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EC number: 916-918-8 | CAS number: -
- 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 found to induce skin sensitisation in artificially sensitised guinea pigs (two Maurer optimisation tests).
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:
- From July 16, 1979 to September 6, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Maurer Optimization test in the guinea-pig
- Version / remarks:
- - Maurer Th., Thomann P., Weirich E.G., Hess R. - The Optimization test in the guinea-pig. Agents & Actions 5 (2), 174-179, 1975.
- Predictive evaluation in animals of the contact allergenic potential of medically important substances. Contact Dermatitis 4, 321-333, 1978. Contact Dermatitis 5, 1-10, 1979. - GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Study predates LLNA method
- Species:
- guinea pig
- Strain:
- other:
- Remarks:
- Pirbright-White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Ivanovas, Kissleg (later Charles River Kissleg), Germany
- Age at study initiation: ~10 weeks old
- Weight at study initiation: 375 to 485 g
- Housing: housed individually in Macrolon cages, type 3, assigned to the different groups by means of random numbers.
- Diet : The animals received ad libitum standard guinea pig pellets - NAFAG, N°. 830 supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 55± 5%
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 10 * 0.1 ml of 0.1 % of test substance every other day (except weekends)
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 (Freund's complete Adjuvant) (vehicle : adjuvant =1 : 1). - Day(s)/duration:
- Days 1, 3, 5, 9, 11, 13, 17, 19, 21, 25
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- complete Bacto Adjuvant
- Concentration / amount:
- 0.1 ml of a freshly prepared 0.1 % solution
- Day(s)/duration:
- 14 days after last induction injection
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 3 % of test item in vaseline
- Day(s)/duration:
- 10 days after intradermal challenge for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 per sex per dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE INTRADERMAL
- No. of exposures: 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 item in physiological saline. 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 (vehicle : adjuvant = 1 : 1)
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs, one control group was treated with the vehicle alone
- Site: shaven skin of the right flank (only day 1) and the back
- Frequency of applications: every second day
- Duration: 10 intracutaneous injections (approximately 25 days)
- Concentrations: 0.1 % solution of test substance
B. CHALLENGE EXPOSURE
INTRADERMAL
- No. of exposures: single injection of 0.1 ml
- Day(s) of challenge: Fourteen days after the last induction injection
- Exposure period: single injection
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: skin of the left flank
- Concentrations: 0.1 % solution of test substance in physiological saline
- Evaluation (hr after challenge): Twenty-four hours after the challenge injection
EPIDERMAL
- No. of exposures: one
- Day(s) of challenge: ten days after the challenge injection
- Exposure period: 24 h
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: skin of the left flank
- Concentrations: 3 % of test substance in vaseline
- Evaluation (hr after challenge): Twenty-four hours after patch removal
OTHER:
Bodyweights were recorded immediately before starting the experiment (control values) and at termination of the study. - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml of 0.1 % test item in physiological saline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: intradermal challenge
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% of test item in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- epidermal challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The negative results upon epidermal challenge demonstrate that, in artificially sensitised guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis. The substance is not considered to be a skin sensitiser.
- Executive summary:
Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were only seen after intradermal challenge application of test substance, i.e. when the skin barrier was intentionally by-passed. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.
Reference
No difference between the test and the control group was seen after epidermal challenge application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The Maurer optimization test was used to investigate the sensitizing properties of Basic Red 46. The test was performed on 10 male and 10 female guinea pigs per group of the Pirbright white strain. 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 Basic Red 46 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 material was incorporated in a mixture of the normal vehicle with complete Freund’s 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 Basic Red 46 in physiological saline 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.
Ten days after the intracutaneous challenge injection a sub-irritant dose of the test compound (3 % Basic Red 46 in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The reactions were evaluated 24 h after removing of the bandages according the Draize scoring scale.
Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after intradermal challenge application of Basic Red 46, i.e. when the skin barrier was intentionally by-passed. No differences between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Not classifiable
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