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EC number: 211-750-5 | CAS number: 693-36-7
- 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 test article caused temporary mild transient reactions in rabbit eyes and on rabbit skin. The procedure for skin testing involved 24h exposure and is more stringent than OECD testing guideline 404. Experimental data on respiratory irritation is not available.
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:
- 1975-12
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No information on housing and light period of 10 h/d. No controls. Patch size too small. Procedure more stringent than OECD testing guideline (24h occlusive application). Considered acceptable since only mild and reversible findings observed.
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous-Substances Regulations under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred on the premises and maintained under a semi-barrier system
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: 2.41 kg (males); 2.24 kg (females)
- Diet: Ad libitum, commercial irradiated diet (Styles-Oxoid)
- Water: Ad libitum
- Acclimation period: 1 w
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 14 / 10 - Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved and abraded
- Vehicle:
- other: polyethylene glycol
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL
- Concentration (if solution): 50 % (w/v)
VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL
- Concentration (if solution): 50 % - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Back
- % coverage: 10 %
- Type of wrap if used: Aluminium foil secured with "Sleek" adhesive tape and enclosed by a 6' wide "Coban" self adhesive bandage fixed to the skin by strips of "Sleek"
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize (scores of 0 - 4 for erythema/eschar and edema) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- Slight to well defined erythema and very slight to moderate oedema were seen on 3/6 rabbits, 24 hours after the application of the compound. All sites were normal by 72 hours.
The primary irritation score was 0.75. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item caused mild skin irritation within 24h that completely healed within 72h if applied occlusively for 24h.
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:
- 1975-10
- 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:
- No indication of the method used to examine ocular reactions. For three of the six rabbits, eyes rinsed after 30 seconds after the test substance application. Without recording of body weight and clinical signs.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred on the premises and maintained under a semi-barrier system
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.41 kg (males); 2.24 kg (females)
- Housing: Individually
- Diet: Ad libitum, commercial irradiated diet (Styles-Oxoid)
- Water: Ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 14 / 10 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- 3 rabbits: eye lid held close for one second, no further washing
3 rabbits: eye lid held close for one second, then flushing with warm water for one minute - Observation period (in vivo):
- 72 h (examination after 1h, 6h, 48h and 72h)
- Number of animals or in vitro replicates:
- 3 rinsed eyes
3 non-rinsed eyes - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Warm water for 1 m (3 animals out of 6)
- Time after start of exposure: 30 s
SCORING SYSTEM: Draize Score (cornea scores 0 - 4, iris scores 0 - 2, conjunctiva scores 0-4 for chemosis and 0 - 3 for redness and discharge) - Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6h
- Remarks on result:
- other: no chemosis at later observation time points. Results based on animals with non-rinsed eyes.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 6h and 24h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: No redness observed at later observation time points. Results based on animals with non-rinsed eyes.
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 h
- Remarks on result:
- other: No further discharge observed at later observation time points. Results based on animals with non-rinsed eyes.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results based on animals with non-rinsed eyes.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Results based on animals with non-rinsed eyes.
- Irritant / corrosive response data:
- No indication of eye corrosion observed.
- Other effects:
- Results are not different if the rinsed eyes are evaluated.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is a minimal eye irritant in the albino rabbit.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The two studies for skin and eye irritation were performed prior to the introduction of OECD testing guidelines and GLP. As such, they have some limitations in reporting details referring to the test item and the housing conditions. Nevertheless, the available information is considered sufficient to assess the irritation hazard. The study for skin irritation was performed according to the method given in the "Hazardous-Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). This method is more stringent than the one outline in OECD testing guideline 404. In cases like this where findings were healed within the observation period, it is suitable for hazard assessment based on EU regulations.
The study for eye irritation follows a design comparable to that of OECD testing guideline 405 and is adequately reported. The substance was applied at 100 mg into one eye of six animals. For three of them eyes were rinsed with water 30 seconds after application. A very slight to slight conjunctival reaction was seen in five of six treated eyes one hour after application of the compound. It resolved within 24h so that overall, the substance is considered to be non irritating.
The study for skin irritation was performed with a design that is more stringent compared to OECD testing guideline 404. Reporting details are adequate for assessment, noting that some details such as body weight and housing conditions were not reported. The substance was applied onto shaved intact or abraded rabbit skin at 0.5 g under an occlusive wrapping for 24h. It was applied using 50% polyethylene glycol as vehicle. For intact skin, one rabbit showed both a slight to well defined erythema and edema with a Draize score of 2 and two other rabbits showed very slight oedema with a Draize score of 1 one day after the application of the compound. The mean Draize scores for 24h were 0.33 for erythema and 0.67 for edema. As all sites were normal by 72 hours the study is considered suitable for classification and labelling. Application onto abraded skin resulted in slightly higher mean scores (0.83 for erythema and 1.17 for edema).
Experimental data on respiratory irritation is not available.
Justification for classification or non-classification
Classification, Labeling, 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.
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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