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EC number: 406-940-1 | CAS number: 126019-82-7 DP 211
- 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 irritation of the rabbit skin. Very slight to well-defined erythema were observed. Erythema were fully reversible in all animals within 7 days following termination of exposure. Very slight edema which were reversible within 72 hours after the exposure were observed. The test substance also caused mild conjunctival and iridial reactions. The effects on the conjunctivae were fully reversible in all animals within 7 days following instillation.
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:
- January 17, 1989 - January 24, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- (occlusive treatment)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 wks
- Weight at study initiation: 2230 - 2530 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet (Nafag No. 814), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d
- OTHER: All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other flank of the same animal (treated with water)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL of undiluted test article - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 12-16 cm² (flanks)
- % coverage: at least 10
- Type of wrap if used: aluminium foil held in place with adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)
REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 4 h
SCORING SYSTEM: according to the OECD draize system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Other effects:
- At the reading 72 hours the application site of 2 animals appeared somewhat dry and slight scaling was observed. A slight loss of weight was observed in 1 animal on day 3 (considered not to be treatment-related).
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In an acute dermal irritation/corrosion study following OECD guideline 404 and in compliance with GLP, three rabbits were exposed to 0.5 mL of the test substance for four hours. The test substance was applied onto the shaved flanks of the animals using an occlusive dressing. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Erythema and edema reactions were caused by the treatment, reversible within 7 days the latest. Because the mean values of the recordings 24 to 72 hours after application are below the threshold of significance, the test article can be classified as non-irritant.
Reference
Bodyweights (g):
animal #1: (day 1) 2430; (day 3) 2430; (day 7) 2640
animal #2: (day 1) 2530; (day 3) 2530; (day 7) 2680
animal #3: (day 1) 2230; (day 3) 2200; (day 7) 2280
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:
- January 24, 1989 - January 27, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 wks
- Weight at study initiation: 2560-2700 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet (Nafag No. 814), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d
- OTHER: All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye of the animal served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The test item was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The eyes were not washed after instillation.
- Observation period (in vivo):
- 3 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according to the OECD draize system
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the exerimental conditions employed the test item induced mild irritation of the conjunctiva when instilled into the conjunctival sac of albino rabbits. Because the mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, the test item is regarded as non-irritant.
- Executive summary:
In an acute eye irritation/corrosion study according to OECD guideline 405 and in compliance with GLP, single samples of 0.1 mL of the undiluted test article was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation. Instillation of the test substance resulted in mild redness of the conjunctivae, reversible within 2 days the latest. Based on these results and according to the GHS (EU) criteria for classification the test substance does not need to be classified.
Reference
Bodyweights (g):
animal #1: (day 1) 2660; (day 3) 2610
animal #2: (day 1) 2560; (day 3) 2550
animal #3: (day 1) 2700; (day 3) 2730
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation / Corrosion
In the key study performed according to the protocols of OECD 404 (Irritation / Corrosion Study (dermal)), groups of 3 approx. 12 - 14 weeks old albino rabbits were dermally exposed to 0.5 ml of the undiluted test article (96.2% pure) applied for 4 hours to the flank (12 -16 cm²; at least 10% of the body surface) under occlusive conditions. Animals were observed for 7 days. Irritation was scored by the method of OECD draize system. Skin reactions were observed within 3 days, but were fully reversible within 7 days. Erythema (means 24 -72h): 1.66, 1.66 and 0.33 (animal 1, 2 and 3, respectively); Edema (means 24 -72h): 0.66, 0.66 and 0.0 (animal 1, 2 and 3, respectively).
The supporting study performed according to the protocols of OECD 404 (Irritation / Corrosion Study (dermal)), groups of 3 approx. 12 - 14 weeks old albino rabbits were dermally exposed to 0.5 ml of the undiluted test article (96.2% pure) applied for 4 hours to the flank (12 -16 cm²; at least 10% of the body surface) under occlusive conditions. Animals were observed for 7 days. Irritation was scored by the method of OECD draize system. Skin reactions were observed within 3 days, but were fully reversible within 7 days. Erythema: 1.0, 0.33 and 1.33 (animal 1, 2 and 3, respectively); Edema: 0.33, 1.0 and 0.66 (animal 1, 2 and 3, respectively).
Eye Irritation
In the key eye irritation study (OECD 405), 0.1 ml of the undiluted test article (96.2% pure) was instilled into the conjunctival sac of one eye of young adult New Zeeland White rabbits (3 female) for 24 hours. Eyes were not washed after instillation. Animals then were observed for 3 days. Irritation was scored by the method of OECD draize system. Conjunctivae (redness): 0.33, 0.33 and 0.0 (animal 1, 2 and 3, respectively); Chemosis, Cornea and Iris scores were 0.0 at all time points in all animals.
In the supporting eye irritation study (OECD 405), 0.1 ml of the undiluted test article (96.2% pure) was instilled into the conjunctival sac of one eye of young adult New Zeeland White rabbits (3 female) for 24 hours. Eyes were not washed after instillation. Animals then were observed for 3 days. Irritation was scored by the method of OECD draize system. Conjunctivae (redness): 1.66, 1.33 and 1.33 (animal 1, 2 and 3, respectively); Chemosis: 0.66, 0.33 and 1.0 (animal 1, 2 and 3, respectively); Cornea were 0.0 at all time points in all animals; Iris score: 0.0, 0.0 and 0.33 (animal 1, 2 and 3, respectively).
Based on the results above, the test item is considered to be not irritating to both skin and eyes.
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 skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.
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