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EC number: 200-652-8 | CAS number: 67-43-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
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- Nanomaterial agglomeration / aggregation
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- Nanomaterial specific surface area
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No data on batch no. and composition. Basic data given: comparable to guidelines/standard
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- audited in-house
Test material
- Details on test material:
- Test material was used as recieved.
No data on composition or batch number.
Appearance: liquid
Date of receipt: 9 July 1984
Stored at ambient temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Morton Commercial Rabbits, Stanted, UK and Pemberley Rabbits, Cottenham, UK
- Age at study initiation: ca. 9-13 weeks
- Weight at study initiation: 2.0-2.8 kg
- Housing: individually in metal cahes with perforated floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes, but duration not indicated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19
- Humidity (%): 30-70
- Air changes (per hr): ca. 19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 6 To: 13 August 1984
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- singe application in one eye, gently held together for 1 second before releasing.
- Observation period (in vivo):
- up to 7 days.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated
SCORING SYSTEM:
CORNEA
Degree of density (most dense area used)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre) 1*
Easily discernible translucent areas, details of iris slightly obscured 2*
Nacrous areas, no details of iris visible, size of pupil barely discernible 3*
Opaque cornea, iris not discernible through the opacity 4*
IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection,
any or all of these or combination of any thereof, iris still reacting to light
(sluggish reaction is positive) 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) 2*
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected)l 1
Diffuse, crimson colour, indiviual vessels not easily discernible 2*
Diffuse, beefy red 3*
Chemosis (lids and/or nictitating membranes)
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half closed 3*
Swelling with lids more than half closed 4*
[Note: * interpreted as a positive effect.]
TOOL USED TO ASSESS SCORE: hand-held torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no effects were present
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable as no effects were present
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed.
Temporal mild conjunctival irritation was seen in all 3 animals; the eyes were normal 3 days after instillation. However, based on the scoring system, this was not considered to be a positive effect (see scoring system indicated above). - Other effects:
- No other effects were observed.
Any other information on results incl. tables
Summary for scoring of ocular lesions
Animal no. |
Effect |
Hour |
Days after instillation |
Result (+/-) |
||||
1 |
1 |
2 |
3 |
4 |
7 |
|||
786 |
Cornea Iris Redness Chemosis |
0 0 1 1 |
0 0 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
- |
794 |
Cornea Iris Redness Chemosis |
0 0 1 1 |
0 0 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
- |
853 |
Cornea Iris Redness Chemosis |
0 0 1 1 |
0 0 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
- |
Changes (redness and chemosis) were limited to the conjunctivae only
+ = positive result; - = negative result
Mean score cornea 24/48/72 h: 0 for all 3 animals
Mean score iris 24/48/72 h: 0 for all 3 animals
Mean score redness 24/48/72 h: 0.67 for all 3 animals
Mean score chemosis 24/48/72 h: 0.33 for all 3 animals
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of the test material into the rabbit eye did not elicit a positive response in any of the 3 treated animals according to OECD-GHS criteria.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used
followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion".
A single application of the test material to the eye of three rabbits produced minimal conjunctival irritation All treated eyes appeared normal 72 hours after treatment. The test material produced in each animal a maximum score of 1 on redness and also 1 on chemosis.
The test material did not meet the criteria for classification as irritant according to OECD-GHS labelling regulations. No symbol and risk
phrase are required.
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.
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