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EC number: 235-406-9 | CAS number: 12220-06-3
- 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
Not skin/eye 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:
- From November 28th to December 01st, 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- The complete study report is not available, thus some details about test conditions are missing.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg of the test material was administered to the intact skin.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Three males
- Details on study design:
- SCORING SYSTEM
Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
From Draize J H (1959) "Dermal toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Dug Officials of tne US, Austin, Texas p47 - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Primary Irritation Index: 0.2, mild irritant
Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not classified, according to the CLP Regulation (EC) No 1272/2008
- Executive summary:
A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines 404 and Method B4 of Commission Directive 92/69/EEC. A single 4 -hour semi-occluded application (500 mg of the test material) was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.
Primary Irritation Index: 0.2, mild irritant
Conclusion
Mean values from grading at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Skin reaction | Observation time | Individual scores | Total | ||
Male | Male | Male | |||
Erythema/Eschar | 1 | 1 | 2 | 1 | (4) |
24 | 0 | 1 | 0 | 1 | |
48 | 0 | 0 | 0 | (0) | |
72 | 0 | 0 | 0 | 0 | |
Mean 24, 48, 72 hrs |
0.00 | 0.33 | 0.00 | - | |
Oeadema | 1 | 0 | 1 | 0 | (1) |
24 | 0 | 0 | 0 | 1 | |
48 | 0 | 0 | 0 | (0) | |
72 | 0 | 0 | 0 | 0 | |
Mean 24, 48, 72 hrs |
0.00 | 0.00 | 0.00 | - |
() Total values not used for calculation of primary initation index
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:
- December from 04th to 13rd, 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- The complete study report is not available, thus some details about test conditions are missing.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Amount / concentration applied:
- 0.1 ml (93 mg) of the test material as administered to the non irrigated eye.
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- SCORING SYSTEM
Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Irritant / corrosive response data:
- Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)
Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not classified, according to the CLP Regulation (EC) 1272/2008
- Executive summary:
A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5 of Commission Directive 92/69/EEC. A single application 0.1 ml (93 mg)of the test material was administered to the non irrigated eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.
Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.
Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)
Conclusion
The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.
Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Individual and Mean Scores for Cornear lris and Conjunctivae for EU Labelling Regulations
68 male | Mean 24/48/72 hrs | 85 male | Mean 24/48/72 hrs | 86 male | Mean 24/48/72 hrs | |||||||
Time After Treatment | 24 hrs | 48 hrs | 72 hrs | 24 hrs | 48 hrs | 72 hrs | 24 hrs | 48 hrs | 72 hrs | |||
Degree of Comeal Opacity | 0 | 0 | 0 | 0.00 | 2 | 2 | 1 | 1.67 | 0 | 0 | 0 | 0.00 |
Iridial Inflammation | 0 | 0 | 0 | 0.00 | 1 | 1 | 0 | 0.67 | 0 | 0 | 0 | 0.00 |
Conjunctival Redness | 1 | 0 | 0 | 0.33 | 2 | 2 | 1 | 1.67 | 1 | 1 | 0 | 0.67 |
Conjunctival Chemosis | 0 | 0 | 0 | 0.00 | 2 | 2 | 0 | 1.33 | 0 | 0 | 0 | 0.00 |
Individual Scores for Ocular Irritation
68 male | 85 male | 86 male | |||||||||||
Time After Treatment | 1hr | 24 hrs | 48 hrs | 72 hrs | 1hr | 24 hrs | 48 hrs | 72 hrs | 7 days | 1hr | 24 hrs | 48 hrs | 72 hrs |
Degree of Comeal Opacity (E) | 0 | 0 | 0 | 0 | 0S | 2S | 2 | 1 | 0 | 0S | 0 | 0 | 0 |
Area of Corneal Opacity (F) | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
Score (ExF)x5 | 0 | 0 | 0 | 0 | 0 | 20 | 20 | 5 | 0 | 0 | 0 | 0 | 0 |
Iridial Inflammation (D) | 0 | 0 | 0 | 0 | 0S | 1S | 1 | 0 | 0 | 0S | 0 | 0 | 0 |
Score (Dx5) | 0 | 0 | 0 | 0 | 5 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
Conjunctival Redness (A) | 1S | 1 | 0 | 0 | 1S | 2S | 2 | 1 | 0 | 1S | 1 | 1 | 0 |
Conjunctival Chemosis (B) | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
Conjunctival Discharge (C) | 1Sf | 0Sf | 0Sf | 0Sf | 2Sf | 3Sf | 2Sf | 1Sf | 0 | 1Sf | 0Sf | 0Sf | 0Sf |
Score (A+B+C)x2 | 4 | 2 | 0 | 0 | 8 | 14 | 12 | 6 | 0 | 4 | 2 | 2 | 0 |
Total Score | 4 | 2 | 0 | 0 | 8 | 39 | 37 | 11 | 0 | 4 | 2 | 2 | 0 |
S = orange caloured staining
Sf = orange staining of the fur around the eye
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
The key study was performed in New Zealand White rabbit, following the testing procedures outlined into the OECD Guidelines 404 and Method B4. Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.
The results obtained are confirmed by the outcomes of the other three supporting studies available.
EYE IRRITATION
The key study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5. A single application 0.1 ml (93 mg) of the test material was administered; ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration. Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.
The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.
The study outcomes and conclusion were confirmed by three additional supporting available studies.
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
In the key study, the mean values from grading at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.
According to the CLP Regulation (EC) No 1272/2008, serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance, which is not fully reversible within 21 days of application.
The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.
In conclusion, the substance does not meet the criteria to be classified for the eye/skin irritation, according to the CLP Regulation (EC) No 1272/2008.
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