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EC number: 923-144-4 | CAS number: 1182722-58-2
- 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 is not irritating to skin and eyes of rabbits.
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:
- February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline 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:
- yes
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: 3 males
- Source: Chr. FRED LEUSCHNER & CO, D-24601 Löhndorf/Post, Wankendorf
- Age at study initiation: approx. 5.5-8 months
- Weight at study initiation: 2.9-3.0 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: test item moistened with water
- Controls:
- other: the surrounding untreated skin served as control
- Amount / concentration applied:
- 0.5 g/patch and animal
4000 mg of the test compound were mixed with 4 ml water, 1000 mg of this paste were applied per animal - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, the patch was held in contact with the skin by means of a semi-occlusive dressing (no further information available)
REMOVAL OF TEST SUBSTANCE
- Washing: the patch was removed and the skin sites were evaluated (no further information available)
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- No systemic intolerance reactions were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
In an acute skin irritation study according to OECD TG 404 the test substance was applied for 4 hours to the shaved skin of 3 male rabbits. No rabbit showed any substance-related lesions at the examination time-points 1, 24, 48 and 72 hours after patch removal. No systemic intolerance reactions were observed.
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
- Study period:
- February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: 3 males
- Source: Chr. FRED LEUSCHNER & CO, D-24601 Löhndorf/Post, Wankendorf
- Age at study initiation: approx. 3 months
- Weight at study initiation: 1.9-2.1 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- single instillation of the test substance into the conjunctival sac; no rinsing of the eye at any time; 24 hours after administration the eyes were treated additionally with fluorescein and examined.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- 24 hrs fluorescein test: no pathological findings.
- Other effects:
- No systemic intolerance reactions were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
In an acute eye irritation study according to OECD TG 405 100 mg of test substance per animal was applied into the conjunctival sac of the right eye of 3 male rabbits. No rabbit showed any substance-related changes at the examination time-points 1, 24, 48 and 72 hours after the administration. The cornea, iris and conjunctivae were not affected by instillation of the test compound. No systemic intolerance reactions were observed.
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 an acute skin irritation study according to OECD TG 404 the test substance was applied for 4 hours to the shaved skin of 3 male rabbits. No rabbit showed any substance-related lesions at the examination time-points 1, 24, 48 and 72 hours after patch removal. No systemic intolerance reactions were observed.
Eye irritation
In an acute eye irritation study according to OECD TG 405 100 mg of test substance per animal was applied into the conjunctival sac of the right eye of 3 male rabbits. No rabbit showed any substance-related changes at the examination time-points 1, 24, 48 and 72 hours after the administration. The cornea, iris and conjunctivae were not affected by instillation of the test compound. No systemic intolerance reactions were observed.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.
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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