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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-486-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-04-07 to 1987-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented OECD 405 study.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Justification for the read-across from the introduced read-across supporting substance (CAS 67938 -21 -0) to the registration substance:
The introduced read-across supporting substance (CAS 67938-21-0) is structurally related to the registration substance. Both substances are fatty acid esters of polyglycerols, the only diffence being that the introduced read-across source substance (CAS 67938-21-0) is synthesized by using isostearic acid as fatty acid while the registration substance by using stearic acid.
Both substances are expected to undergo enzymatic hydrolysis resulting into the release of polyglyerols and the corresponding fatty acids (isostearic acid for the read-across supporting substance and the stearic acid for the registration substance. Isostearic acid as well as the stearic acid are well-investigated substances and occurs also endogenously. No difference in the eye irritation property can be reliably derived. - Reason / purpose for cross-reference:
- assessment report
- Interpretation of results:
- GHS criteria not met
- Executive summary:
No classification is warranted for the registration substance based on the read across data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Di(isooctadecanoic) acid, diester with oxydi(propanediol)
- EC Number:
- 267-821-6
- EC Name:
- Di(isooctadecanoic) acid, diester with oxydi(propanediol)
- Cas Number:
- 67938-21-0
- Molecular formula:
- C42H82O7
- IUPAC Name:
- di(isooctadecanoic) acid, diester with oxydi(propanediol)
- Reference substance name:
- Diglyceryl-diisostearate
- IUPAC Name:
- Diglyceryl-diisostearate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Synonyms: Diglycerinisostearat, Polyglycerinisostearat
- Physical state: liquid
- Analytical purity: n.a.
- Composition of test material, percentage of components: 100 % Diglycerinisostearat
- Purity test date: n.a.
- Lot/batch No.: n.a.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test material was tested for primary eye irritation in three New Zealand albino rabbits according to OECD test guideline 405. The animals had no ocular abnormalities. 0.1 mL of undiluted test substance was applied once to the conjunctival sac of the left eyes of three rabbits. The untreated eye served as a respective control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which corneal examination with fluorescein sodium took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours after instillation of test substance
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation appeared
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation appeared
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation appeared
- Irritant / corrosive response data:
- One hour after treatment the conjunctivae on one animal showed some definitely injected blood vessels as well as a swelling with partial eversion of lids. The other two animals showed blood vessels definitly injected. 24 hours after application some definitely hyperaemic blood vessels were still present in one animal. From 48 hours p.a. all signs of irritation were reversible.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results from this OECD 405 study technical grade of test substance is not irritating to eyes and thus not subject to labeling requirements.
- Executive summary:
The test material was tested for primary eye irritation in three New Zealand albino rabbits according to OECD test guideline 405. 0.1 mL of undiluted test substance was applied once to the conjunctival sac of the left eyes of three rabbits. The untreated eye served as a respective control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which corneal examination with fluorescein sodium took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. One hour after treatment the conjunctivae of one animal showed some definitely injected blood vessels as well as a swelling with partial eversion of lids. The other two animals showed blood vessels definitely injected. 24 hours after application some definitely hyperaemic blood vessels were still present in one animal. From 48 hours p.a. all signs of irritation were reversible.
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.
