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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Not classified for skin irritation or corrosion, or for eye irritation
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:
- data from handbook or collection of data
- Justification for type of information:
- Judged to be scientifically reliable and appropriate for risk assessment by the Expert Panel of dermatologists and scientists at the Cosmetics Ingredient Review, Washington, DC., USA.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.41
- Version / remarks:
- U.S. Federal Hazardous Substances Act
- Principles of method if other than guideline:
- Similar to OECD 404 but occlusive exposure to the test material for 24 h. Observation period is 14 days.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: albino, likely New Zealand white
- Details on test animals or test system and environmental conditions:
- Mean body weight for one group was 2.29 kg (intact) and the other was 2.81 kg (abraded group)
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact skin and abraded in separate groups
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 2000 mg/kg bw
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 d
- Number of animals:
- 10 total, 5 for intact skin exposure, 5 for abraded skin exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal: 2/5
- Remarks:
- at abraded site
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1/2 with erythema persisted to day10; erythema was not related to test material application
- Irritation parameter:
- other: Desquamation
- Basis:
- other: 3/5
- Time point:
- other: day 5-6
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: very slight to slight desquamation
- Irritation parameter:
- other: desquamation
- Remarks:
- in Intact skin group
- Basis:
- other: 2/5
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: very slight to slight desquamation
- Irritant / corrosive response data:
- No erythema or edema effects were seen at intact skin sites. No edema was observed in any animal during the study.
Of the animals with abraded skin which displayed erythema, the extent was judged to be very mild (score 1 of 4). This resolved in one animal by day 3, but persisted to day 10 in the second. This was judeged by the study director to be unrelated to ATHC administration.
Desquamation, very slight to slight, was observed in five rabbits (three abraded skin, and two intact skin). The onset was day 5 or 6, and was cleared by day 10. At intact sites, desquamation was observed on day 6 or 7 only. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was applied to the skin of rabbits in a very aggressive skin irritation protocol (US FHSA, 16 CFR 1500.41). The findings of no effects in intact skin does not meet the criteria for classification under the CLP regulation. The substance is not classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Predates Regulation EC No. 863/2016.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Justification for type of information:
- Guideline study under GLP, prior to passage of Regulation EC No. 863/2016.
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. FHSA, 16 CFR 1500.42
- Version / remarks:
- Federal Hazardous Substances Act
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals used
- Principles of method if other than guideline:
- Similar to OECD 405
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Purity 97%
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 72 h from the beginning of the exposure
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not generally done, but any eyes may be washed with sodium chloride solution U.S.P or equivalent after the 24 h reading
- Time after start of exposure: not before 24 h
SCORING SYSTEM: Draize, et al., 1944, as listed in 16 CFR 1500.42.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 8
- Max. score:
- 110
- Irritation parameter:
- other: conjunctival redness
- Basis:
- other: 4/6 animals
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight reddening of the conjunctivae were noted in 4 of 6 rabbits within 6 hours of instillation. In three rabbits, the reddening persisted through 24 h, but had cleared by 48 h. According to the study directors, a positive ocular irritation reaction was not observed in any of the rabbits tested. None of the following changes was observed: chemosis, iritis or corneal opacity or denudation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was not irritating in a guideline in vivo study, according to the U.S. FHSA. Classification is not indicated according to Regulation EC No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
For evaluation of skin irritation, two studies are available which use a protocol with a harsher exposure scheme than that required by OECD 404 for classification and labelling (Regulation EC No. 1272/2008). The primary differences are an occlusive exposure (rather than semi-occlusive), the abrasion of the skin at half the sites/half the animals, and a duration for 24 h (rather than 4 h). The findings of negligible transient effects in intact skin do not meet the criteria for classification under the CLP regulation.
In an ocular irritation study according to a US protocol similar to an OECD 405, the substance is not an eye irritant. Slight transient conjunctival redness was observed. No chemosis, discharge, iritis or corneal opacity were observed. This is consistent with a study on a structural analogue.
Justification for classification or non-classification
Older in vivo studies reporting negligible transient erythema effects in intact skin under extreme exposure conditions (occlusive, 24 hour, intact and abraded skin) are available for this test substance. Only very slight conjunctival redness was observed in a guideline eye irritation study. These data do not meet the criteria for classification for skin irritation under the Regulation EC No. 1272/2008. The substance is not classified.
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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