Registration Dossier
Registration Dossier
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EC number: 224-160-8 | CAS number: 4219-49-2
Toxicological information
Skin irritation / corrosion
Currently viewing:
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:
- 1 991
- 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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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