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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 249-109-7 | CAS number: 28629-66-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to guideline. Restriction due to testing not performed under GLP but data are of sufficient quality.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR Section 1500.42-Federal Hazardous Substance Act Regulations,
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Zinc bis(O,O-diisooctyl) bis(dithiophosphate)
- EC Number:
- 249-109-7
- EC Name:
- Zinc bis(O,O-diisooctyl) bis(dithiophosphate)
- Cas Number:
- 28629-66-5
- Molecular formula:
- Too complex
- IUPAC Name:
- zinc bis(O,O-diisooctyl) bis(dithiophosphate)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown PA
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6-23.8.
- Humidity (%):40-45%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: 7 November 1993 – 28 November 1983
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted. - Duration of treatment / exposure:
- Test material was instilled into the conjunctival sac of one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
- Observation period (in vivo):
- The eyes were examined and graded for ocular reaction at 1, 2, 3, 4, 7, 14 and 21 days following instillation of test material into the eyes.
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.
- Time after start of exposure: not applicable.
SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Effects did not clear in 1/6 animals at 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 14
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Effects did not clear in 1/6 animals at 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Effects did not clear in 3/6 animals at 21 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the test material causes irreversible effects on the eye
- Executive summary:
In a primary eye irritation study, 0.1 ml of undiluted test substance was placed into one eye of each of the New Zealand White rabbits (6 animals). The test substance produced ocular irritation up to 21 days.
The test substance is classified as Category 1 in accordance with the classification system of GHS
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.
