Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
- 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 sensatisation: Negative(OECD 406)
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:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- non-LLNA method already available.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Center of Experimental Animals,AMS, Beijing
- Weight at study initiation: 250-300 g
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 °C
- Humidity (%): 60-70%
- Photoperiod (hrs dark / hrs light): 12 hour of light and 12 hour of dark - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Three pairs of intradermal injection of 0.1 mL were given in the test area. The component and concentration of the test subtance were given as below:
Day 0 indution:Intradermal injections
Injection 1: a 1:1 mixture (v/v) FCA/Physiological saline
Injection 2: 25%(v/v) of test substance in the Physiological saline
Injection 3: 25%(v/v) of the test substance in the 1:1 mixture (v/v) of the FCA/Physiological saline
Day 6 Induction: topical application
Because the substance is not a skin irritant, 0.5 mL of 10% sodium lauryl sulphate in Vaseline was painted on the again clipped test area in order to creat a local irritation. - Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 12.5% v/v test substance in physiological saline( 0.2 mL)
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
- Positive control results:
- Erythema and oedema was observed in every animal of positive control group, and the sensitisation rate was 100%.
- Reading:
- 1st reading
- Hours after challenge:
- 27
- Group:
- positive control
- Dose level:
- 2.5 mg/g
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 27
- Group:
- negative control
- Dose level:
- 0.9%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 27
- Group:
- test chemical
- Dose level:
- 12.5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 12.5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 27
- Group:
- test chemical
- Dose level:
- 12.5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 12.5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the study, the test item was considered as non-sensitisation.
- Executive summary:
In the skin sensitization study according to TG OECD 406, 40 male adult puinea pigs were applied with test material(10 animals/group), positive control substance(10 animals/group) and negative control substance(10 animals/group) . There were no erythema, oedema and other skin changed observed in treated and negative control groups after two induction and one challenge exposures. The sensitisation rate was 0%. Under the above test conditions, the substance was considered as not sensitisation.
Reference
There were no erythema, oedema and other skin changed observed in treated and negative control groups after two induction and one challenge exposures.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
In the skin sensitization study according to TG OECD 406, 20 male adult puinea pigs were applied with Reaction Product of 2-Hydroxybenzoic Acid, Styrene and Oxozinc. There were no erythema, oedema or other skin changed observed in treated group after two induction and one challenge exposures. The sensitisation rate was 0%. Under the above test conditions, the substance was considered as not sensitisation.
Justification for classification or non-classification
Based on the available information in the dossier, the substance Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc does not need to be classified for skin sensitisation when considering the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC) and Annex I of Regulation 286/2011/EC.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.