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EC number: 939-682-8 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- 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 (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before LLNA was required as the first choice method for in-vivo testing.
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L'Arbresle, France
- Age at study initiation: 1 - 2 months old
- Weight at study initiation: males 332 - 401 g; females 335 - 396 g
- Housing: individually
- Diet (e.g. ad libitum): 106 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Millipore-filtered (0.22 micron) drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: 0.5, 1, 2.5, 5, 10 and 25 % (w/w) intradermal; 10, 25, 50 and 100 % (w/w) epicutaneous;
Challenge: 0.5, 1, 2.5, 5, 10, 25, 50 and 100 % (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: 0.5, 1, 2.5, 5, 10 and 25 % (w/w) intradermal; 10, 25, 50 and 100 % (w/w) epicutaneous;
Challenge: 0.5, 1, 2.5, 5, 10, 25, 50 and 100 % (w/w)
- No. of animals per dose:
- 20 (10 males, 10 females); 10 control (5 males, 5 females)
- Details on study design:
- RANGE FINDING TESTS:
For both the preliminary and the main test, the application sites of all animals were clipped before intradermal injections and topical applications of the induction phase, clipped and shaved before topical applications of the challenge phase (each flank), shaved before the 48-hour reading of the challenge phase and before the 24-hour reading of the induction phase (preliminary test), and clipped before skin sampling (for the concerned animals).
By intradermal route: Concentrations of 0.5, 1, 2.5, 5, 10 and 25 % (w/w) were intradermally injected in a volume of 0.1 mL into the interscapular region, local reactions were evaluated approximately 24, 48 hours and 6 days after the injections.
By cutaneous route: Under the conditions of the induction phase concentrations of 10, 25, 50 and 100 % (w/w) were applied epicutaneously to the shaved skin on a filter paper (approx. 8 cm²) fully-loaded with the dosage preparation. The filter paper was held in place by means of an occlusive dressing for 48 hours, the cutaneous reactions were evaluated 24 and 48 hours after removal of the dressing.
Under the conditions of the challenge phase concentrations of 0.5, 1, 2.5, 5, 10, 25, 50 and 100 % (w/w) were loaded onto the filter paper of a Finn Chamber. The chamber was held in place by means of an occlusive dressing for 24 hours, cutaneous reactions were evaluated 24 and 48 hours after the removal of the dressings.
The following criteria were used for the selection of concentrations: they should be well-tolerated systemically and locally, intradermal injections should cause moderate irritant effects (no necrosis or ulceration of the skin), cutaneous application for induction should cause at most weak or moderate skin reactions or should be the maximal practicable concentration, cutaneous application for challenge should be the highest concentration which does not cause irritant effects.
As the test substance demonstrated irritant characteristics during the pre-test, a topical application of sodium lauryl sulfate was not necessary on day 7.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: on day 1 (intradermal) and 8 (epicutaneous, for 48 hours)
- Test groups: intradermal: FCA + saline; test substance + saline; test substance + FCA + saline; epicutaneous: test substance in purified water
- Control group: FCA + saline; Saline; Vehicle + FCA + saline
- Site: intradermal: into each side of the interscapular region (3 pairs of sites); epicutaneous: same sites
- Frequency of applications: 7 days
- Duration: day 1 to 10
- Concentrations: intradermal: 0.5 % (w/w) test substance; epicutaneous 25 % (w/w)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: for 24 hours
- Test groups: test substance in purified water and vehicle, respectively
- Control group: test substance in purified water and vehicle, respectively
- Site: test substance: posterior right flank; vehicle: posterior left flank
- Concentrations: 1 % (w/w)
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressing - Challenge controls:
- not performed
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
- Positive control results:
- The sensitivity of the experimental technique is regularly assessed using a known moderate sensitizer. In a recent study performed under the experimental conditions of the testing laboratory, the strain of guinea pigs used showed a satisfactory sensitisation response in 100 % of the animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema (grade 1), dryness of the skin in one animal
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1), dryness of the skin in one animal.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- moderate erythema (grade 2), dryness of the skin in both animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: moderate erythema (grade 2), dryness of the skin in both animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema (grade 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: discrete erythema (grade 1).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema (grade 1), dryness of the skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: discrete erythema (grade 1), dryness of the skin.
Any other information on results incl. tables
In the control group, a discrete erythema was observed on the right flank (test item application) of 3/10 animals at the 24-hour reading and persisted in one of them, associated with a dryness of the skin, at the 48-hour reading.
In the treated group, on the right flank, a discrete erythema (grade 1) was noted in 5/20 animals at the 24-hour reading; at the 48-hour reading, a moderate erythema (grade 2) was observed in 2/20 animals. A dryness of the skin was also noted in 1/20 and 2/20 animals at the 24- and 48-hour readings, respectively.
Conclusion:
The higher number of animals demonstrating cutaneous reactions (5/20, corresponding to 25 %) in the 24-hour reading have to be ascribed to the irritant character of the test substance and must be considered as local irritation reaction. Even this number does not exceed the threshold of 30% positive reactions, demanded by the underlying OECD guideline for sensitisation tests with adjuvant, required to consider a test substance as sensitising.
After 48 hours, only 2/20 animals (10%) with cutaneous reactions remain, which have to be considered as sensitised.
Under the experimental conditions chosen, using the maximisation method of Magnusson and Kligman, the test item finally induced cutaneous reactions in 2/20 (10%) guinea pigs. According to the criteria of Council Directive 67/548/EEC (DSD) and the CLP regulation the test item does not need to be classified as sensitising to the skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified
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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