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EC number: 269-284-3 | CAS number: 68214-04-0
- 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
Six rabbits were exposed dermally (under occlusion) to 0.5 g of the substance for 24 hours. Very limited oedema and erythema were reported at the 24 h examination. These effects were fully reversible after 72 hours. The substance is not irritating to the skin (Ciba 1974).
A study similar to OECD 405 was performed. The substance was installed in the conjuntival sac of the eye of 6 rabbits. The eyes of 3 of these were washed after 30 seconds. Observations for irritancy were done at 1, 6, 24, 48 and 72 hours after installation. No irritant effects became apparent except for slight cornea effects and slight redness that were fully reversible after 72 hours. There was no difference between animals with washed eyes and animals that were not washed. Therefore it is concluded that the substance is not irritating to the eyes (Ciba 1974)
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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP test which contains sufficient information to allow a conclusion (worst case exposure under occlusion during 24 hours)
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance applied under occlusion to 2.5 cm2 for 24 hours; readings at 24 and 72 hours
- Principles of method if other than guideline:
- 6 animals were treated at both flanks, one of these sides was abraded before application. Only the results for the intact side are reported in this smmary.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred on premisses
- Strain: Porton
- Age at study initiation: 11-12 weeks
- Average weight at study initiation: 4 males 2.39 kg; 2 females 2.48 kg
- Housing: individually
- Diet: Styles-Oxoid (irridiated) ad libitum
- Water: sterilised ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 1 ± 1 °C
- Humidity (%): 50-70 %
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 14/10 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.66 g/mL
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.75 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 4 males and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2 - Type of wrap if used: covered with aluminium foil secured with "Sleek" adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: similar to Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- >= 0 - <= 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean at 24 h 0.33
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- >= 0 - < 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean at 24 h 0.67
- Irritant / corrosive response data:
- non irritant
- Other effects:
- none reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered not irritating to the skin
- Executive summary:
Six rabbits were exposed dermally (under occlusion) to 0.5 g of the substance for 24 hours. Very limited oedema and erythema were reported at the 24 h examination. These effects were fully reversible after 72 hours. The substance is not irritating to the skin.
Reference
Animal |
erythema |
oedema |
||
|
24h |
72h |
24h |
72h |
1 |
1 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
1 |
0 |
6 |
1 |
0 |
2 |
0 |
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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, non-GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: own breeding
- Age at study initiation: 12-13 weeks
- Average weight at study initiation: 4 males 2.39 kg; 2 females 2.48 kg
- Housing: individually
- Diet: ad libitum (Styles-Oxoid)
- Water: sterile filtered water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50-70%
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 14/10 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg (0.1 mL) - Duration of treatment / exposure:
- single treatment, in 3 animals eyes were washed after 1 hour
- Observation period (in vivo):
- 1, 6, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 4 males and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes in 3 animals
- Time after start of exposure: after 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with 30 mL of warm water.
SCORING SYSTEM: similar to Draize (Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the USA )
TOOL USED TO ASSESS SCORE: none mentioned - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.04
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- very slight difference between animals with eyes washed or not
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eyes
- Executive summary:
A study similar to OECD 405 was performed. The substance was installed in the conjuntival sac of the eye of 6 rabbits. The eyes of 3 of these were washed after 30 seconds. Observations for irritancy were done at 1, 6, 24, 48 and 72 hours after installation. No irritant effects became apparent except for slight cornea effects and slight redness that were fully reversible after 72 hours. There was no difference between animals with washed eyes and animals that were not washed. Therefore it is concluded that the substance is not irritating to the eyes
Reference
Animal no | 1 | 2 | 3 | washed | |||||||||||
1 | 6 | 24 | 48 | 72 | 1 | 6 | 24 | 48 | 72 | 1 | 6 | 24 | 48 | 72 | |
cornea | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
conjunctivae | |||||||||||||||
redness | 2 | 2 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 0 |
chemosis | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
discharge | 2 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Animal no | 4 | 5 | washed | 6 | washed | ||||||||||
1 | 6 | 24 | 48 | 72 | 1 | 6 | 24 | 48 | 72 | 1 | 6 | 24 | 48 | 72 | |
cornea | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
conjunctivae | |||||||||||||||
redness | 2 | 2 | 1 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 |
chemosis | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
discharge | 3 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data the substance does not need to be classified for skin and eye irritation according to Regulation ((EC) No 1272/2008 (CLP)
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