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EC number: 419-800-1 | 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
A reliable guinea pig maximisation test is available conducted in accordance with OECD 406 and GLP. No data is available to assess respiratory sensitisation.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was conducted in 1995 which is prior to the OECD 429 study being available as an acceptable test guideline.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D Hall Ltd, Burton on Trent, UK.
- Age at study initiation: Four to six weeks old
- Weight at study initiation: 400 to 500 g
- Housing: Up to 5 guinea pigs were accommodated in suspended polypropylene cages with open tops and stainless steel mesh fron panels.
- Diet (e.g. ad libitum): SQC FD1 (pelleted) diet was freely available to animals at all times.
- Water (e.g. ad libitum): Mains water was provided ad libitum.
- Acclimation period: At least 5 days
- Indication of any skin lesions: A veterinary inspection was performed prior to study commencement to ensure all animals were suitable for study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70% relative humidity
- Air changes (per hr): At least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1 mL/site
0.5% m/v test substance (site: middle) - Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: Freunds Complete Adjuvant
- Concentration / amount:
- 0.1 mL/site
0.5% m/v test substance (site: posterior) - Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.5 mL of 50% m/m test substance
- Day(s)/duration:
- Days 8, 9 and 10
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 40% m/m test substance
- Day(s)/duration:
- Day 23
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 20% m/m test substance
- Day(s)/duration:
- Day 23
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test group: 20 male guinea pigs
Control group: 10 male guinea pigs - Details on study design:
- RANGE FINDING TESTS:
Screening test for intradermal injection phase: The vehicle and 6 formulations were selected based on solubility trials. On Day 1, 0.1 mL/site of the test substance at concentrations ranging from 0.1 to 5% m/v in corn oil (the maximum practical dose) were applied. Dermal reactions were assessed 24 and 72 hours later.
Screening test for topical application phase: Four formulations incorporating from 5 to 50% m/m in petrolatum (the maximum practical concentration) were selected. Two guinea pigs were prepared by receiving two 0.1 mL intradermal injections of FCA emulsion fifteen days prior to the application of the test substance. The animals on Day 1 were subject to occluded topical exposure of the test substance of 0.2 mL of the test formulations. These patches were left on for 48 hours and then dermal reactions were assessed 24 and 96 hours after removal of the patches.
Screening test for the topical application at challenge: Four formulations were chosen to identify the maximum non-irritant concentration of test substance after topical occlusion. Three guinea pigs were prepared by receiving two 0.1 mL intradermal injections of FCA emulsion eleven days prior to application of the test formulations. Approximately 0.1 mL of the selected formulations was then applied and removed after 24 hours. Dermal reactions were assessed 24 and 48 hours after removal of the chambers.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal exposure and 1 topical application
- Exposure period:
Intradermal exposure: Occured on Day 1
Topical exposure: Occured on Day 8. The animals were occluded for 48 hours.
- Test groups:
Intradermal exposure (each animal at different positions): FCA emulsion alone, test substance 0.5% m/v in corn oil and test substance 0.5% m/v in FCA emulsion.
Topical exposure: 50% m/m test substance in petrolatum
- Control group:
Intradermal exposure (each animal at different positions): FCA emulsion alone, corn oil alone, 50% corn oil in FCA emulsion.
Topical exposure: Petrolatum alone
- Site: Anterior, middle and posterior for the intradermal injections. The dorsum was used for the topical applications.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 23
- Exposure period: 24 hours
- Test groups: 20 and 40% m/m test substance in petrolatum
- Control group: Petrolatum alone
- Site: Applied to the right flank
- Evaluation (hr after challenge): 24 and 48 hours after challenge
- Challenge controls:
- Petrolatum applied to left flank of each animal
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole (MBT)
- Positive control results:
- In the latest positive control study, 8/8 animals provided a positive reponse indicating the test system was working as expected.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% m/m in petrolatum
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- None noted
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% m/m in petrolatum
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- None noted
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40% m/m in petrolatum
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- None noted
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40% m/m in petrolatum
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- None noted
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Control site (petrolatum)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None noted
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Control site (petrolatum)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None noted
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: Positive control group not included on study but conducted seperately.
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The results from the challenge procedure indicated that 35% of the test animals gave a positive response to challenge with the substance indicative of delayed contact hypersensitivity.
Reference
Clinical observations: 1 animal had very red ears on Day 25 but this had resolved by the following day. No other signs were noted.
Bodyweights: Bodyweight increases were recorded for all animals over the study duration.
Challenge response: A patchy erythematous response was apparent 24 and/or 48 hours after bandage removal at the control site of one control and 6 test animals. there were no dermal reactions seen in control animals at sites receiving the test item formulations. The changes at the sites of test substance application in seven of the test animals were more marked than those seen in the controls; patchy to moderate erythema was commonly accompanied by scabs , with desquamation also apparent in one animal . A further two animals showed inconclusive reactions to challenge.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The intradermal induction dose used on study was 0.5% m/v in corn oil. Classification as a skin sensitiser category 1B is warranted when > 30 to < 60% respond at > 0.1% to < 1% of the intradermal induction dose. In this case 35% of animals provided a positive response for sensitisation which means that classification as a skin sensitiser (1B) is warranted in accordance with the CLP Regulation (EC No. 1272/2008, as amended).
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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