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EC number: 432-820-3 | CAS number: -
- 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
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Stability: thermal, sunlight, metals
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- Dissociation constant
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- Additional physico-chemical information
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- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data
![](https://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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 November 2000 to 03 December 2000
- 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 relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: February 28th 2000 Date of signature: April 26th 2000
Test material
- Details on test material:
- Sponsor's identification :S178207
Description : white powder
Batch number : SBT-5-0254
Date received : 08 November 2000
Storage conditions :room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: animals were individually housed in suspended metal cages
- Diet: ad libitum - STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: e.g. ad libitum - mains drinking water
- Acclimation period: acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES: From: Day of dosing (Day 0) To: Day of sacrifice (Day 7)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material, which was found to weigh approximately 35 mg (as measured by gently compacting the required volume into an adapted syringe)
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated in report
- Time after start of exposure: not stated in report
SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49
TOOL USED TO ASSESS SCORE:standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal: 145 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal: 178 Female
- Time point:
- other: Mean of 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal: 179 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 145 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 178 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 179 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 145 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed at 24, 48 and 72 hours
- Remarks on result:
- other: Score of 1 at 1 hour, fully reversed at 24 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 178 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed at 24, 48 and 72 hours
- Remarks on result:
- other: Score of 1 at 1 hour, fully reversed at 24 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 179 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed at 24, 48 and 72 hours
- Remarks on result:
- other: Score of 1 at 1 hour, fully reversed at 24 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 145 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- chemosis score
- Basis:
- animal: 178 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- chemosis score
- Basis:
- animal: 179 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- Very slight conjunctival irritation was noted in all treated eyes at the 1-hour observation. All treated eyes appeared normal at the 24-hour observation.
- Other effects:
- None noted
Any other information on results incl. tables
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 February 1987)
§ Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)
Result. A single application of the test material to the non-irrigated eye of three rabbits produced very slight conjunctival irritation in all treated eyes at the 1-hour observation. No other ocular reactions were noted during the study.
Conclusion. The test material produced a maximum group mean score of 2.0 and was classified as practically non-irritating (Class 2 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.
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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