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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-044-5 | CAS number: 25791-96-2 1 - 6.5 moles propoxylated
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a guideline study. Study was conducted in accordance to GLP and OECD guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerol, propoxylated
- EC Number:
- 500-044-5
- EC Name:
- Glycerol, propoxylated
- Cas Number:
- 25791-96-2
- Molecular formula:
- (C3 H6 O)n (C3 H6 O)n (C3 H6 O)n C3 H8 O3 n=>1-<6.5 mol PO
- IUPAC Name:
- alpha, alpha’, alpha’’-1,2,3-propanetriyltris[w-hydroxypoly(oxy-methyl-1,2-ethanediyl)]
- Details on test material:
- Test substance: Propoxylated glycerol mw 300, pure colourless viscous liquid.
Purity: 99.98%, Contains 200 ppm antioxidant.
Batch No: 0133759A
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Daivid Percival Ltd, Moston, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.10 - 2.48
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as a control.
- Amount / concentration applied:
- Undiluted
Amount applied: 0.1 ml
Vehicle: None - Duration of treatment / exposure:
- Unspecified
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: not rinsed
REMOVAL OF TEST SUBSTANCE: Not Rinsed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24+48+72
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Redness grade 2 after 1 hr reversed after 24 hr.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Redness grade 2 after 1 hr reversed after 24 hr.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjuctival redness (grade 2) was observed in the eye of 2 rabbits at 1 hour post-instillation. All observed signs of irritation fully reversed within 24 hours.
- Other effects:
- Residual test material was observed around the treated eye of all rabbits 1 hour after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Propoxylated glycerol mw 300 was not an eye irritant according to EC criteria.
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.
