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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:
weight of evidence
Study period:
12 Jun 1991 - 15 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Comparable to guideline study with acceptable restrictions. Analytical purity of test substance not specified, no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not specified, no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline.
Qualifier:
according to guideline
Guideline:
other: FHSA (Federal Hazardous Substances Control Act), 16 CFR 1500.41
Deviations:
yes
Remarks:
25 instead of 24 h exposure.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene distearate
EC Number:
211-014-3
EC Name:
Ethylene distearate
Cas Number:
627-83-8
Molecular formula:
C38H74O4
IUPAC Name:
ethane-1,2-diyl dioctadecanoate
Details on test material:
- Test MateriaL: ethane-1,2-diyl dioctadecanoate
- Lot/batch No.: Lot #12051

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet: pelleted, Purina Rabbit Chow , ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21




Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
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 (volume or weight with unit): 0.5 g
- concentration: undiluted and not moistened


Duration of treatment / exposure:
25 h
Observation period:
72 h
Reading time points: 25 and 72 h
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² (see study report)
- Type of wrap if used: adhesive-backed gauze patches secured in place with an elastic wrapping.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped clean of any residual test material
- Time after start of exposure: 25 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Intact skin:
No erythema or edema was observed in any animal during the study period.
Abraded skin:
After 25 h slight erythema formation was observed in 2/6 animals being fully reversible within 72 h.
No edema formation was observed in any animal during the study period.
Other effects:
All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Intact skin: No erythema or edema was observed in any animal during the study period.
Abraded skin: After 25 h slight erythema formation was observed in 2/6 animals being fully reversible within 72 h.
No edema formation was observed in any animal during the study period.
All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
The test substance is determined to be not skin irritating.