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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-859-9 | CAS number: 100-51-6
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: guideline study according OECD 405 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- Benzyl alcohol
- EC Number:
- 202-859-9
- EC Name:
- Benzyl alcohol
- Cas Number:
- 100-51-6
- Molecular formula:
- C7H8O
- IUPAC Name:
- phenylmethanol
- Details on test material:
- - Name of test material (as cited in study report): Benzylalkohol
- Purity: 99.99%
- Appearance: colourless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: albino rabbits, HC:NZW
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England, UK
- Age at study initiation: adult rabbits
- Weight at study initiation: 3.1-3.4 kg
- Housing: individually under standardized conventional conditions in stainless steel cages with perforated floors
- Diet: approx. 100-120 g/animal and day; feeding once per day in the morning
- Water: ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye of the respective animal served as control
- Amount / concentration applied:
- 100 µl (ca 104.5 µg)
- Duration of treatment / exposure:
- 24 hours (The treated eye was washed out 24 hours after instillation of the test compound)
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM:
as described by Draize
TOOL USED TO ASSESS SCORE:
hand-slit lamp, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d at the latest
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score: 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d at the latest
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: mean score: 0.7
- Irritant / corrosive response data:
- Exposure of the test substance to the eye resulted in irritant effects of the mucous membranes and the cornea. Being more pronounced immediately following administration signs persisted on day 14 in 2 animals but proved to be reversible after 3 weeks. According to the author these evidences indicate an irritant potential of the product to the eye.
- Other effects:
- With fluorescein slight and reversible epithelial effects in the cornea were seen.
Applicant's summary and conclusion
- Executive summary:
According to OECD TG 405, 3 rabbits received a dose of 100 µl/animal into the conjunctival sac of one eye of each rabbit (the untreated eye served as control). Eyes were washed out 24 hours after start of exposure. The total post exposure period was 21 days. Benzyl alcohol was irritating to the eyes of rabbits, but full recovery occurred within the 21 days observation period (Bayer AG 1990).
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.
