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EC number: - | 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
- Study period:
- June 15, 1988 - June 29, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed similar to OECD 405 (1981) and according to GLP principles. However, as the observation period stopped on day 7, the reversibility could not be fully assessed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: modification of the Code of Federal Regulations 1500-42 (1985)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- the observation period of only 7 days instead of up to 21 days was not sufficient to evaluate the reversibility or irreversibility of the effects observed, and the ocular lesions were not scored 1 hour after installation
- GLP compliance:
- yes
Test material
- Test material form:
- other: aqueous solution
- Details on test material:
- - Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, USA
- Age at study initiation: no data (but reported to be young adults)
- Weight at study initiation: 2.30 - 2.62 kg
- Housing: suspended wire mesh cages
- Diet: Purina rabbit pellets (ad libitum)
- Water: ad libitum
- Acclimation period: minimum period of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 72 ± 5 degrees F (22.2 ± 5 °C)
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark/12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye served as the control
- Amount / concentration applied:
- TEST MATERIAL (applied as such)
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Not applicable (the eyes were not rinsed)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (2 females and 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not applicable
SCORING SYSTEM: similar to OECD 405
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- See section "Any other information on results incl. tables"
- Other effects:
- See section "Any other information on results incl. tables"
Any other information on results incl. tables
Animal number and sex |
Parameter |
Hours after instillation |
Days after instillation |
|||
24 |
48 |
72 |
4 |
7 |
||
7907 Male |
Cornea (opacity) |
1 |
1 |
0 |
0 |
0 |
Cornea (area) |
1 |
1 |
0 |
0 |
0 |
|
Iris |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae (redness) |
2 |
1 |
1 |
0 |
0 |
|
Conjunctivae (chemosis) |
2 |
1 |
1 |
0 |
0 |
|
Conjunctivae (discharge) |
2 |
1 |
0 |
0 |
0 |
|
7908 Female |
Cornea (opacity) |
2 |
2 |
2 |
2 |
2 |
Cornea (area) |
not scored |
|||||
Iris |
1 |
1 |
1 |
0 |
1 |
|
Conjunctivae (redness) |
3 |
3 |
2 |
1 |
2 |
|
Conjunctivae (chemosis) |
2 |
2 |
1 |
1 |
2 |
|
Conjunctivae (discharge) |
2 |
2 |
1 |
1 |
2 |
|
7909 Female |
Cornea (opacity) |
2 |
2 |
2 |
1 |
0 |
Cornea (area) |
2 |
2 |
1 |
1 |
0 |
|
Iris |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae (redness) |
2 |
2 |
1 |
1 |
0 |
|
Conjunctivae (chemosis) |
2 |
1 |
1 |
1 |
0 |
|
Conjunctivae (discharge) |
2 |
2 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, performed similar to OECD 405 (1981) and according to GLP principles, the substance (solid content 38-40%) is classified as causing serious eye damage (Category 1) according to the criteria of the CLP Regulation.
- Executive summary:
The substance was tested for acute ocular irritation in 2 females and 1 male New-Zealand White rabbits, similar to OECD 405 and according to GLP principles. The test material (solid content: 38-40%), was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of each animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed 24, 48, 72 hours and 4 and 7 days after the instillation. Grade 2 corneal opacity was observed in 2 animals at 24 hours, lasting up to 72 hours in 1 animal. It persisted in the other animal throughout the 7 day observation period. In this same animal, conjunctival redness (grade 1, 2 and 3), conjunctival chemosis (grade 1 and 2) and iris inflammation (grade 1) persisted also throughout the observation period. In the other 2 animals the effects (grade 1 and 2) reversed within the observation period. As reversibility could not be observed in 1 animal in this study, the substance should be classified according to Regulation EC 1272/2008 with category 1, H318 "Causes serious eye damage".
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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