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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 614-264-5 | CAS number: 68081-77-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 10 July 2007 to 6 August 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sponsor's ID: AL305B
Lot No.: TS07003
Physical description: clear, colourless liquid
Analytical purity: 100%
Expiry date: 01 March 2008
Storage: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, Tennessee
- Age at study initiation: approximately 13 weeks
- Weight at study initiation: 2.9-3.1 kg
- Housing: suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Chow #5322 (PMI Nutrition International) ad libitium
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 53-69
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 31 July 2007 To: 6 August 2007
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): As received - Observation period (in vivo):
- 96 hours
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- The mean 24, 48 and 72-hour scores for corneal opactiy, iritis, conjunctive redness and cojunctive chemosis were calculated. The 24-hour mean ocular irritation score was also calculated according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Exposure to the test substance produced conjunctivitis (redness and/or discharge) in 3/3 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in 3/3 test eyes by the 24-hour scoring interval. Hair loss around the test eye was noted in 1/3 test eyes during the study. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Not irritating to eyes
- Executive summary:
The potential irritant and/or corrosive effects of AL305B were evaluated in the eyes of New Zealand White rabbits. Each of three rabbits received a 0.1 mL dose of the test substance in the conjunctival sac of the right eye. The left eye remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 96 hours following dosing.
Exposure to the test substance produced conjunctivitis in 3/3 test eyets at the 1 -hour scoring interval. The conjunctival irritation resolved completely in 3/3 test eyes by the 24 -hour scoring interval. Based on the results of this study, the mean 24 -hour Draize eye irritation score for Al305B was 0.00/110.
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.
