skin prior to substance application), concentration of test substance not given, lack of details on test substance)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxyethyl stearate
EC Number:
203-886-9
EC Name:
2-hydroxyethyl stearate
Cas Number:
111-60-4
Molecular formula:
C20H40O3
IUPAC Name:
2-hydroxyethyl stearate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
Reading time points: 1, 24, 48 and 72 h
Observation period: 72 h
Number of animals:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
other: mean 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:
Slight local skin reactions visible as erythema graded with score 1 were observed in all test animals 1 hour after patch removal. 24 hrs after patch removal, slight erythema (grade 1) were still visible in 2/3 animals. The erythema were fully reversible 48 hrs after patch removal. Oedema were not observed in any test animal.
Other effects:
No other effects are reported.

Applicant's summary and conclusion

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