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EC number: 251-780-6 | CAS number: 33996-33-7
- 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
Oxaceprol produced a 0 % (0/10) sensitisation rate and is classified as a non-sensitiser to guinea pig skin under the conditions of the test.
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:
- 2001-03-09 to 2001-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study perforemd in 2001.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyowa Hakko Kogyo Co., Ltd. / lot 000703
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
For the purpose of the intradermnal phase of the study the test material was freshly prepared in distilled water and for the topical phase of the study the test material was freshly prepared in 90 % aqueous ethanol. - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, Staffordshire, UK
- Age at study initiation: ca. 8 - 12 weeks
- Weight at study initiation: 300 - 450 g
- Housing:singly or in pairs in soild-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 ml of 1 % (w/w) formulation
- Day(s)/duration:
- 21 d
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 90 % aqueous ethanol
- Concentration / amount:
- a square filtre paper 20 mm x 20 mm , saturated with the test material formulation, 25 % (w/w)
- Day(s)/duration:
- 2 d
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10, 5 for control
- Details on study design:
- RANGE FINDING TESTS:
The concentration of test materia to b eused at each stage of the main study was determined by 'sighting tests' in which gropus of guinea pigs were treated with various concentrations of test material.
Selection of concentration for intradermal induction: Intradermal injections (o.1 ml/injection site) in concnetrations of 1 5 and 5 % in distilled water. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systematically, was selected for the intradermnal indusction stage of the study.
Selection of concentration for topical induction: 2 guinea pigs (intradermally injected with Freund's Complete Adjuvant 14 d earlier) were treated with 4 preparations of the test material (25 %, 10 %, 5 % and 2 % in 90 % aqueous ethanol). The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
Selection of concentration for topical challenge: 4 preparations of the test material (25 %, 10 %, 5 % and 2 % in 90 % aqueous ethanol) were applied to 2 guinea pigs for an exposure period of 24 h. The highest non-irritant concentration and one lower concentration were selected for the topical challenge of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
A row of 3 injections (0.1 ml each) was made on each side of the mid-line into a 20 mm x 40 mm area. The injections were:
1. Freund's Complete Adjuvant plus distilled water 1 : 1
2. 1 % formulation of the test material in distilled water
3. 1 % formulation of the test material in distilled water plus reund's Complete Adjuvant in distilled water, ration 1 : 1.
24 and 48 h after intradermal injection the degree of erythema at the test material sites was evaluated.
On day 7 the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the test material formulation. A filtre paper saturated with the test material formulation ( 25 % in 90 % aqueous ethanol) was applied and held in place The occlusive dressing was kept in place for 48 h. The degree of erythema and odeema was quantified 1 h and 24 h after remioval of the test patches.
B. CHALLENGE EXPOSURE
Treatment was on day 21. A filtre paper saturated with the test material formulation ( 25 % in 90 % aqueous ethanol) was applied to the right shorn flank of each animal. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 10 % in 90 % aqueous ethanol was similarily applied to a skin site on the left shorn flank. All patches were held in place.
After 24 h, the dressing was carefulyl removed and discarded. The challenge sites were swabbed with cotton wool soaked in diethyl ether to remove residual material.
The degree of erythema and odeema was quantified 24 h and 48 h after remioval of the challenge dressing.
OTHER:
Any other reactions were also recorded. - Challenge controls:
- 10 % in 90 % aqueous ethanol
- Positive control substance(s):
- yes
- Remarks:
- Historical positive control data with 2-Mercaptobenzothiazole and alpha-Hexylcinnamaldehyde
- Positive control results:
- Valid
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % (w/w) in 90 % aqueous ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % (w/w) in 90 % aqueous ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 % (w/w) in 90 % aqueous ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 % (w/w) in 90 % aqueous ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oxaceprol produced a 0 % (0/10) senistiation rate and is classified as a non-sensitiser to guinea pig skin under the conditions of the test.
- Executive summary:
The skin sensitiastion potential of oxaceprol was assessed in a test according to OECD 406 (guinea pig maxiisation test of Magnussen and Kligman) in 2001. Oxaceprol produced a 0 % (0/10) sensitisation rate and is clasified as a non-sensitiser to guinea pig skin under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Oxaceprol produced a 0 % (0/10) sensitisation rate and is classified as a non-sensitiser to guinea pig skin under the conditions of the test.
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