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EC number: 209-909-9 | CAS number: 597-82-0
- 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
The substance caused transient, slight irritation of the rabbit skin evidenced as very slight to well-defined erythema and very slight edema. Erythema was fully reversible in all animals within 72 hours following the commencement of exposure. Edema (very slight) seen in only 2 animals was fully reversible within 72 hours after the start of exposure. The test substance caused no irritating effects on the 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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (48 hour scoring not performed, 10/14 hour dark/light rhythm, treatment on intact and abraded skin, occlusive treatment, 24 hour long treatment)
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit food (NAFAG Gossau SG)
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated parts of the same rabbit
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Scoring of skin irritation was performed 24 and 72 hours after initiation of treatment. Animals were observed until the reversal of irritation effects.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Two days before treatment the entire back, and the flank of the rabbits were shaved and immediately before treatment, the shaven skin of the left side was slightly scarified. The right side was not scarified.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patches were covered with an impermeable material and fastened with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 hours
SCORING SYSTEM: draize system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after start of treatment
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after start of treatment
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after start of treatment
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after start of treatment
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after start of treatment
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after start of treatment
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- edema score
- Basis:
- animal: 2, 3, 4 and 6
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 48h not investigated
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24 and 72 hours after start of treatment
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours after start of treatment
- Remarks on result:
- other: 48h not investigated
- Other effects:
- Effects on scarified skin 24 hours after start of exposure (6 animals)
- Erythema: 2 (each of 5 animals), 1 (1 animal)
- Edema: 1 (each of 4 animals), 0 (2 animals)
Effects on scarified skin 72 hours after start of exposure (6 animal)
- Erythema: 1 (each of 4 animals), 0 (2 animals)
- Edema: 0 (all animals) - Interpretation of results:
- GHS criteria not met
Reference
Only results of the non scarified skin sections are adopted in the final assessment for skin irritation.
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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (10/14 hour dark/light rhythm, 6 test animals)
- Principles of method if other than guideline:
- Draize method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit food (NAFAG Gossau SG)
- Water: ad libitum
- Acclimation period: 8 days. Only rabbits with normal opthalmic findings were used in the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye (not treated)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- After instillation, eyes were not washed.
- Observation period (in vivo):
- Eye irritation was scored on day 1, 2, 3, 4, and 7.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes (in 3 of 6 animals); with luke warm water
- Time after start of exposure: 30 sec after instillation
SCORING SYSTEM: draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Score for each animal and each measure parameters on day 4 and 7 after treatment = 0
- Interpretation of results:
- GHS criteria not met
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 a primary dermal irritation study, performed using a method identical to that described in the Federal Register, 38, No.187 §1500.41, 0.5 g of the test substance (no data on analytical purity) was applied under occlusive cover to the intact and abraded skin (2.5 x 2.5 cm) of 6 rabbits of russian breed. Treatment was terminated (skins were not washed) 24 hours following application and the animals were observed until reversal of skin irritation symptoms. Irritation was scored according to the Draize method 24 and 72 hours after begin of treatment. Average scores per animal - computed from the individual scores on intact skin at the 24 and 72 hour post start of treatment - ranged from 0 - 1 for erythema (maximal attainable score = 4), and 0 – 0.5 for edema (maximal attainable score = 4). All effects were reversible within 72 hours after start of exposure. Because of its lack of scientific justification and gross deviation from today's acceptable standardized procedures for the appraisal of skin irritation, results from the abraded skins are not included in the final judgment for skin irritation of the test substance (1976).
Eye irritation
The eye irritation potential of the test substance was determined in a procedure identical to the procedure described in the Federal Register 38, No.187 §1500.42. 0.1 g of the substance was applied to the conjunctival sac of the left eye of 6 rabbits each after which the eye lids were closed for one second. The right eye remained untreated and served as control. 30 sec. after instillation the treated eyes were rinsed with water in 3 of the 6 animals. Irritation was appraised after 24, 48, 72, 96 and 168 hours. Average draize scores after 24, 48 and 72 hours were calculated per animal for corneal opacity, iritis, conjunctivae redness and chemosis and used for assessment of irritation potential. No indication of eye irritation was seen: All scores for redness, corneal opacity, chemosis and iritis were zero in all animals (1976).
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 the purpose of classification. Based on the criteria laid down in Regulation (EC) No.1272/2008, classification for skin or eye irritation 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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