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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Feb - 07 Feb 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Lack of study details, occlusive exposure.

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:
lack of study details, occlusive exposure
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, mixed C8-10 and succinyl
EC Number:
294-620-0
EC Name:
Glycerides, mixed C8-10 and succinyl
Cas Number:
91744-56-8
Molecular formula:
Not applicable: Complex UVCB substance
IUPAC Name:
Glycerides, mixed C8-10 and succinyl
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: transparent liquid
- Analytical purity: no data
- Other: Density: 0.98 g/mL

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.044 kg (mean)

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Type of wrap if used: the treated skin was covered with a patch and held in place with an occlusive dressing.

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
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritant / corrosive response data:
No local irritating effects were observed during the study period.
Other effects:
No further local or systemic effects were reported.

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