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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
12 Jun 1991 - 15 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. No experimental 48 h reading performed and 25 h exposure and occlusive dressing according to former guideline, analytical purity of test substance not clearly specified.
Justification for type of information:
The Glycol ester category covers esters of an aliphatic diol (ethylene glycol (EG), propylene glycol (PG) or 1,3-butyleneglycol (1,3-BG)) and one or two carboxylic fatty acid chains. The fatty acid chains comprise carbon chain lengths ranging from C6 to C18, mainly saturated but also mono unsaturated C16 and C18, branched C18 and epoxidized C18.
 
The available data allows for an accurate hazard and risk assessment of the category and the category concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus, where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).

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:
no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline, analytical purity of test substance not clearly specified.
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:
- Name of test material (as cited in study report): only trade name given
- Physical state: white powdered solid
- Analytical purity: no data
- Lot/batch No.: Lot #12735

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:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as controls
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 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
reading 25h
Irritation parameter:
erythema score
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
reading 25h
Irritation parameter:
edema score
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
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.
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

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