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EC number: 402-130-7 | CAS number: 106246-33-7
- 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
Skin sensitization in vivo:
The study was performed 1986 as GLP-test following EC-test method B.6 (Magnusson & Kligman maximisation test) on female guinea pigs. There is no evidence from the test results that the test material is a sensitiser in guinea pigs after induction at a concentration of 10% (injection and topical) and challenge at a concentration of 25%. The vehicle was paraffin oil. In conclusion, the test item is not sensitizing.
Skin sensitization in vitro:
The test item was found to be non-sensitizing in an in vivo skin sensitization study (maximization test) on guinea pigs performed for new substance notification (ELINCS). Therefore, an in vitro skin sensitization study does not need to be conducted.
Respiratory sensitization:
The test item was found to be non-sensitizing in an in vivo sensitization study (maximization test) on guinea pigs, performed for new substance notification (ELINCS). Therefore, a respiratory sensitization study does not need to be conducted.
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:
- September 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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 maximization test on guinea pigs was performed for new substance notification (ELINCS) in 1986, before the LLNA testing method was available.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Sex: 40 females (20 test group/20 control group)
- Source: David Hall Ltd.
- Weight at study initiation: 300 - 350 g
- Housing: gang housingf (5 animals/cage) in aluminium cages
- Diet: Special Diet Services FD1 Guinea Pigs Diet
- Water: ad libitum
- Acclimatisation: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23°C
- Humidity: mean 52% - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10% w/w
- Day(s)/duration:
- epicutaneous application six days after intradermal treatment
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% w/w
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20 - Details on study design:
- RANGE FINDING TESTS:
A preliminary range finding test was carried out to assess suitable concentrations for injection and topical application on 4 previously untreated guinea pigs. Injections were in the shaved scapular region and topical application was on the shaved flanks. Two guinea pigs were subjected to intradermal injections and a further 2 guinea pigs were exposed to topical application of the test substance at various concentrations.
Concentrations investigated were:
- Injections: 10%, 5%, 2% and 1% w/v in paraffin oil
- Topical application: 25%, 10%, 5% and 2% w/v in paraffin oil
MAIN STUDY:
1. Injection Phase
In the main test, hair was shaved from an area 4 em x 6 em across the scapular region of 42 guinea pigs. These animals were allocated as follows:
- Test group: 20 guinea pigs
- Control group: 20 guinea pigs
- Dose ranging: 2 guinea pigs
The test group guinea pigs were each given 6 intradermal injections, 3 in a line each side of and parallel to the mid-line in the shaved region as follows:
- 0.10 ml Freund's Complete Adjuvant (anterior injection)
- 0.10 ml test material (middle injection)
- 0.05 ml test material emulsified with 0.05 ml Freund's Complete Adjuvant (posterior injection)
The test material was injected at a concentration of 10% w/v in paraffin oil. The 20 control group guinea pigs were similarly treated but with paraffin oil replacing the test material. Twenty four hours after injection the treated sites of both test and control groups were assessed for irritancy. The dose ranging guinea pigs were each given a 0.10 ml intradermal injection of Freund's Complete Adjuvant on either side of the mid-line of the shaved scapular region
2. Topical Application
Six days after the injection phase, the injection site of each of the test and control group animals was shaved again and then wetted with 10% aqueous SLS to provoke a mild inflammatory response to enhance the possibility of sensitisation. After 24 h, a 2 cm x 4 cm patch of Whatman No. 3MM filter paper, charged with the test material at a concentration of 10% w/v in paraffin oil, was applied to the pretreated area of each of the test group animals and the patch covered by an overlapping patch of impermeable plastic adhesive tape (Blenderm). The whole area was then firmly bound with Sleek occlusive tape, and the dressing was left in place for 48 h before removal. The control group guinea pigs were similarly treated but with paraffin oil replacing the test material. Twenty four hours after patch removal the treated sites of both test and control groups were assessed for irritancy. The 2 dose ranging guinea pigs were untreated at this stage.
CHALLENGE EXPOSURE:
1. Dose Ranging for Challenge
Before challenging the test animals, a maximum non-irritant concentration of the test material was determined in a preliminary experiment of 2 dose ranging guinea pigs. The animals were pretreated at the induction phase with Freunds Complete Adjuvant only. The test material was applied to the shaved flanks of the guinea pigs for 24 h at concentrations of 10% and 5% w/v in paraffin oil under the same system used for the topical induction.
2. Challenge by Topical Application
Two weeks after the topical induction, both the test and control group guinea pigs were challenged with the test material at a concentration of 25% w/v paraffin oil and the vehicle. A 5 cm x 5 cm area of the left flank was shaved and the test and control materials were applied to the prepared test site on 2 cm x 2 cm pieces of filter paper. The patches were held in place for 24 h by the same method employed for the topical induction after which time they were removed.
Assessment of Response
The degree of response was determined by trained assessors 24 h and 48 h after removal of the challenge patch when an allergic response would be at a peak. Any animal showing erythema at the site of challenge was considered to have shown a positive response. Reactions are scored according to the following scale:
- No visible change: 0
- Slight or discrete erythema: 1
- Moderate and confluent erythema: 2
- Intense erythema and swelling: 3
The sensitisation potential of the test material is rated according to the percentage of animals sensitised, based on Magnusson-Kligman as follows (snjsitizuation grade):
- 0-8%: Grade I (weak)
- 9-28%: Grade II (mild)
- 29-64%: Grade III (moderate)
- 65-80%: Grade IV (strong)
- 81-100%: Grade V (extreme) - Challenge controls:
- Paraffine oil only
- Positive control substance(s):
- no
- Positive control results:
- no positive control tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not sensitizing when applied to guinea pigs.
- Executive summary:
The study was performed 1986 as GLP-test following EC-test method B.6 as Maximization test (Magnusson & Kligman) on female guinea pigs. There i s no evidence from the test results that the test material is a sensitiser in guinea pigs after induction at a concentration of 10% (injection and topical ) and challenge at a concentration of 25%. Vehicle was paraffin oil. In conclusion, the test item is not sensitizing.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The test item was found to be non-sensitizing in an in-vivo skin sensitization study (maximization test) on guinea pigs performed for new substance notification (ELINCS). Therefore, an in-vitro skin sensitization study does not need to be conducted.
Referenceopen allclose all
SIGNS OF IRRITATION DURING INDUCTION:
- Slight to moderate (Grade 1 and 2) reactions in test group
- Slight irritation in control group
EVIDENCE OF SENSITIZATION OF EACH CHALLENGE CONCENTRATION:
- None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The test item was found to be non-sensitizing in an in-vivo sensitization study (maximization test) on guinea pigs, performed for new substance notification (ELINCS). Therefore, a respiratory sensitization study does not need to be conducted.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available the substance is not classified or labelled according to Regulation 1272/2008/EC (CLP).
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