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EC number: 412-640-1 | CAS number: 84632-50-8
- 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
Two studies in rabbits were performed to evaluate irritating or corrosive properties of the test material to skin or eyes. Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight, transient opacity and conjuctival irritation. All reaction on skin and eyes has resolved within 8 days or were below treshold of regualtion. Therefore, the substance is considered to be as not-irritating.
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:
- 1992-06-24 to 1993-04-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study. Minor deficiency: 1st reading was done after 30 min instead of 60 min. This has no influence on the reliability of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Sep. 19, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- orange powder
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: yes, duration not specified
ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19°C
- Humidity: 30 - 70%
- Air changes: approximately 19 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period
IN-LIFE DATES: From: 1993-02-09 To: 1993-02-12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: electric clippers
- Vehicle:
- water
- Remarks:
- distilled
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g per animal
- Concentration: 50% w/v
VEHICLE
- Amount applied: 0.5 mL distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- approximately 0.5, 24, 48 and 72 hours after exposure
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 100 mm x 100 mm (% not specified, but approximately 10% of the total body surface)
- Type of wrap if used: gauze pad covered with "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: the treated area of skin was washed with warm (30° to 40°C) water and blotted dry with absorbent paper
- Time after start of exposure: at the end of the 4 hours exposure period
SCORING SYSTEM:
Erythema/eschar and oedema formation: (scoring 0 - 4), according to OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No dermal response to treatment was observed in any animal throughout the observation period.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- 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
- Study period:
- 1992-06-24 to 1993-05-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted Sept. 19, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Analytical purity: 99%
- Appearance: orange powder - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 14 to 15 weeks
- Weight at study initiation: 3.2 to 3.5 kg
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: yes, duration not specified
ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19°C
- Humidity: 30-70%
- Air changes: approximately 19 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period
IN-LIFE DATES: From: 1993-02-15 To: 1993-03-01 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 mg, occupying a volume of 0.1 mL - Duration of treatment / exposure:
- continuous
- Observation period (in vivo):
- approximately 1, 24, 48 and 72 hours after instillation as well as 4 and 7 days after instillation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: according to OECD 405 / EU Guidelines
TOOL USED TO ASSESS SCORE: not specified ("handheld light") - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals #2, #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals #2, #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals #2, #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- A single instillation of the test item into the eye of the rabbit elicited corneal opacification and temporary slight to well-defined conjunctival irritation. All reactions had resolved one or seven days after instillation.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- 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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Procedure and observation
Two studies were performed to evaluate irritating potential of the test material to skin or eyes. In the first study, three male rabbits were each administered a single dermal dose of 0.5 g given as 50% suspension of the test substance. Semiocclusive application of the test material to intact rabbit skin for four hours did not cause any reaction on animals skin.
In a second study, six rabbits were each administered a single ocular dose of 50 mg of the test substance and observed for seven days after instillation. A single instillation of the test material into the eye of the rabbit elicited corneal opacification and temporary slight to well-defined conjunctival irritation. All reactions had resolved one or seven days after instillation.
Discussion
Application of the test substance onto skin did not cause corrosion or irritation. Appllication into the conjunctival sac of the eye caused slight to moderate conjuctival irritation. Conjunctival irritation was not reversible within 8 day post observation period but showed tendency to normalize and the score of irritation was below the treshold of regulation.
Justification for classification or non-classification
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 irritation under Regulation (EC) No. 1272/2008.
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