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EC number: 254-663-8 | CAS number: 39872-57-6
- 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 sensitisation (OECD 406): not sensitising
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:
- 21 Aug - 14 Sep 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No data on analytical purity of test substance given. Test substance concentration used for intradermal induction (1%) did not induce mild to moderate skin irritation. No data for positive control results reported.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12 May 1981
- Deviations:
- yes
- Remarks:
- No data on analytical purity of test substance given. Test substance concentration used for intradermal induction (1%) did not induce mild to moderate skin irritation.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was done before LLNA as first-choice method for in-vivo testing was set into force.
- Species:
- guinea pig
- Strain:
- other: Pirbright white Bor: DPHW
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF
- Weight at study initiation: 300 - 412 g (males) and 315 - 369 g (females)
- Housing: 5 animals per cage in Macrolon type IV cages on LIGNOCEL
- Diet: pelleted guinea pig diet (Ssniff G-Alleindiät für Meerschweinchen, Ssniff Spezialdiäten GmbH, Soest Germany), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- on Day 0; single injection
- Adequacy of induction:
- other: next lower dose of concentrations causing severe erythema (2.5%)
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- on Day 7; 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- on Day 21; 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Range-finding test: 2 males and 2 females
Main study: 10 males and 10 females for test and control group - Details on study design:
- RANGE FINDING TESTS:
The aim of the range finding test was to find out the highest concentrations which cause mild-to-moderate skin irritation after intracutaneous and epicutaneous administration and the highest non-irritant concentration after epicutaneous administration. For the intradermal tolerance test 2 male and 2 female animals were treated intradermally with test substance concentration of 0.5, 1, 2.5 and 5% diluted in a mixture of FCA and water. Skin reactions were recorded after 48 h. Since test substance concentration of 2.5 and 5% produced local ulceration and discoloration, 1% concentration was chosen for the main study. For the epicutaneous tolerance test two animals each were treated with test substance concentrations of 25 and 50% in peanut oil or 100%, repectively. Applications were made under occlusive dressings and skin reactions were recorded after 48 h. Since the test substance caused slight to moderate erythema at a concentration of 100%, this concentration was chosen for epicutaneous induction in main study. Next lower test substance concentration of 50% causing no skin reactions was chosen for challenge of main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: 0.1 mL 1:1 mixture (w/w) FCA/water
Injection 2: 0.1 mL 1% (w/v) test substance in peanut oil
Injection 3: 0.1 mL 1% (w/v) test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: 100% test substance
- Control group:
Intradermal (3 pairs of injections):
Injection 1: 0.1 mL 1:1 mixture (w/w) FCA/water
Injection 2: 0.1 mL peanut oil (vehicle)
Injection 3: 0.1 mL 50% mixture (w/w) arachis oil emulsified with FCA
Epicutaneous: 100% peanut oil (vehicle)
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: Day 1 (intradermal) and Day 8 (epicutaneous)
- Duration: Day 1 - 8
- Concentrations: intradermal: 1%; epicutaneous: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test subsatance and vehicle
- Control group: test substance and vehicle
- Site: left flank (test substance), right flank (vehicle)
- Concentration: 50%
- Evaluation (hr after challenge): 24 and 48 h after challenge patch removal
- Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- The reaction to the positive control substances 2.4 dinitrochlorobenzene (extreme sensitizer) and benzocaine (moderate sensitizer) is tested periodically (last test performed in April 1991).
- Positive control results:
- The positive control group was not carried out concurrently with this study but is tested periodically. The last test with an acceptable level of response to each of the positive control substances was performed in April 1991.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Group:
- positive control
- Remarks on result:
- other: tested periodically, but no results given
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the guinea pig maximisation test the test substance revealed no sensitising properties.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of the test substance was investigated in a guinea pig maximisation test (GPMT test) according to OECD Guideline 406 and in compliance with GLP (1991). Based on the results of an range-finding study, animals were exposed intradermally and epicutaneously to the test substance (1% in peanut oil and 100%, respectively) or the vehicle. Two weeks later a challenge exposure with the test substance (50% in peanut oil) and vehicle for 24 h was performed. No skin reactions occured 24 h or 48 h after challenge in any animal. Therefore, the test substance is considered to be non sensitising to the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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