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EC number: 252-346-9 | CAS number: 35074-77-2
- 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
In a primary skin and eye irritation study, no skin or eye irritating effects were observed in six New Zealand rabbits. (BASF, 1970)
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:
- Dec. 1969 - Jan. 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study. Scientifically acceptable study report.
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances, Part 191, Section 10 and 11; FDA, Washington 1965
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum, Altromin K (ALTROMIN GmbH, Lage/Lippe))
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 60±3
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Concentrations: 2500 and 10000 mg/kg bw as 50% suspension. One positive control group was tested.
- Duration of treatment / exposure:
- Refer to observation period. Skin sites were not washed after 24 hours with the semiocclusive dressing.
- Observation period:
- 14 days
- Number of animals:
- 3 animals/sex/dose
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: rubber sleeve
SCORING SYSTEM: According to Draize et al. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation regarding erythema and edema were observed either on the intact or on the abraded skin.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study. Scientifically acceptable study report.
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances, Part 191, section 12, FDA, Washington 1965
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum, Altromin K (ALTROMIN GmbH, Lage/Lippe))
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 60±3
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- SIngle exposure. Eyes of the animals were not washed.
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Remarks on result:
- other: No data on maximum score in the report.
- Irritant / corrosive response data:
- All animals showed no reactions of the conjunctivae or cornea. In the other parts of the eye no pathological findings could be discovered.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Following the experimental design according to Hazardous Substances, Part 191, Section 10 and 11; FDA, Washington 1965, the test substance was applied to the back of six New Zealand White rabbits (BASF, 1970). The skin sites were semiocclusively covered. The skin of half of the animals was abraded. The test animals were exposed to the test substance at concentrations of 2500 and 10000 mg/kg bw. Dressings were removed after 24 hours. The animals were observed for 14 days. Irritation was scored by the method of Draize. No skin irritation regarding erythema and edema were observed either on the intact or on the abraded skin.
In a human repeated insult patch test a pre test included the degree of irritation caused by the test substance (please refer to IUCLID section 7.10.4). 50 volunteers (22 males and 28 females) were occlusively exposed to the test substance and did not show any signs of erythema or edema of the treated skin site.
Eye irritation
Following the experimental design according to Hazardous Substances, Part 191, section 12, FDA, Washington 1965, 100 mg of the test substance were instilled into the left eye of 6 New Zealand White rabbits (3/sex) (BASF, 1970). The eyes were not washed. Animals were observed for 72 hours. All animals did not show any reactions of the conjunctivae or cornea. In the other parts of the eye no pathological findings could be discovered.
Justification for selection of skin irritation / corrosion endpoint:
Scientifically acceptable study report.
Justification for selection of eye irritation endpoint:
Scientifically acceptable study report.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled as eye or skin irritating under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled as eye or skin irritating under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC No 605/2014.
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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