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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 235-911-4 | CAS number: 13040-19-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC-guideline 84/449/EEC, 1984-09-19
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zinc diricinoleate
- EC Number:
- 235-911-4
- EC Name:
- Zinc diricinoleate
- Cas Number:
- 13040-19-2
- Molecular formula:
- C18H34O3.1/2Zn
- IUPAC Name:
- zinc bis(12-hydroxyoctadec-9-enoate)
- Reference substance name:
- 9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
- IUPAC Name:
- 9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
- Reference substance name:
- zinc ricinoleate
- IUPAC Name:
- zinc ricinoleate
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde
- Age at study initiation: -
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: single caging
- Diet (e.g. ad libitum): Sniff, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +- 2
- Humidity (%): 50-85
- Air changes (per hr):-
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g, the test substance was applied undiluted
- Duration of treatment / exposure:
- single application to the left eye, no washing
- Observation period (in vivo):
- 1h, 24h, 48h, 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 0.1 g of the test material was placed into the conjunctival sac of the left eye while the right eye served as a control. Readings of ocular reactions were made 1h, 24h, 48h and 72h after treatment. Beside this the eyes were examined for potential eye lesions 24h and 72h p.a. by means of 1 % fluorescein dilution (1 drop/eye).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: individual scoring according to Draize
- Basis:
- mean
- Remarks:
- all parameter for all animal
- Time point:
- other: 1 h
- Score:
- 0.71
- Max. score:
- 52
- Reversibility:
- fully reversible
- Irritation parameter:
- other: individual scoring according to Draize
- Basis:
- mean
- Remarks:
- all parameter for all animal
- Time point:
- other: 24 h
- Score:
- 0.25
- Max. score:
- 52
- Reversibility:
- fully reversible
- Irritation parameter:
- other: indicidual scoring according to Draize
- Basis:
- mean
- Remarks:
- all parameter for all animal
- Time point:
- other: 48 h, 72 h
- Score:
- 0
- Max. score:
- 52
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slight to moderate irritation of the conjunctiva occured within 24h after treatment wich was fully reversible within further 24 h.
Cornea and iris remained uneffected.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Grillocin PY 88 is not irritating to eyes.
- Executive summary:
The test substance is a fine white powder. The potential to cause damage to the conjunctivae, iris and cornea was assessed by single application of the test substance into the lower conjunctival sac of the eyes of six rabbits, strain New Zealand White, according to the OECD Guideline for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion”. Ocular reactions were assessed 1, 24, 48, and 72 hours after application of the test substance. At 24 h and 72 h p.a. the eyes of all animals were further examined with fluorescein to look for cornea damage. All six animals showed slight to moderate ocular reaction 1h and 24h after application of the test substance . 48h after application all animals were without any sign of ocular irritation. Cornea and iris remained uneffected. The test substance is valuated as not irritating to eyes.
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.
