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Diss Factsheets
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EC number: 252-478-7 | CAS number: 35274-05-6
- 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
Information based on three separate in-vivo tests.
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:
- weight of evidence
- Study period:
- 1958
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in pre-GLP period but sufficient detail reported.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The irritation index is based on the Draize method in this study. Presently, this method is no longer used for determination of the degree of irritation.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- open
- Preparation of test site:
- abraded
- Vehicle:
- other: mineral oil
- Controls:
- not required
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 30 days
- Score:
- >= 0
- Reversibility:
- no data
- Other effects:
- no other effect
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No irritation.
- Executive summary:
The results show that all the animal treated showed a normal weight gain, sacrificed area showed normal healing, blood count showed no deviation from normal and the histological examination of the skin taken from the experimental area showed a normal picture.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no GLP but the method used was based on scientifically accepted method.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The method used was based on Draize, John H., Woodward, Geoffrey, and Calvery, Herbert 0., "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Ex. Ther. 82, 377, (1944).
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino New Zeland
- Details on test animals or test system and environmental conditions:
- Animals were received from Summit view farm, Belvidere, New Jersey. The animals are fed and watered ad libitum; with wayne animal feeds used exclusively. Text material were applied on intact and abraded skin and was covered with an impermeable occlussive wrapping. The wrapping were removed 24h following application.
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 24h
- Observation period:
- 24h & 72h
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Average of 24 and 72h
- Score:
- 2.9
- Other effects:
- no data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not a primary dermal irritant.
- Executive summary:
Calculation of the primary irritation index was not correctly performed in the report as the total score should be divided by the product of the number of animals and the number of time points. In this study this means that the total score of 2.90 should be divided by 12 resulting in a primary irritation index of 0.24. According to Draize, values less than 2 should be considered as potential for slight irritation. However 100% of the text material was applied to intact and abraded skin, covered with occlusive wrapping which was only removed after 24h.
In practical, this is not possible, since treatment is immediately given when one is exposed to text material (rarely 100%). Thus, one could say that the texting material has no irritation potential.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no GLP but the method used was based on scientifically accepted methods.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The method used was based on Draize, John H., Woodward, Geoffrey, and Calvery, Herbert 0., "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Ex. Ther. 82, 377, (1944).
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino New Zeland
- Details on test animals or test system and environmental conditions:
- Animals were received from Summit view farm, Belvidere, New Jersey. The animals are fed and watered ad libitum; with wayne animal feeds used exclusively. Text material were applied on intact and abraded skin and was covered with an impermeable occlussive wrapping. The wrapping were removed 24h following application.
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- other: corn oil
- Controls:
- not required
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 24h
- Observation period:
- 24h & 72h
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.25
- Max. score:
- 8
- Reversibility:
- fully reversible
- Other effects:
- no data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not a primary dermal irritant
- Executive summary:
The results show that the primary irritation index is 0.25 which means that the text material is rarely irritating to human under condition similar to rest. However 100% of the text material was applied to intact and abraded skin, covered with occlussive wrapping which was only removed after 24h.
In practical, this is not possible, since treatment is immediately given when one is exposed to text material (rarely 100%). Thus, one could say that the texting material has no irritation potential.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The studies used for both skin and eye irritation were based on weight of evidence. Though no guideline were used in the most of the studies but the test and the scoring were based on Draize method of standard scoring which is approved according to Guidiance on the application of GLP criteria.
Justification for classification or non-classification
The test material was not classified. Thus, non- irritant to both skin and eye.
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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