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EC number: 214-160-6 | CAS number: 1103-38-4
- 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
Several studies in rabbits were performed to evaluate irritating or corrosive properties to skin or eyes (OECD guideline 404, 405 and AFDO regulation). Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight conjuctival irritation. All reactions resolved within 2 days or were below the treshold of regualtion. Therefore, the substance is considered to be not-irritating.
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
- 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:
- information to test substance (purity) not given
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight (kg) at study initiation: 2.22 male and 2.28 female
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10h light period - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and right hand site abraded
- Vehicle:
- other: 50% aqueous solution of polyethylene glycol
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g or 1.5 ml
VEHICLE 50% PEG
- Amount(s) applied (volume or weight with unit): 1.5 ml applied on a 2.5 cm2 gauze pad
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 24h
- Observation period:
- after 24 and 72h
- Number of animals:
- 3 per sex
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.83
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and intact skin
- Irritant / corrosive response data:
- A very slight to slight oedema was seen in 5/6 intact and abraded sites 24 hours after application of the compound. All sites were normal by 72 hours. The primary irritation score was 0.5.
- Interpretation of results:
- GHS criteria not met
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
- 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 data to test item given (purity)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight (kg) at study initiation: 2.22 male, 2.28 female
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10h light - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 100 mg of the test compound were instilled into the conjunctiual sac of the left eye. The eyelids uere then held closed for 1 second. The right eye serued as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
- Observation period (in vivo):
- 1, 6, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- see above
SCORING SYSTEM: The ocular reactions uere scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A. - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 6
- Max. score:
- 110
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 110
- Remarks on result:
- other: washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 6h
- Score:
- 6.6
- Max. score:
- 110
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 6h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 110
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: unwashed
- Irritant / corrosive response data:
- A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, washed eyes returning to normal slightly more quickly. All were normal by day 3.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, unwashed eyes returning to normal slightly more quickly. All uere normal by day 3.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Procedure and observations
The test item, 0.5 g dissolved in 50 % PEG, was applied onto shaved or abraded, dorsal rabbits skin (3/sex) and animals were exposed to the substance under occlusive conditions for 24 h (Ciba 1975). Effects on application site were scored 24h and 72h after treatment. Very slight to slight oedema were seen in 5/6 intact and abraded sites 24 hours after application of the compound. All sites were normal by 72h post observation period.
To evaluate the eye irritation potential of the test material, 100 mg of unchanged test material was installed into the conjuctival sac of six rabbits (3/sex). After 30 seconds the eyes of 3/6 rabbits were rinsed with luke warm water. Effects were scored 1, 6, 24, 48 and 72h after treatment. A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, washed eyes returning to normal slightly more quickly. All were normal by day 3.
Discussion
Application of the test substance or the analogue onto skin caused very slight to slight edema which were reversible wihtin post observation period. Application into the conjunctival sac of the eye caused slight conjuctival irritation which was latest reversible within 3 days and which was below the treshold of regulation.
Justification for classification or non-classification
Classification, Labelling, 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 irritation under Regulation (EC) No. 1272/2008,as amended for the second time in Directive (EC 286/2011).
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