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EC number: 278-014-3 | CAS number: 74878-48-1
- 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
The substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Optimization test*, an intracutaneous sensitization procedure similar to the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
*Maurer, Th., Thomann, P., Weirich, E.G. and Hess, R., (1975). The Optimization test in the guinea pig. A method for the predictive evaluation of the contact allergenicity of Chemicals. Agents and Actions Vol. 5 (2), 174-179, 1975 - GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Old test
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 350 to 400 grams.
- Housing: animals were housed individually in Macrolon cages, type 3.
- Diet: standard guinea pig pellets - NAFAG No. 830, Gossau SG - and fresh carrots, ad libitum.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Relative humidity: 55 ± 5 %
- Photoperiod: 14 hours light cycle day. - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 %
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vas. alb.
- Concentration / amount:
- 1 %
- Day(s)/duration:
- 24 hours
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- 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 % solution of test item in physiological saline.
One control group was treated with the vehicle alone ("negative control").
On the first day, injections 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.
During the second and third week of the induction period the test compounds were incorporated in a mixture, of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1).
Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0. 1 % solution of test item was administered into the skin of the left flank.
Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
Before examination, the reaction sites were depilated chemically (Veet, 5 minutes). The two largest perpendicular diameters (in mm) and the increase in the skin- fold thickness (in mm) were measured, and by multiplication of these values a "reaction volume" was obtained (in µl) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control").
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. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% - intradermal challenge
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % - epicutaneous challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- both intradermal and epicutaneous challenge
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not skin sensitising
- Executive summary:
The skin sensitisation potential of test item was investigated in an optimation test proposed by Maurer et al (1973), an intracutaneous sensitization procedure similar to the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test was performed on groups of 10 male and 10 female guinea pigs. 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 % solution of test item in physiological saline. One control group was treated with the vehicle alone.
On the first day, injections 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. During the second and third week of the induction period the test compounds were incorporated in a mixture, of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1). Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of test item was administered into the skin of the left flank. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded. Before examination, the reaction sites were depilated chemically. The two largest perpendicular diameters (in mm) and the increase in the skin- fold thickness (in mm) were measured, and by multiplication of these values a "reaction volume" was obtained (in µl) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control"). 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. Two out of 20 animals were found to have a positive reaction after the intracutaneous challenge injection, while no positive reactions were recorded after the epicutaneous challenge application. Hence, based on the above information, it was concluded that substance was devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.
Conclusion
A response lower than 30 % was recorded, thus the substance does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC) No 1272/2008.
Reference
No differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of test item.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of test item was investigated in an optimation test proposed by Maurer et al (1973), an intracutaneous sensitization procedure similar to the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test was performed on groups of 10 male and 10 female guinea pigs. 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 % solution of test item in physiological saline. One control group was treated with the vehicle alone.
On the first day, injections 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. During the second and third week of the induction period the test compounds were incorporated in a mixture, of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1). Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of test item was administered into the skin of the left flank. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded. Before examination, the reaction sites were depilated chemically. The two largest perpendicular diameters (in mm) and the increase in the skin- fold thickness (in mm) were measured, and by multiplication of these values a "reaction volume" was obtained (in µl) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control"). 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. Two out of 20 animals were found to have a positive reaction after the intracutaneous challenge injection, while no positive reactions were recorded after the epicutaneous challenge application. Hence, based on the above information, it was concluded that substance was 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
According to the CLP Regulation (EC) No 1272/2008, 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.
When an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive.
A response lower than 30 % was obtained in Maurer optimization test.
In conclusion, Fluorescent Brightener 363 does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC) No 1272/2008.
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