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EC number: 270-331-5 | CAS number: 68424-95-3
- 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
There are no studies avalilable for the assessment of skin sensitisation potential of the substance. However, the substance is corrosive and so this endpoint can be waived.
There are two skin sensitisation studies available for a structurally similar substance and these have been provided for completeness.In an amended guinea pig maximisation test to evaluate the sensitisation potential of the substance male and female mice (ten animals/sex) were exposed (occlusive) topically to the substance at 0.2% w/v in water during first application followed by 7 topical (occlusive) applications at 5% w/v in water every 48 hours. Following a resting period of 12 days a challenge application was administered topically for 48 hours employing 0.2% w/v in water at 0.5 mL a site away from the site of initial induction. The skin site was monitored for any signs of irritation at 6, 24 and 48 hours post-application. A skin biopsy was taken from those animals in which irritation was observed at 6 hours following the challenge application. Macroscopic and histological evaluations were conducted on these tissues. No other animals exibited signs of irritation for the remainder of the study.Macroscopic and histological evaluations were conducted on these tissues as well. The findings indiacte that the substance is not a skin sensitiser or is a weak sensitiser as reported by the study facilitator. In the second study a Beuhler assay was employed to evaluate the sensitisation potential the substance (0.25%, 0.5% or 0.75%) was administered topically to guinea pigs (20 animals/concentration) once each week for a 3 week induction period. Twenty seven days after the first induction dose, a challenge dose of the test substance at its highest non-irritating concentration was applied to a naive site on each guinea pig. A naive control group (ten animals) was maintained under the same environmental conditions and treated with the substance at challenge only. The animals were scored for erythma approximately 24 hours and 48 hours after each induction and challenge dose. Based on the results of this study, the substance is not considered to be a contact sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 28th January 1987 - 20th March 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: the protocol of Guillot-Gonnet-Clément-Brulos published by the AFNOR: FD n° T03-300
- Deviations:
- no
- Principles of method if other than guideline:
- Guinea-pig maximisation test.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea-pig maximisation study was conducted prior to LLNA methodology availability.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Various
- Females nulliparous and non-pregnant:[yes
- Weight at study initiation: 300 to 500 g
- Housing: Polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days before the begining of treatment
- Indication of any skin lesions: none.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 to 70% RH
- Photoperiod (hrs dark / hrs light): a 12-hour light-dark cycle - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.2% w/v at 0.5 mL
- Day(s)/duration:
- Initial application
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% w/v in 0.5 mL
- Day(s)/duration:
- Every 48 hours following initial application for a total of 7 applications.
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.2% w/v at 0.5 mL
- Day(s)/duration:
- 48 hours
- No. of animals per dose:
- 10/sex
1/sex untreated. - Details on study design:
- RANGE FINDING TESTS: A minimum of one treated group of 2 males and 2 females were dosed 0.5 mL (this being the maximum quantity applicable under an occlusive patch) of concentrations of 100% and 0.2% w/v in water . Two concentrations per animal were administered to clipped skin on the dorsal area for 48 hours and kept in contact with the skin under an occlusive patch. The substance was applied once and cutaneous examinations were carried out 6, 24 and 48 hours after removal of the patches.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 7 exposures.
- Exposure period: 48 hours.
- Test groups: 1 test group
- Control group: 1 control group
- Site: clipped upper thoracic region, just behind the right scapulum.
- Frequency of applications: every 48 hour
- Concentrations: 0.5 mL
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Site: untreated region of the abdominal lateral region.
- Concentrations: 0.5 mL
- Evaluation (hr after challenge): 6, 24 and 48 hours after removal of the occlusive patch.
- Challenge controls:
- Untreated animal served as controls because the substance was used as supplied (i.e. no vehicle).
- Positive control substance(s):
- no
- Positive control results:
- Not applicable.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 6
- Group:
- test chemical
- Dose level:
- 5% w/v challenge
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- None.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% w/v challenge
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% w/v challenge
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance at 5% w/v not produce any cutaneous sensitising reaction (nil or very weak) in 19 out of 20 animals in the guinea pig maximisation test.
- Executive summary:
In an amended guinea pig maximisation test to evaluate the sensitisation potential of the substance male and female mice (ten animals/sex) were exposed (occlusive) topically to the substance at 0.2% w/v in water during first application followed by 7 topical (occlusive) applications at 5% w/v in water every 48 hours. Following a resting period of 12 days a challenge application was administered topically for 48 hours employing 0.2% w/v in water at 0.5 mL a site away from the site of initial induction. The skin site was monitored for any signs of irritation at 6, 24 and 48 hours post-application. A skin biopsy was taken from those animals in which irritation was observed at 6 hours following the challenge application. Macroscopic and histological evaluations were conducted on these tissues. No other animals exibited signs of irritation for the remainder of the study. Macroscopic and histological evaluations were conducted on these tissues as well. The findings indiacte that the substance is not a skin sensitiser or is a weak sensitiser as reported by the study facilitator.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 21 June 2004 - 30th july 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted for non-EU REACH purposes.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: #D4223025
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at RT
- Stability under test conditions: Expected to be stable for the duration of the test
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in distilled water - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chemlsford, MA.
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: Young adult males 312 - 365 g and females 313 - 380 g.
- Housing: Suspended stainless steel caging with mesh floors or perforated bottom caging.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6, 27 or 31 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-24°C
- Humidity (%): 50-70%
- Photoperiod (hrs dark / hrs light): 12-hour lightt/dark cycle - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.25%, 0.5% or 0.75% - induction phase
0.1% - challenge phase - Day(s)/duration:
- Induction phase was conducted once each week for 3 weeks.
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- Challenge phase was conducted 27 days after the first induction dose. These sites were evaluated for a sensitisation response approximately 24 and 48 hours aftter the challenge application.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals/dose
- Challenge controls:
- Ten guinea pigs were maintained under identical environmental conditions and distilled water was applied to a naive site on the right side of each animal as a challenge dose. The test substance was applied during challenge.
- Positive control substance(s):
- no
- Key result
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitiser.
- Executive summary:
In a Beuhler assay to evaluate the sensitisation potential the substance (0.25%, 0.5% or 0.75%) was administered topically to guinea pigs (20 animals/concentration) once each week for a 3 week induction period. Twenty seven days after the first induction dose, a challenge dose of the test substance at its highest non-irritating concentration was applied to a naive site on each guinea pig. A naive control group (ten animals) was maintained under the same environmental conditions and treated with the substance at challenge only. The animals were scored for erythma approximately 24 hours and 48 hours after each induction and challenge dose. Based on the results of this study, the substance is not considered to be a contact sensitiser.
- Endpoint:
- skin sensitisation: in chemico
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
Referenceopen allclose all
Sensitisation Response Indices | ||||
Incidence of Positive Response | Severity | |||
24 hours | 48 hours | 24 hours | 48 hours | |
Test Animals | 0/20 | 0/20 | 0.1 | 0.05 |
Naive Control Animals | 0/10 | 0/10 | 0.2 | 0.05 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance is corrosive and so this endpoint can be waived. However, the findings of two reliable in vivo skin sensitisation studies conducted on a structurally similar substance, support the conclusion that classification of the substance is not justified.
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