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EC number: 224-166-0 | CAS number: 4221-80-1
- 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
Based on the results obtained in a Optimization study the test item is considered to possess no skin-sensitizing (contact allergenic) potential in guinea pigs.
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:
- 1979-05-23-1979-06-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (US, 1959)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- The study was conducted in 1979. By this time the LLNA was not an established method yet.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd. Grimston, Hull, England
- Weight at study initiation: 350-440 grams
- Housing: Housed indivually in Macrolon cages, type 3
- Diet: NAFAG No. 830 Gossau SG
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Photoperiod: 10 hours light cycle day - Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- day 0 - day 10
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- day 24
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 30 %
- Day(s)/duration:
- day 34 / 24 h
- No. of animals per dose:
- 10 males and 10 females per group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three different injection procedures+challenge exposure+epicutaneous application:
1. One injection every second day to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of the test item in propylene glycol 100 %.
2. On the first day injection of 0.1 mL were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
3. During the second and third week of the induction period the material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant.
- Test groups: groups of 10 male and 10 females
- Control group: one control group was treated with the vehicle alone
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1: Fourteen days after the last sensitizing injection, a challenge injection of 0.1 mL of a freshly prepared 0.1 % suspension of the test item in propylene glycol 100 % was administered into the skin of the left flank.
- Evaluation (hr after challenge): 24 hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
C.EPICUTANEOUS CHALLENGE:
Ten days after the intracutaneous challenge injection a subirritant dose of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The test substance was applicated in a dose of 30 % in Vaseline. - Positive control substance(s):
- no
- Positive control results:
- no positive control
- Key result
- Reading:
- other: 1st reading (intradermal challenge)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 7
- Total no. in group:
- 19
- Key result
- Reading:
- other: 1st reading (intradermal challenge)
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Key result
- Reading:
- other: 1st reading (epicutaneous challenge)
- Hours after challenge:
- 240
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Key result
- Reading:
- other: 1st reading (epicutaneous challenge)
- Hours after challenge:
- 240
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Interpretation of results:
- GHS criteria not met
Reference
Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of the test item. The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
An optimization study with guinea pigs was performed to investigate the sensitization potential of the test item. The procedure was similar to the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959). During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of test material in propylene glycol. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (1:1). Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % suspension in propylene glycol was administered into the skin of the left flank. Ten days after the intracutaneous challenge injection a subirritant dose of the test compound (30% in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of the test item. The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.
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