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EC number: 288-107-0 | CAS number: 85650-96-0
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: males: ca. 2.33 kg; females: ca. 2.59 kg
- Housing: 1 animal per cage in stainless steel wire mesh cages
- Acclimation period: at least 8 days before the beginning of the study
- Diet: Kliba Labordiaet 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), ca. 130 g per animal per day
- Water: ca. 250 ml per animal per day
- Clipping of the fur: at least 15 h before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Photoperiod: 12 hrs dark / 12 hrs light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin sites of the same animal served as control
- Amount / concentration applied:
- ca. 0.5 g of a 50 % aqueous suspension of the test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males and 1 female
- Details on study design:
- A test patch (2.5 cm x 2.5 cm) is covered with an ca. 0.5 mm layer of the 50 % suspension and applied on the upper third of the back or flanks of the animals.
At the end of the exposure period, the treated sites are washed with lutrol and lutrol/water (1:1).
The readings are made 30-60 min after removal of the patch and 24, 48 and 72 h after beginning of the application.
If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No irritation of the skin was observed in all animals at any time point.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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: well-documented, scientifically acceptable study report. Little information on test item. Only 8 days observation period.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 8-day observation period.
- Principles of method if other than guideline:
- according to Federal Register 38 , No. 187, § 1500.42, p. 27029 of Sep. 27, 1973 (Draize test)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Mean body weight: male 2.32 kg, females 2.47 kg
The animals were offered a standardized animal laboratory diet. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 77 mg (corresponding to 0.1 ml bulk volume)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Scoring according to Draize.
The test substance was not washed out. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- other: reversible in 2/3 animals within 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Redness (score 1) on day 8
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Interpretation of results:
- Category 2A (irritating to eyes)
Reference
Table 1: Individual results
cornea | cornea | conjunctivae | conjunctivae | conjunctivae | ||||
Time point | Animal no. | opacity | area | iris | redness | chemosis | discharge | remarks |
24h | 1 | 2 | 4 | 1 | 2 | 2 | 3 | E/NA/PV |
24h | 2 | 1 | 4 | 1 | 2 | 2 | 2 | NA |
24h | 3 | 1 | 4 | 1 | 2 | 2 | 2 | NA |
48h | 1 | 2 | 4 | 1 | 2 | 2 | 3 | E/NA/PV |
48h | 2 | 1 | 4 | 0 | 2 | 2 | 1 | NA |
48h | 3 | 1 | 3 | 1 | 2 | 2 | 1 | NA |
72h | 1 | 2 | 2 | 1 | 2 | 2 | 3 | E/NA/PV/J |
72h | 2 | 1 | 2 | 0 | 2 | 2 | 1 | NA/J |
72h | 3 | 1 | 2 | 1 | 2 | 2 | 1 | NA/J |
8 days | l | 0 | 0 | 0 | 1 | 0 | 1 | NA |
8 days | 2 | 0 | 0 | 0 | l | 0 | 0 | NA/J |
8 days | 3 | 1 | 1 | 0 | 1 | 0 | 0 | NA/J |
J = Iris partially coloured
NA = Scar
PV = pupil narrowed
E = pus/sanies
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The substance was tested in rabbits according to a BASF protocol in 1980. The protocol is more stringent than OECD testing guideline 404 but uses a shorter observation period. It shows that the substance is not irritating to rabbit skin. Modern experimental data for structurally related substances confirming absence of a skin irritating potential is used as supporting evidence. Details are shown in the read-across justification attached to the endpoint summary of skin sensitization and genotoxicity.
Eye irritation
The substance was tested in rabbits according to a BASF protocol in 1980. It shows that the substance causes irritating effects on eyes. Effects show a trend toward reversibility, but the effects were not fully reversible within the observation period of 8 days. Mean scores for the values of the first three days are below the threshold for classification and labelling as "highly irritating". Modern experimental data for a structurally related substance confirms that the substance needs to be classified as an eye irritant.
The data matrix and accompanying information is attached to the Endpoint summaries of skin irritation and genotoxicity.
Effects on eye irritation: irritating
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 is not considered to be classified for skin irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
The criteria for classification as an eye irritant (Xi, R36) are fulfilled.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013. The criteria for classification as irritating to eyes (H319) are fulfilled.
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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