Registration Dossier
Registration Dossier
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EC number: 224-160-8 | CAS number: 4219-49-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 05 Jun 1991 - 08 Jun 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Only 72 h observation period, 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).
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not clearly specified; observation period terminated at 72 h, although not fully reversible at that point
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA/CPSC: Federal Hazardous Substances Control Act, 16 CFR 1500.42
- 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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: ad libitum
- Water: ad libitum
- Acclimation period: 34 or 51 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.5
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 72 h
Reading time points: 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 48 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- The test substance has slight irritaing effects when instilled into rabbit eyes. At the end of the observation period slight hyperemia in 2 animals was left.
- Other effects:
- All animals appeared active and healthy. Apart from the eye irritation noted in Table 1, there were no signs of systemic toxicity, adverse pharmacologic effects or abnormal behavior.
Any other information on results incl. tables
Table1: Individual eye irritation scores
|
Average irritation score of 24, 48 and 72 h |
|||
Animal number |
Cornea |
Iris |
Conjunctiva |
Chemosis |
8797 |
0 |
0 |
1 |
0.33 |
8798 |
0 |
0 |
0.66 |
0 |
8799 |
0 |
0 |
1.33 |
0 |
8800 |
0 |
0 |
0.33 |
0 |
8801 |
0 |
0 |
1 |
0 |
8802 |
0 |
0 |
0.33 |
0 |
Mean |
0 |
0 |
0.775 |
0.055 |
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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