Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 613-333-7 | CAS number: 63705-03-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Lack of data on test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack of data on test substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-dihydroxypropan-2-yl 16-methylheptadecanoate; 2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propyl 16-methylheptadecanoate; 2-hydroxy-3-{2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propoxy}propyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl hexadecanoate
- EC Number:
- 613-333-7
- Cas Number:
- 63705-03-3
- Molecular formula:
- Unspecified
- IUPAC Name:
- 1,3-dihydroxypropan-2-yl 16-methylheptadecanoate; 2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propyl 16-methylheptadecanoate; 2-hydroxy-3-{2-hydroxy-3-[(16-methylheptadecanoyl)oxy]propoxy}propyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl 16-methylheptadecanoate; 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl hexadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Triglycerindiisostearat
- Physical state: liquid
- Appearance: yellow liquid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.5 kg
- Housing: The animals were single housed in rabbit cages.
- Diet: Altromin 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12
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 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 d
Reading time points: 1, 6, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.08
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- other: mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/4 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
