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EC number: 203-716-3 | CAS number: 109-89-7
- 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
negative (mouse ear swelling test)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- MEST
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 Dec - 28 Dec 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Principles of method if other than guideline:
- Method: according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114
- GLP compliance:
- not specified
- Remarks:
- Qualite Assurance Statement available
- Type of study:
- mouse ear swelling test
- Justification for non-LLNA method:
- The LLNA method was not available yet by the time the study was conducted.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: C-1039
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature - Species:
- mouse
- Strain:
- CF-1
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: River Breeding Laboratories, Inc. Kingston, New York
- Age at study initiation: Approximately 6-8 weeks
- Weight at study initiation: 20-26 grams
- Housing: housed 2-5/cage
- Diet: Purina Laboratory Chow, #5001, ad libitum
- Water (e.g. ad libitum): Municipal water supply, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 1%
- Adequacy of induction:
- other: maximum non-corrosive concentration
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 50%
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 50%
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Range finding: 10
Sensitization Study: 20 test animals (10 per group)
Irritation Control: 15 (5 per group) - Positive control substance(s):
- yes
- Remarks:
- DNCB (2,4-dinitrochlorobenzene)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test material exhibited no potential to produce sensitization in mice.
- Executive summary:
The test substance was evaluated for dermal sensitization in 20 female CF-1 mice by mouse ear swelling test according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114. Following induction, the challenge was administered by topical application of 50% solution on day 10. A rechallenge was performed 7 days later with a topical application of 50% solution. Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. In contrast, 80% and 100% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system.
Reference
Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. Conversely, 80% and 100% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance was evaluated for dermal sensitization in 20 female CF-1 mice by mouse ear swelling test according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114 (1987. Following induction, the challenge was administered by topical application of 50% solution on day 10. A rechallenge was performed 7 days later with a topical application of 50% solution. Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. In contrast, 80% and 100% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 the substance is not classified for skin sensitization.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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