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EC number: 931-714-9 | CAS number: 35255-57-3
- 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
The test item showed no irritant effects on the skin of female rabbits in a study according to a OECD 404 (Hüls AG, 1996). The test item causes irreversible damage to eyes in a study according to OECD 405 in rabbits (Hüls AG, 1996).
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:
- 1996-03-11 to 1996-03-15
- 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:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: New Zealand white, HsdPoc:NZW
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Sex: female
- Weight at study initiation: 3.3; 3.6; 4.2 kg
- Housing: single
- Diet (e.g. ad libitum): Sniff K 4, complete feed for rabbits, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Total volume applied: 0.5 ml undiluted test item
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 30-60 minutes, 24, 48, and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml test item
- Occlusion: gauze dressing fixed with non-irritant plaster, Acrylastic bandage
- Removal of test substance: washing with warm water
- Post exposure period: 3 days
EXAMINATIONS
- Examination time points: 30-60 minutes, 24, 48, and 72 hours after patch removal
- Scoring system: OECD Guideline - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
REVERSIBILITY: not applicable - Conclusions:
- According to the study, the test item showed no irritant effect on the skin of female rabbits.
- Executive summary:
The aim of this study was to examine the test item for acute skin irritation in rabbits (Patch-test) .
To test the acute skin irritant effect the test item was applied to the shaven dorsal skin of 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.
According to the study, the test item showed no irritant effect on the skin of female rabbits.
Reference
no other results
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:
- 1996-05-21 to 1996-06-19
- 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:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Small white Russian, Mol:Russian / Chbb: HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Mol:Russian / Chbb: HM
- Source: Moellegaard Breeding & Research Cetre Ltd., 4623 Ll.Skensved (Denmark)
- Sex: male
- Weight at study initiation: 3.2 - 3.3 kg
- Housing: single
- Diet (e.g. ad libitum): Sniff K 4, complete feed for rabbits, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- undiluted
test item
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 28 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Vehicle: none
- rinsed after 24 hours
- Postexposure observation period: 28 days
EXAMINATIONS
- Ophtalmoscopic examination: 1 and 24, 48, 72 hours, 6, 8, 10, 13, 17, 21, 24 and 28 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 28 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 28 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 1.33
- Iris: 0.44
- Conjunctivae (Redness): 1.00
- Conjunctivae (Chemosis): 2.00
- Overall irritation score: not reported
REVERSIBILITY: incomplete by day 28 (end of study), i.e. irreversible damage - Other effects:
- OTHER EFFECTS: Typical observations were: exsudation and circumcorneal hyperemia (1-24 hours); bleeding in eyelids and nictitating membrnes (24-72 hours);
slight circumcorneal injection (day 6); recovery - Conclusions:
- The test substance causes irreversible damage to eyes in a study according to OECD 405 in rabbits.
- Executive summary:
This study was performed to examine eye irritating effects of test item according to OECD TG 405 in rabbits. 0.1 ml of undiluted test substance was applied in the conjunctival sac of one eye per animal of three male rabbits with rinsing after 24 hours.
Eye irritation index was assessed using Draize scale. The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 1.33, iris: 0.44, conjunctivae: redness: 1.00 and chemosis: 2.00 (mean scores on Draize scale). Typical observations were: exsudation and circumcorneal hyperemia (1-24 hours); bleeding in eyelids and nictitating membranes (24-72 hours); slight circumcorneal injection (day 6); recovery. The reversibility were incomplete by day 28 (end of study), i.e. irreversible damage.
Reference
AVERAGE SCORE
- Cornea: 1.33
- Iris: 0.44
- Conjunctivae (Redness): 1.00
- Conjunctivae (Chemosis): 2.00
- Overall irritation score: not reported
REVERSIBILITY: incomplete by day 28 (end of study), i.e. irreversible damage
OTHER EFFECTS: Typical observations were: exsudation and circumcorneal hyperemia (1-24 hours); bleeding in eyelids and nictitating membrnes (24-72 hours); slight circumcorneal injection (day 6); recovery
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data the test item is not irritating to skin and therefore must not be classified according to criteria of EC Regulation 1272/2008.
Based on the available data the test substance causes irrversible damage to eyes and hence according to criteria of EC Regulation 1272/2008 the test substance is classified as eye damage Cat. 1; H318 "Causes serious eye damage".
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