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EC number: 218-524-5 | CAS number: 2172-33-0
- 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 vitro
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler test has been selected, because it is one of the recommended tests in the OECD guideline 406, adopted May 12,1981, adapted July 17,1992, as well as in Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992).
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Identification: FAT 46014/G, Solid yellow powder
- Lot/batch number of test material: 258645.16
- Purity: 99.8%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions of test material: Room temperature - Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 283 to 359 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation date: September 22, 1993
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours ligh-cycle day - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Distilled
- Concentration / amount:
- 30%
- Day(s)/duration:
- Week 1 to 3
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 5%
- Day(s)/duration:
- Week 5
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- - 10 male and 10 female guinea pigs in test group.
- 5 males and 5 females in the control group. - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three epidermal occlusive test article applications on the same skin site for 6 hours each (weeks 1 t o 3)
- Exposure period: 3 weeks
- Test groups: Epidermal induction (weeks 1 to 3)
- Control group: Distilled water
- Site: Epidermal
- Frequency of applications: Once a week
- Duration: 6 hours
- Concentrations: 30 % in distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Exposure period: 6 hours
- Control group: Distilled water
- Site: Epidermal
- Concentrations: 5 % in distilled water
- Evaluation (hr after challenge): Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to a modified Draize scoring scale.
This test consists of an induction period with three epidermal occlusive test article applications on the same skin site for 6 hours each (weeks 1 t o 3), a rest period of 13 to 15 days, followed by a challenge period with epidermal occlusive application of the test article for 6 hours (week 5 ).
For all epidermal applications in the test and control group the following self-adhesive and occlusive chamber was used:
Hill Top Chamber"11 full system: 25 mm (Hill Top Research, Inc., Cincinnati , USA)
Approximate volume applied: 0.35 ml/chamber ( fully loaded)
Control group
The control group was treated with the vehicle during the induction period . Like in the test group the maximum sub-irritant concentration of FAT 46014/G was tested during challenge in these animals. - Challenge controls:
- Distilled water
- Positive control substance(s):
- yes
- Remarks:
- potassium-dichromate
- Positive control results:
- After 24 hrs: 11/19 animals showed a positive result.
After 48 hrs: 9/19 animals showed a positive result. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 11
- Total no. in group:
- 19
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 9
- Total no. in group:
- 19
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 46014/G is classified as a sensitiser in albino guinea pigs according to the EEC Classification criteria (Commission Directive 93/21/EEC, April 27, 1993).
- Executive summary:
A key study was conducted to determine the skin sensitisation potential of FAT 46014/G (purity: 99.8 %) in guinea pigs. Test was carried out in GLP compliance and followed the OECD guideline 406. Under the experimental conditions employed, 58 and 47 % of the 19 animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. FAT 46014/G is therefore, classified as a sensitiser in albino guinea pigs according to the EEC Classification criteria (Commission Directive 93/21/EEC, April 27, 1993).
Referenceopen allclose all
One of the male animal was found dead on experimental day 3. Macropathological investigations of this animal showed an ulcer, perforating the small intestine.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A study was performed to determine the sensitising potential of test item FAT 46014/G (with 99.8 % purity) by Buehler test. The substance was tested at 30 % and 5 % concentration in distilled water in induction as well as challenge application. The study was performed as per OECD test guideline and in accordance to GLP. Under the experimental conditions employed, 58 % and 47 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. According to the maximisation grading, FAT 46014/G showed a severe grade of skin-sensitising (contact allergenic) potential in albino guinea pigs. FAT 46014/G is , therefore, classified as a sensitiser in albino guinea pigs according to the EEC Classification criteria (Commission Directive 93/21/EEC, April 27, 1993).
In a supporting study, 50 % and 45 % of the animals of the test groups showed skin reactions at 24 and 48 hours.Hence, FAT 46014/G is classified as a moderate sensitiser (at 5 % concentration) in albino guinea pigs according to the grading of Magnusson and Kligman.
According to the EEC classification criteria (Commission Directive 83/467/EEC, July 29, 1983) FAT 46014/G (purity: 99.8 %) did show a skin-sensitising (contact allergenic) potential in albino guinea pigs.
In another supporting study,skin sensitizing study was carried out to assess the possible allergenic potential of FAT 46'014/H (purity: approx. 32 % (a.i.) when administered to the skin of albino guinea pigs.
For this purpose the " modified Buehler-Test" was used. Twenty test females were induced three times during induction and challenged with the test substance.
Grade of 0 and + were considered to be representative of insignificant responses, whereas those of 1 or greater are considered to be significant. In this study, the test animals treated with the test article at 15% were observed with significant response at 24-or 48-hour challenge reading.
The response of at least 15% positive animals is considered positive "R43" following the commission 93/21/EEC, Commission Directive of April 27, 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.
The results from the first challenge will be not taken into account since the control group I was observed with significant responses
The results for the test substance FAT 46'014/H at the concentration of 15 % is considered to be a non-sensitizer.
Migrated from Short description of key information:
FAT 46014/G is found to be a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
GLP guideline study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
FAT 46014/G is found to be skin sensitiser.
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