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EC number: 252-488-1 | CAS number: 35285-69-9
- 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/corrosion (OECD 404): not irritating
Eye irritation (OECD 405): corrosive
The test material, when evaluated for primary skin irritation by a 4
-hour patch test conducted on intact rabbit skin, was found to be not
irritating.
The test item ether was tested for its eye irritant properties in 3 New
Zealand White rabbits. The study was performed according to OECD
Guideline 405. Effects on cornea and conjunctivae (redness and swelling)
were observed in all animals one hour after application. These signs
were irreservible.
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:
- Aug 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not required, the untreated sites of the same animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g test substance, moistened with water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
reading time points: 1, 24, 48, 72 h and 7 d - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm² on the back of the animal
- Type of wrap if used: The test substance was applied to a gauze patch, held in place by elastic tape that was permeable to air.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin sites were washed with water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Dermal application of the test substance did result in slight erythema in only one of three animals and no edema in any of the animals tested at any observation time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- When evaluated for primary skin irritation by a 4-hour patch test conducted on intact skin the test material was found to be not irritating.
- Executive summary:
The test item was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. Dermal application of the test substance did result in slight erythema (fully reversible within 7 days) in only one of three animals and no edema in any of the animals tested at any observation time point.
With reference the reported effect in one of three animals and its reversibility the test substance does not need to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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:
- Aug - Sept 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not required, the untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL finely powdered test substance (corresponding to max. 0.1 mg test substance) - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 20 d
reading time points: 1, 24, 48, 72 h, 16 d and 20 d - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: At the 24 h reading time point, 1% fluorescein solution was used to stain the cornea. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- 1 h after application all animals showed strong irritant eye effects which were not reversible within the 20 d observation period. Due to the strong cornea effects the iris score could not be determined. One animal was killed for humane reasons on observation day 16.
- Interpretation of results:
- other: Eye Dam. 1 according to Regulation (EC) No 1272/2008
- Conclusions:
- Based on the observed effects and the irreversibility the substance has to be classified as Eye Dam. 1 (H318).
- Executive summary:
The test item ether was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling) as well as on the cornea and were observed in all animals one hour after application. These signs were not reversible within 20 d. Due to the strong cornea effects the iris score could not be determined. One animal was killed for humane reasons on observation day 16.
With reference the reported scores and the irreversibility of the observed effects test substance has to be classified as Eye Dam. 1 (H318) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of the test substance was determined in an in vivo skin irritation test (Bayer, 1983) in New Zealand White rabbits according to OECD Guideline 404. 0.5 g of the test substance moistened with water were applied to the clipped skin of three male rabbits under semi-occlusive conditions. After an exposure period of 4 h the patch was removed and the skin sites were washed with water. Scores were taken 1, 24, 48 and 72 hours and 7 days after patch removal using the Draize scoring system. Dermal application of the test substance did result in slight erythema in only one of three animals (fully reversible within 7 days) and no edema in any of the animals tested at any observation time point. The mean scores for 24/48/72 h reading for erythema were 0, 1 and 0 and for edema 0, 0 and 0 for the 3 animals. Based on the results, the undiluted test substance was not irritating to the skin under the conditions of the test.
The test substance was tested for its eye irritant properties in 3 New Zealand White rabbits (Bayer, 1983) according to OECD Guideline 405. 1 mL of the test material was placed in one eye of each animal. The other eye remained untreated and served as control. The eyes were examined for effects on conjunctivae (redness and swelling) as well as on the cornea and scored according to Draize 1, 24, 48, 72 hours, 16 and 20 days after application. The mean scores for 24/48/72 h reading for corneal opacity were 3, 3.3 and 4 for each of the 3 rabbits, respectively. For conjunctivae redness and chemosis mean scores were 2 and 3 for all animals, respectively. These signs were not reversible within 20 d. Due to the strong cornea effects the iris score could not be determined. One animal was killed for humane reasons on observation day 16. Based on the results of this study, the test substance was corrosive to the eye under the conditions of the test.
Justification for classification or non-classification
With reference the reported scores and the reversibility of the observed effects test substance does not have to be classified as irritant to the skin according to the criteria laid down in theEU Classification Labelling and Packaging Regulation (1272/2008/EC).
Based on the available results thetest substance has to be classified as Eye Dam. 1 (H318) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Justification for selection of
skin irritation / corrosion endpoint:
Well reported guideline conform study.
Justification for selection of eye irritation endpoint:
Well reported guideline conform study
Effects on eye irritation:corrosive
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