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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 293-215-6 | CAS number: 91052-54-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 May - 27 May 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. Lack of details on test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- lack of details on test material
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 mono-, di- and tri-
- EC Number:
- 293-215-6
- EC Name:
- Glycerides, C16-18 mono-, di- and tri-
- Cas Number:
- 91052-54-9
- Molecular formula:
- C19H38O4; C21H42O4; C35H68O5; C39H76O5; C51H98O6; C57H110O6
- IUPAC Name:
- Glycerides, C16-18 mono-, di- and tri-
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.42-3.02 kg
- Housing: animals were individually housed in suspended metal cages.
- Diet: Rabbit Diet (Preston Farmers Ltd., New Leake, Boston, Lincolnshire, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19
- Humidity (%): 65-75
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL (as measured by gently compacting the required volume into an adapted syringe), which was found to weigh ca. 0.072 g. - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 1 male and 5 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 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:
- mean
- Remarks:
- out of all 6 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:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 2 animals scored 1 at 24 h; 4 animals scored 0 at 24-72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 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:
- 1 h post-instillation: slight iritis was observed in 2/6 animals, being fully reversible at the 24 h reading. Slight and moderate conjunctival redness was observed in 1 and 5/6 animals, respectively. Effects were fully reversible at the 24 h reading in 4/6 animals.Very slight and slight swelling was observed in 3 and 3/6 rabbits, respectively, the effects being fully reversible at the 24 h reading. All animals showed slight discharge at this, but not at the following reading time points.
24 h post-instillation: slight conjunctival redness was observed in 2/6 animals. Effects were fully reversible after 24 h (48 h post-instillation).
48-72 h post-instillation: no eye effects were noted in any animal. - Other effects:
- No further local or systemic effects were reported.
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.
