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EC number: 457-320-2 | 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
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- 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
- Toxic effects on livestock and pets
- Additional toxicological data
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, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Substance type: technical product
- Physical state: red viscous liquid
- Expiration date of the lot/batch: April 2007
- Storage condition of test material: Room temperature
- Other: pH of 5 of a 10% mixture of test substance in water
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: 13-14 weeks
- Weight at study initiation: 2.5-2.85 kg
- Housing: Individually housed in suspended stainless steel and wire mesh cages with absorbent paper below
- Diet (e.g. ad libitum): PMI certified rabbit diet 5322. The amount of feed administered to the animals was limited on a daily basis. The animals received new feed each day and the old feed, if any, was discarded.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29 May 2002 To: 10 June 2002
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 - Duration of treatment / exposure:
- The upper and lower lids were gently held together for approximately 1 second to prevent loss of the substance, and the treated eyes of the three animals remained unwashed
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
Draize standard eye irritation grading scale
TOOL USED TO ASSESS SCORE: fluorescein dye under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Exposure to 0.1 ml elicited conjunctival responses in all animals. Redness of Grade 1 was evident for all animals at the 1 h evaluation, which had increased to Grade 2 in two animals at 24 h. Redness decreased slightly at the 48 and 72 h evaluations, when two animals had redness of Grade 1 and one animal Grade 2. No redness was observed at day 7. Chemosis of Grade 1 was evident for one animal and chemosis of Grade 2 was evident for two animals at 24 h. Chemosis of Grade 1 was evident for two animals at the 48 h evaluation. White discharge of Grade 2 or 3 was evident for two animals at 24 h. Signs of conjunctival irritation were not evident at day 7. No necrosis or ulceration of the conjuctiva or nictitating membranes was seen.
Signs of irritation of the iris were not evident.
Corneal reponses were evident for two animals during the study. Corneal opacity of Grade 1 was evident for one animal at the 24 and 48 h evaluations. Dye retention (Grade 1 or 2) was evident for two animals at the 24 h and 48 h observations, and in one of these animals at 72 h. Stippling (area of pinpoint roughening) was observed in the eyes of two animals at the 72 h evaluation only. Corneal responses were not evident by day 7.
All changes were fully reversible within 7 days - Other effects:
- All animals survived to study termination and were free of clinical signs during the study
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study conducted according to OECD guideline 407, instillation of undiluted substance (0.1 ml) into the conjuctival sac of one eye of each of three rabbits (unwashed) caused moderate (but reversible) irritation to the conjuctiva, no irritation to the iris, and mild (but reversible) irritation to the cornea. In accordance with the EU CLP Regulation, the substance does not require classification as an eye irritant.
- Executive summary:
In a GLP study conducted according to OECD guideline 405, undiluted EC# 457-320-2 test substance (0.1 ml) was instilled into the conjuctival sac of the right eye of three New Zealand White rabbits. The upper and lower lids were gently held together for approximately one second to prevent loss of the test material, and the eyes of the three animals remained unwashed. The untreated eye served as the control. Signs of ocular irritation (using the Draize scoring method) were assessed at 1, 24, 48 and 72 h post-instillation, and on days 7 and 10.
Conjuctival responses (redness, chemosis and discharge) were elicited in all three animals (Grades 1 to 3) at 1, 24, 48 and/or 72 h timepoints, but no signs of conjuctival irritation were observed by day 7. No signs of irritation to the iris was observed throughout the study. Corneal responses (opacity, dye retention and stippling) were seen in two animals (Grades 1 or 2) at 24, 48 and/or 72 h observation periods, but no signs of corneal irritation were seen at day 7. All animals survived and were free of clinical signs during the study.
In conclusion, instillation of the substance (0.1 ml) into the conjuctival sac of one eye of each of three rabbits caused moderate but reversible irritation to the conjuctiva, no irritation to the iris, and mild but reversible irritation to the cornea. In accordance with EU CLP regulations, the substance would not require classification as an eye irritant.
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.
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