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EC number: 221-573-5 | CAS number: 3147-75-9
- 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
Endpoint summary
Administrative data
Description of key information
The test substance did not cause skin irritation on the rabbit skin. Neither erythema nor edema were evident. No effects in the rabbit eye caused by the substance were evident, either. (reliability score: 2)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity, occlusive conditions, 24 h exposure)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation, occlusive treatment, 24 h exposure, no scoring at 48 h))
- Principles of method if other than guideline:
- 6 rabbits were treated with 0.5 g of the test substance, prepared as paste with diethyl succinate, for 24 h under occlusive conditions. The test sites were shaved before treatment. The test substance was applied to intact as well as to abraded skin. Scoring was recorded 24 h and 72 h after application (Draize Test).
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: diethyl succinate
- Controls:
- other: untreated site served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- no data
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: no data
- Type of wrap if used: impervious patch
REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 24 h
SCORING SYSTEM: according to the Draize Scoring System - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact and abraded skin
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation, no information on observation period)
- Principles of method if other than guideline:
- 0.1 g of the unchanged test substance was introduced into the conjunctival sac of 6 rabbits. Scoring was recorded 24 h, 48 h and 72 h after application (Draize Test).
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye served as control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- one single application
- Observation period (in vivo):
- no data
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no data
SCORING SYSTEM: according to the Draize Scoring System
(no chemosis scores were documented) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Other effects:
- Chemosis score was not taken, but was normally included in the conjunctivae score.
Furthermore, the following information was given: No obvious swelling of the conjunctivae excluding cornea and iris with partial eversion of the lids was seen. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
In a primary dermal irritation study, performed using a method identical to that described in the Federal Register, 38, No. 187 § 1500.41, 0.5 g of the test substance (no data on purity) was applied under occlusive conditions to the intact and abraded skin of 6 Albino rabbits. Treatment was terminated 24 hours following application and the animals were observed afterwards (no data on duration of observation period). Irritation was scored according to the Draize method 24 and 72 hours after application.
Average scores per animal (24 h – 72 h) were 0 (maximal score = 4). No signs of skin irritation were evident by the end of the observation period.
Results from the abraded skin are not included in the final judgement for skin irritation of the test substance because of its lack of scientific justification and gross deviation from todays acceptable standardized procedures for the appraisal of skin irritation. In this study, the test substance is not a skin irritant.
This study is suitable for assessment of dermal irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline. The conditions are even harsher (occlusive, extended exposure) than that described by the actual OECD guideline.
Eye irritation
The eye irritation potential of the test substance (no data on purity) was determined in a procedure identical to the procedure described in the Federal register 38, No. 187 § 1500.42, 0.1 g of the test substance was applied to the conjunctival sac of the left eye of each of 6 Albino rabbits. The other eye remained untreated and served as control. Irritation was recorded after 24, 48 and 72 hours. Appraisal of eye irritation was performed according to the method of Draize. Average Draize scores (24, 48 and 72 hours) were calculated per animal for corneal opacity, iritis, conjunctivae redness and chemosis. No indication for eye irritation was seen in any animal. All scored parameters in the 6 animals were 0. In this study, the test substance is not an eye irritant.
This study is suitable for assessment of eye irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline.
Justification for classification or non-classification
Dangerous substance Directive (67/548/EEC)
The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of skin irritants of Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, classification for skin and eye irritation is not warranted.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013, classification for skin and eye irritation is not warranted.
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