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EC number: 278-079-8 | CAS number: 75147-23-8
- 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
- Study period:
- 24.08 - 01.10.1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Maximisation test was selected because it is regarded as the most sensitive and the preferred method with regard to testing for sensitisation potential.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: <500 g
- Housing: 5 animals in 1 metal cage with wire-mesh floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet: Free access to standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-B, pellet diameter 4mm (Hope farms, Woerden, The Netherlands).
- Water: Free access to tap-water, diluted with decalcified water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45 - 55
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 7.00 a.m. to 7.00 p.m.
- Lighting: Fluorescent light, 4000°K, 120 Lux - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1%
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 10
- Details on study design:
- PRELIMINARY STUDY
- Justification: to select the test concentrations to be used in the main study
- Test substance concentrations: 50, 20, 10, 5, 2, 1 and 0%.
- Method: identical to those during the main study
- Intradermal injections: 2 animals received 2 different concentrations in duplicate (0.1 ml/site) in the clipped scapular region; assessment for irritation 24 and 48 hours after treatment.
- Epidermal application: 2 different concentrations were applied per animal to the clipped flank, using Metallive patches on Medical tape, held in place with Micropore tape and subsequently Coban elastic bandage. After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
MAIN STUDY
INDUCTION
- 3 pairs of intradermal injections (0.1 mL/site): 1:1 w/w mixture of Freunds' Complete Adjuvant with water for injection; undiluted test substance; 1:1 w/w mixture of the undiluted test substance and Freunds' Complete Adjuvant.
- Exposure period: 24 hours
- Site: clipped area: 2 x 3 cm
CHALLENGE
- No. of exposures: 1
- Exposure period: 24 hours
- Site: Metalline patches (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage.
- Concentrations: 0,5 mL
- Evaluation (hr after challenge): 24 and 48 hours: Any signs of erythema and other lesions were recorded.
RE-CHALLENGE
- one week after the first challenge: to clarify the results in the first challenge. The contralateral flank of all animals was similarly treated.
OTHER:
- Randomization: by way of lottery drawing
- Controle group: 10 animals were treated as described for the experimental animals, except that the vehicle was administered.
OBSERVATIONS:
- Mortality: twice daily
- Body weights: Prior to start and at termination of the study.
- Irritation: Skin reactions were graded according to the following numerical scoring systems. Furthermore, a description of all other (local) effects was recorded. Whenever necessary, the treated skin-areas were clipped at least 3 hours before the next skin reading to facilitate scoring.
GRADING IRRITATION REACTIONS
ERYTHEMA AND ESCHAR FORMATION
0: no erythema
1: slight erythema (barely perceptible)
2: well defined erythema
3: moderate to severe erythema
4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
OEDEMA FORMATION
0: no oedema
1: very slight oedema (barely perceptible)
2: slight oedema (edges of area well defined by definite raising)
3: moderate oedema (raised approximately 1 mm)
4: severe oedema (raised more than 1 mm and extending beyond area of exposure)
GRADING CHALLENGE REACTIONS
0: no visible change
1: Discrete or patchy erythema
2: Moderate and confluent erythema
3: Moderate erythema and swelling
4: Intense erythema and swelling
At the end of the study all animals were killed by asphyxiation using an oxygen/carbon dioxide procedure. - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No skin reactions.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin reactions
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No skin reactions.
- Interpretation of results:
- not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not sensitising under the conditions of the current study.
- Executive summary:
The purpose of this study was to evaluate whether the test item induces contact hypersensitivity in guinea pigs after intradermal and epidermal exposure of the animals under the conditions described in this report.
The Maximisation test is selected because it is regarded as the most sensitive and the preferred method with regard to testing for sensitisation potential.
The study was carried out based on the guidelines described in EC Commission Directive 96/54/EC, Part B.6, 'Skin Sensitisation" and OECD No. 406, "Skin Sensitisation", and based on the method described by Magnusson and Kligman.
The test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, 10 animals were intradermally injected with the undiluted test substance and epidermally exposed to the undiluted test substance. Five control animals were similarly treated, but with the vehicle only. Two weeks after the epidermal application all animals were challenged with the undiluted test substance and the vehicle. A second challenge was performed one week later with again the undiluted test substance and the vehicle.
In the first challenge a skin reaction of grade 1 (score 1 accounts for the left side area of the application site) was observed in 1 animal in response to the undiluted test substance concentration, 48 hours after exposure. No skin reactions were evident in the control animals.
In the second challenge, performed one week later, no skin reactions were evident after the challenge exposure in the experimental and control animals.
The skin reaction of grade 1, observed in response to the undiluted test substance in 1 animal in the first challenge phase, is equal to 10% of the animals responding. According to the criteria set out in Annex I (Table 3.4.4.) of the CLP Regulation N° 1272/2008 the substance does not have to be classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For the skin sensitisation endpoint 2 studies are available assessing the potential of the test item to induce contact hypersensitivity in guinea pigs after intradermal and epidermal exposure.
In the study of Huygevoort (1998) a maximisation test was performed based on the OECD 406 and the method of Magnusson and Kligman.
10 animals were intradermally injected with the undiluted test substance and epidermally exposed to the undiluted test substance. Two weeks after the epidermal application all animals were challenged with the undiluted test substance. A second challenge was performed one week later.
Only 1 animal showed possitive skin reactions 1 hour after exposure, however, the effects were fully reversible within 24 hours.
No other reactions were observed in any other animal and therefore, the substance is not skin sensitising.
In the second study (Sterner, 1982) the method of Buehler was used with guinea pigs. Here, 0.1% of the test item in peanut-oil was applied to the clipped skin, covered with a gauze pad and secured with a wrapping of Elastoplast.
Any sign of erythema and edema were recorded after a 3-weeks introduction period and a primary challenge two weeks later.
No animals showed any sign of erythema or edema. This means that the test sample is not considered to cause delayed contact hypersensitivity, and thus not sensitising at 0.1%.
Migrated from Short description of key information:
The substance does not have to be classified according to the criteria set out in Annex I of the CLP Regulation N° 1272/2008.
Justification for selection of skin sensitisation endpoint:
The study is well performed and according to internationally accepted guidelines.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The criteria for skin sensitisation are set out in Tables 3.4.3 and 3.4.4 for category 1A and 1B respectively. Dependant on the assay used to assess the sensitising properties, different criteria are applicable.
For the maximization study the criteria are
- Category 1A: >= 30% responding at =< 0.1 % intradermal induction dose or >= 60% responding at > 0.1 % to =< 1 % intradermal induction dose
- Category 1B: >= 30% to <60% responding at > 0.1 % to =< 1% intradermal induction dose or >= 30% responding at > 1 % intradermal induction dose
The result of the maximization test was 10% of the animals responding to the undiluted test item.
For a Buehler test the criteria are
- Category 1A: >= 15% responding at =< 0.2 % topical induction dose or >= 60% responding at > 0.2 % to =< 20 % topical induction dose
- Category 1B: >= 15% to <60% responding at > 0.2 % to =< 20% topical induction dose or >= 15% responding at > 20 % topical induction dose
The result of the Buehler test was no reactions with 0.1 % test item.
Taking together, the substance does not have to be classified according to the criteria set out in Annex I of the CLP Regulation N° 1272/2008.
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