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Diss Factsheets
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EC number: 946-788-8 | 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- study performed on the analogue substance; the Reliability of the Source Study is 1.
- Justification for type of information:
- Justification for read-across is detailed at section 13.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test was already avaiable, which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- Acid Brown 360 - Similar Substance 01
- IUPAC Name:
- Acid Brown 360 - Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH
- Weight at study initiation: 263 - 350 g
- Housing: in groups of 5 per Type IV Makrolon cage
- Diet: Kliba rabbit and guinea pig maintenance diet (341.4 mm); ad libitum.
- Water: tap water (drinking water with about 2g of ascorbic acid in 10 I water twice a week); ad libitum.
- Acclimation period: not less than 6 days before the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's adjuvant, distilled water
- Concentration / amount:
- Intradermal induction: 5 %
Epicutaneous induction: 50 %
Epicutaneous challenge: 20 %
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freund's adjuvant, distilled water
- Concentration / amount:
- Intradermal induction: 5 %
Epicutaneous induction: 50 %
Epicutaneous challenge: 20 %
- No. of animals per dose:
- Test group: 20
Each control group: 10 - Details on study design:
- RANGE FINDING TESTS:
- Administration volume: filter paper strips of 2 x 2 cm edge length were allowed to take effect in the region of the flank under occlusive conditions.
- Exposure time: the test substance was administered for 2 x 24 hours within a period of 96 hours in order to detect unspecific phenomena which are not based on a sensitization reaction but which might displace the irritation threshold.
- Site of administration: region of the flank, in each case in the same place.
- Number of animals: 4 for each test concentration.
- Readings: approximately 24 and 48 hours after the start of administration.
MAIN STUDYA. INDUCTION EXPOSURE: INTRADERMAL INDUCTION
- No. of exposures: 6 intradermal injections, two at a time, for each animal.
- Exposure period: single application.
- Two control groups: the animals received the same injections, but without the test substance and only with the agent which was used for preparing the suspension.
- Site: shoulder region
- Concentrations: 5 %
B. INDUCTION EXPOSURE: EPICUTANEOUS INDUCTION
- Time schedule: one week after intradermal induction
- Exposure: liquid immersed filter paper strips of 2 x 4 cm edge length under occlusive conditions.
- No. of exposures: 1
- Exposure period: 48 h
- Site: shoulder region, in the same area as previously with the intradermal application.
- Concentrations: 50%
C. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: the first dose approximately 14 days after the epicutaneous induction, the second dose one week later.
1st challenge: test group and control group 1 (control group 2 untreated);
2nd challenge: test group and both control groups.
- Exposure: liquid immersed filter paper strips of 2 x 2 cm length under occlusive conditions.
- Exposure period: 24 h
- Site: intact clipped region of the flank.
- Concentrations: 20 %
- Evaluation: approximately 24, 48, 72 hours after the start of administration.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no effects
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: negative control group 2
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: negative control group 2
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
Any other information on results incl. tables
1/10 animals of control group 1 died 4 days after intradermal induction.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP Criteria not met
- Conclusions:
- The test substance did not show any sensitising potential.
- Executive summary:
The substance was tested for sensitizing effect on the skin of the guinea pig in a Maximization Test based on the method of Magnusson and Kligman according to OECD Guideline 406. After the challenge application, no cutaneous reactions were observed in the animals of the control and test groups at the 24-hour and 48-hour readings.
Therefore, the test substance did not show any sensitising potential and according to the CLP Regulation (EC n. 1272/2008) no classification is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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