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EC number: 205-201-9 | CAS number: 135-57-9
- 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
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Performed as a guinea pig maximisation study in 1987 to GLP. Challenge concentrations appear to have been high, but otherwise considered reliable.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- OECD guideline 406 has been followed.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Weight range 291 - 368 g (average 328 g)
Adaptation period 7 days
Room temperature 22 C +/- 2C
12 hour light - dark cycle
Air exchange 10 times / hour
Humidity approximate 50% - Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction 0.1 ml at 2.5%
Topical induction at 50%
Challenge 1 at 50%
Challenge 2 at 10% (the lower concentration at the second challenge was due to strong reactions at 50%) - Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction 0.1 ml at 2.5%
Topical induction at 50%
Challenge 1 at 50%
Challenge 2 at 10% (the lower concentration at the second challenge was due to strong reactions at 50%) - No. of animals per dose:
- 20 treated animals
10 control - Details on study design:
- Animals were shaved in the area of administration 24 hours before dosing
- Challenge controls:
- Periodic validation with formaldehyde
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 15.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- 9 / 20 with flakey skin / scabbing
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: 9 / 20 with flakey skin / scabbing.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- 17/20 with flakey skin / scabbing
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: 17/20 with flakey skin / scabbing.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- 18/20 with flake skin / scabbing
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: 18/20 with flake skin / scabbing.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- (note same animal with reaction)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: (note same animal with reaction).
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Responses were seen in treated animals and the report differentiates between scabbing and flakey skin and the responses more often associated with positive sensitisers (eg swelling). If the scabbing and flakey skin is disregarded as being a positive effect and if it is accepted that the 50% challenge concentration was too high, then the number of positive responses at the 10% re-challenge are not sufficiently high to warrant classification.
However, the low level of reaction in the control animals receiving the same challenge concentration suggests that the flakey skin and scabbing is indeed a positive response. - Executive summary:
The clinical observations of flakey skin and scabbing were not necessarily considered to be 'positive' signs by the author of the report, but these would have masked any further observations. However, in view of the fact that these clinical signs were only observed in the test group, it is very likely that these are a result of sensitisation and not just irritation.
Reference
The results of the range finder study with intradermal and topical applications resulted in flakey skin at all concentrations in two animals 2 days after treatment. This delayed response was mirrored in the main study at the first challenge, but at the re-challenge, this effect was noted in the first and second 24 hours after administration. Control animals showed little in the way of flakey skin or scabbing, even 48 hours after administration.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Four endpoints included;
Key : Guinea Pig maximised study with very high induction and challenge concentrations. Control animals showed lower levels of reaction to the test-substance treated animals
Supporting, Buehler: Non-maximised, with no adverse effects in treated or control animals
Supporting, human: Low number of reported cases, but not statistically possible in view of limited exposure. No primary data.
Supporting, FCA: non-standard method and some details not reported, but appears to give moderate to strong responses.
Migrated from Short description of key information:
Considered potential sensitiser with reactions seen in test animals stronger than those for the negative controls
Justification for selection of skin sensitisation endpoint:
This was a valid Guinea Pig study performed with a maximisation method
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Considered to be a potential sensitiser on the basis of a Guinea Pig Maximised study that provoked a higher level of skin reaction in the treated group than obvsered in control groups. However, a very high challenge concentration of 50% was used and many animals only showed flakey skin and scabbing consistent with local irritation and not raised skin or redness.
The substance provoked no signs of irritation in a rabbit skin irritation study and caused no effects in a non-maximised Buehler assay at concentrations up to 25%
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