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EC number: 239-763-1 | CAS number: 15680-42-9
- 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
The substance was not skin sensitizing in the guinea pig maximization test (OECD 406, GLP) at intradermal and epicutaneous induction at 1 and 10%, respectively.
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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- - 1981 followed, reliability scoring based on 1992 guideline
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA had not yet been invented in 1987.
- Species:
- guinea pig
- Strain:
- other: Pirbright White (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited (Animal Production) 4332 Stein/Switzerland
- Age at study initiation: approx 10 weeks
- Weight at study initiation: 340 to 481 g
- Housing: Housed individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): standard guinea pig pellets NAFAG No. 845, Gossau SG, ad libitum
- Water (e.g. ad libitum): fresh water, ad libitum
- Acclimation period: 6 days (start March 16, 1987)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- single injection
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1%
- Day(s)/duration:
- single injection
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10%
- Day(s)/duration:
- 48h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 3%
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 10/sex
Control group: 10/sex - Details on study design:
- RANGE FINDING TESTS:
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability.
MAIN STUDY
Control group: One side of flank induced with vehicle and challenged with vehicle; other side of flank induced with vehicle and challenged with test substance
Test group: One side of flank induced with test substance and challenged with vehicle; other side of flank induced with test substance and challenged with test substance
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: single exposure (intradermal); 48 hours (epidermal)
- Test groups:
First induction week, intradermal injection:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article in sesame oil
- test article TK 10047 in the adjuvant saline mixture (w/v)
Second induction week, epidermal application:
In the second week of induction the substnace was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours).
The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application).
- Control group:
A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period.
- Site: Intradermal injections into the neck region, followed by closed patch exposure over the injection sites
- Frequency of applications: Single dose exposure (epidermal application)
- Duration: 48h (occluded)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks a f t e r the epidermal induction application
- Exposure period: 24 hours
- Test groups: The animals were tested on the flank in vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration).
- Control group: During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Site: flank
- Concentrations: 3% in vaseline (epidermal challenge)
- Evaluation (hr after challenge): 24 and 48 hrs
Challenge reactions: Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale (Appraisal of the Safety of chemicals in Foods, Drugs and Cosmetics (1959), The US Association of Food and Drug Officials (AFDO).
General: The sensitising potential was classified according to the grading of Magnusson and Kligman.
Maximization grading:
Sensitization rate (%) - Grade - Classification
(0 – 8) - I - weak
(9 – 28) - II - mild
(29 – 64) - III - moderate
(65 – 80) - IV - strong
(81 – 100) - V - extreme - Challenge controls:
- During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain was checked every six months with Paraphenylene-diamine or Potassium-dichromate.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control (induced with vehicle, challenged with test article)
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control (induced with vehicle, challenged with test article)
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
Reference
Body weight development was not affected by the treatment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The substance was tested in a GLP-compliant guinea pig maximization test following OECD guideline 406. Induction concentrations were 1% in sesame oil (intradermal) and 10% (epidermal.). The challenge concentration was 3%. There were two control groups: In one group, challenge was done with the vehicle, in the other, the test substance was used.
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability.
Overall, no skin reactions were observed - neither in the control groups nor in the test group.
The test material was not characterized for particles in the nano-size range.
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. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.
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