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EC number: 212-572-0 | CAS number: 827-52-1
- 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
Skin irritation:
- mean erythema scores (24, 48, 72h): 2 (for 3 animals)
- mean oedema scores (24, 48, 72h): 2 (for 2 animals); 2.7 (for 1 animal)
Eye irritation:
- mean cornea scores (24, 48, 72h): 0 (for 3 animals)
- mean iris scores (24, 48, 72h): 0 (for 3 animals)
- mean conjunctivae scores (24, 48, 72h): 0.3 (for 3 animals)
- mean chemosis scores (24, 48, 72h): 0 (for 3 animals)
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study according to international guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17 July 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum (Certified Rabbit Diet (Code 5322) supplied by PMI Nutritional International, Nottingham, UK)
- Water: ad libitum
- Acclimation period: ≥ 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): ≥ 15 days
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.2
- Reversibility:
- fully reversible within: 14 days
- Conclusions:
- The test material produced a primary irritation index of 4.2.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.
A single 4 -h, semi-occluded application of the test material to the intact skin of 3 rabbits produced well-defined erythema and slight to moderate oedema. Other skin reactions noted were oedema extending ventrally below treatment site, loss of skin elasticity, severe desquamation, reduced regrowth of fur and crust formation, which prevented evaluation of erythema and oedema. No corrosive effects were noted.
The test material produced a primary irritation index of 4.2.
Reference
Erythema/eschar formation
Reading (hrs) | Individual scores - Rabbit number and sex | ||
11 Male | 118 Male | 119 Male | |
24 | 2 | 2 | 2 |
48 | 2 | 2 | 2 |
72 | 2 | 2 | 2 |
Mean score | 2 | 2 | 2 |
Oedema formation
Reading (hrs) | Individual scores - Rabbit number and sex | ||
11 Male | 118 Male | 119 Male | |
24 | 2 | 3 | 2 |
48 | 2 | 3 | 2 |
72 | 2 | 2 | 2 |
2.0 | 2.7 | 2.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study according to international guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum (LABDIET 5322, PMI Nutrition International, Nottingham, UK)
- Water: ad libitum
- Acclimation period: ≥ 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70
- Air changes (per hr): ≥ 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize JH (1977)
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced an overall average score of 3.3 after 1 h.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit.
A single application of the test material to the non-irrigated eye of 3 rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48 h observation. The test material produced an overall average score of 3.3 after 1 h.
Reference
Individual scores and individual total scores for ocular irritation.
Rabbit n° and sex |
61 Male |
155 Male |
156 Female |
|||||||||
Time after treatm. |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
Cornea E = Degree of opacity F = Area of cornea |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Score (E x F) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae A = Redness B = Chemosis C = Discharge |
2 1 2 |
1 0 1 |
0 0 0 |
0 0 0 |
2 1 2 |
1 0 1 |
0 0 0 |
0 0 0 |
2 1 1 |
1 0 0 |
0 0 0 |
0 0 0 |
Score (A + B + C) x 2 |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
8 |
2 |
0 |
0 |
Total Score |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
8 |
2 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One key study is available for skin irritation, and one for eye irritation.
Skin irritation
The key study that is available on skin irritation is a well-documented in vivo study according to OECD 404 (Sanders, 2001 (d)). In this experiment, a single 4 h, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight to moderate oedema. Other skin reactions noted were oedema extending ventrally below treatment site, loss of skin elasticity, severe desquamation, reduced regrowth of fur and crust formation, which prevented evaluation of erythema and oedema. No corrosive effects were noted.
Eye irritation
The key study that is available for eye irritation is a well-documented in vivo study according to OECD 405 (Sanders, 2001 (e)). In this experiment, a single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation 1h after test substance administration. All treated eyes appeared normal at the 48 h observation.
The findings of the available supporting studies for skin and eye irritation are in line with those of the key studies.
Justification for selection of skin irritation / corrosion endpoint:
The study is GLP compliant and has Klimisch score 1.
Justification for selection of eye irritation endpoint:
The study is GLP compliant and has Klimisch score 1.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
The observed skin effects showed a mean (24 - 48 -72h) value of 2.7 in one animal. The mean value for the other two animals is < 2.3, and all effects are fully reversible within 14 days. Therefore, according to the criteria described in section 3.2.2 of EU Regulation n° 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), the skin irritation scores as determined in the in vivo skin irritation tests do not require a classification as skin corrosive or skin irritant.
According to the criteria described in section 3.2.5 - 3.2.6 of Annex VI to Council Directive 67/548/EEC on the Classification, Packaging and Labelling of Dangerous Substances (DSD), classification as Xi, R38; irritating to the skin is required.
According to the criteria described in section 3.3.2 of EU Regulation n° 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), the eye irritation scores as determined in the in vivo eye irritation tests do not require a classification as eye irritant.
According to the criteria described in section 3.2.5 - 3.2.6 of Annex VI to Council Directive 67/548/EEC on the Classification, Packaging and Labelling of Dangerous Substances (DSD), the result of the eye irritation test does not require a classification for eye irritant.
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