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EC number: 223-829-1 | CAS number: 4090-51-1
- 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
No signs of skin irritation were observed in two Draize tests in rabbits (one reliable RL2, the other less reliable, RL3), supported by the absence of irritating effects in a reliable LLNA with mice.
The test substance was not irritating to the eyes in two reliable studies (RL1).
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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Standard protocol with some deficiencies in data reporting
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Skin irritation test according to Draize
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- no details
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0,5 g
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- Exposure period 24 h in this study, compared to 4 h in OECD guideline 404
Use of impervious wrap
SCORING SYSTEM:
Evaluation of results according to ETAD score system: Values for erythema and edema (maximal score: 4 each) for intact and abraded skin at 24 and 72 h are added and divided by 4 to give the primary irritation score:
0 - 0.5: non irritant
0.6 - 3.0: slightly irritant
3.1 - 5.0: moderately irritant
5.1 - 8.0: severely irritant - Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals were treated on abraded skin
- Time point:
- other: 24h and 72h
- Score:
- 0.166
- Max. score:
- 1
- Reversibility:
- other: Edema were observed in 6 animals on abraded skin at 72 h time point. No longer observation period described.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals were treated on abraded skin
- Time point:
- other: 24h and 74h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No erythema observed on abraded skin at any time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals were treated on intact skin
- Time point:
- other: 24h and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed in intact skin at any time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals were treated: intact skin
- Time point:
- other: 14 h and 72 h after treatment
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No erythema observed on intact skin at any time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed on intact skin
- Remarks on result:
- other: Based on the evaluation scheme of guideline OECD 404, the effects on intact skin indicate an irritation score of 0 (based on restricted observation period at 24 and 72 h only)
- Irritation parameter:
- overall irritation score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- other: Edema of grade 1 observed in all animals after 72 h on abraded skin. Reversibility not described as the observation period ended at 72 hours.
- Remarks on result:
- other: ETAD score
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test substance was not irritating to skin
- Executive summary:
The test substance was applied to the skin of 6 albino rabbits for 24 h under an occlusive wrap. Skin reaction were evaluated at the end of exposure (time point 24 h) and 48 h thereafter (time point 72 h) according to the ETAD classification system. No skin irritation was observed in this study.
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:
- 1989-04-21 to 1989-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.4-2.7 kg
- Housing: individually in stainless steel cages
- Diet (ad libitum): Kliba 341, Batch 44/89 rabbit maintenance diet, Klingentalmühle, Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as internal control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- up to 72 h
- Observation period (in vivo):
- up to 72 h
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- SCORING SYSTEM:
according to OECD 405 and EU B.5
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Remarks:
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed at any time point
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed at any time point in any eye
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed at any time point
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the test substance was not irritating to the eyes of rabbits.
- Executive summary:
The test substance was subject to an eye irritation test according to guidelines OECD 405 and EU B.5. 0,1 mL of the test item were instilled into the eyes of 3 rabbits and irritating effects were evaluated up to 72 h after application. The untreated eyes served as internal controls. No effects were observed. Under the conditions of the study the test substance was not irritating to the eyes of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Two Draize tests with respect to irritation to rabbit skin are available. The submission substance was applied in two different forms: “active substance” was tested in a reliable study (RL2), “dispersion” in a less reliable study (RL3). No signs of irritation were observed on intact skin in both of the studies. The results could be evaluated according to OECD guideline, resulting in a score of 0 at any time point.
Supporting information can be drawn from a reliable (RL1) LLNA with mice (chapter 7.4.1), where no signs of skin irritation were evident.
Eye irritation
Two eye irritation studies are available, both according to guideline (RL1). The submission substance was applied in two different forms. In both studies there were no signs of irritation at any time point.
Justification for selection of skin irritation / corrosion endpoint:
Study equivalent to current guideline.
Justification for selection of eye irritation endpoint:
Two studies of identical quality with two different test items of the same submission substance are available
Justification for classification or non-classification
No evidence for skin irritation is emerging from a reliable Draize test, and the findings are supported by a less reliable study and a reliable LLNA. Therefore, the test substance has not to be classified for skin irritation according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.
Based on the absence of eye irritation in reliable studies, the test substance has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.
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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