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EC number: 217-992-8 | CAS number: 2033-24-1
- 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 substance was classified as non-irritant to skin and as irritant Cat.2 to eyes.
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:
- March 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: the study was performed before GLP- and OECD-testing guidelines were available and in force; therefore the study was considered to have Klimisch 2, however it provides enough information to assess the acute toxicity to rats after oral application
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute 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: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, UK
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 3.5 kg
- Diet (e.g. ad libitum): Food (Rabbit Pellets C, Spillers Agriculture Ltd., Old Change House, Canon Street, London)
- Water (e.g. ad libitum): Mains water was provided and dipensed from glass water bottles
- Acclimation period: 7 days
- Housing: caged individually in grid floor cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not controlled except that a lower limit of 14°C was automatically imposed
- Humidity (%): not controlled
- Air changes (per hr): fan controlled air circulation
- Photoperiod (hrs dark / hrs light): natural lighting supplemented with fluorescent lighting during working hours (06.00 - 20.00) - Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- The test article was moistened with water and applied as a paste. Portions of the test article (0.5 g) were applied.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4, 24, 48 and 72 hours after treatment
- Number of animals:
- 6 animals
- Details on study design:
- APPLICATION TEST ARTICLE:
Twenty-four hours prior to treatment, the back of each animal was clipped free of hair using veterinary clippers (Model A2, aster, Milwaukee, Wisconsin). One side of the clipped area on each animal was left intact. The other 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 g) 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 treatai surface. The pads were held in place by a strip of adhesive impermeable plaster, (Sleek, Smith and Nephew Ltd., Welwyn Garden City, Herts). An Elizabethan collar was placed around the neck of each animal to prevent removal of the wrapping. Four hours after treatment the wrappings and collars were removed.
SCORING SYSTEM:
According to Food and Drug Administration "Appraisal of the Safety of Chemicals in Focxls, Drugs and Cosmetics", 1959.) The scores for
erythema and oedema were used to calculate the primary irritation index of the test article - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72h
- Irritant / corrosive response data:
- ERYTHEMA:
5/6 animals showed a score of 0 over the observation period of 24-72h.
1/6 animal showed a score of 1 over the observation period of 24-72h. Not fully reversible within: 72h
OEDEMA:
5/6 animals showed a score of 0 over the observation period of 24-72h.
1/6 animal showed a score of 0.7 over the observation period of 24-72h. Not fully reversible within: 72h - Interpretation of results:
- slightly 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 equivalent or similar to OECD Guideline 404 (skin irritation) on six NZW rabbits. The test was performed in 1980 as GLP-study according to OECD 404. 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 one out of six animals, resulting in a primary irritation index of 0.4. The substance was classified as non-irritant to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Klimisch 2 study; test design equivalent or similar to OECD 401
Justification for selection of eye irritation endpoint:
No study available; however based on pH-value, chemical structure, handling experience and CLP-data from other companies, it needs to be assumed that the substance is moderately irritating to eyes.
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Based on the data available the substance the substance needs to be classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP) as follows:
CLP:
Warning
Eye irritation, Cat.2
DSD:
Irritant
R36
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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