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EC number: 245-043-8 | CAS number: 22502-03-0
- 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
A study was carried out according to OECD Guideline 404 (skin irritation) on six NZW rabbits. The test was performed in 1980 as non-GLP-study. The substance was classified as non-irritant to skin.
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
- Study period:
- November 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline-study (non-GLP)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hylyne Rabbits Ltd., Commercial Rabbits, 78 Warring ton Road, Statham UK
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 2.97-3.20 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Standard Rabbit Diet, B.P. Nutrition (UK) Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): Tap water
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-22°C
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 14 hours artificial light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Portions of the test article (0.5 ml) were applied to 1 intact and 1 abraded site on each animal and covered with patches of gauze (25 mm x 25 mm).
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 6 animals
- Details on study design:
- Application of test article:
Twenty four hours prior to treatment, the back of each animal was clipped free of hair using veterinary clippers (Model A2, Oster,
Milwaukee, Wisconsin). The left side of the clipped area on each animal was left intact. The right side was abraded using a clipper head to penetrate the horny layer of the epidermis, but without causing bleeding or damage to the underlying dermis. Portions of the test article (0.5 ml) were applied to 1 intact and 1 abraded site on each animal and covered with patches of gauze (25 mm x 25 mm). A small plug of cotton wool weighing approximately 1 g was placed over the top of the pads to achieve uniform pressure over the whole treated surface. The pads were held in place by a strip of adhesive impermeable plaster, (Sleek, Smith and Nephew Ltd., Welwyn Garden City, Herts). - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score 1 observed in one animal after 4 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score 1 observed in two animals after 4 hours
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Two animals showed very slight erythema and one animal very slight oedema in both intact and abraded sites 4 hours after treatment. All skin reactions regressed and appeared normal at the 24 hour observation. A primary irritation index of 0.17 was obtained. The test article was classified as a mild skin irritant. P5098 did not produce a corrosive response.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was classified as non-irritant to skin.
- Executive summary:
A study was carried out according to OECD Guideline 404 (skin irritation) on six NZW rabbits. The test was performed in 1980 as non-GLP-study. Six albino rabbits were treated semi-occlusive with 0.5 g test item applied on a 25 x 25 mm gauze covered with patches. Observation times were 24, 48 and 72 hours after removal of the patch. Slight erythema and oedema were observed in two out of six animals, resulting in a primary irritation index of 0.2. The substance was classified as non-irritant to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Klimisch 2 study; test design according to OECD 404 (non-GLP)
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).
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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