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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Aug 2014 - 24 Nov 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: ElmSam:HA
- Sex:
- male
- Details on test animals and environmental conditions:
- Temperature : (20.5-22.8)℃
Relative humidity : (49.0-57.7)% R.H.
Air exchange : (10-20)/h
Light cycle : Light 12h(08:00-20:00)
Dark 12h(20:00-08:00)
Illumination : (150-300)Lux
Cage style : Stainless steel wire cage
Quarantine cage size : (700W x 475D x 200H) mm
Experiment cage size : (540W x 610D x 200H)mm
Animal per cage : Less than 5
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% Ethanol
- Concentration / amount:
- Concentrations:
INDUCTION
Treatment : 25%(w/v) test substance
Negative control : 80% Ethanol
Positive control : 1%(w/v) DNCB
CHALLENGE:
Treatment : 25%(w/v) test substance
Negative control : 25%(w/v) test substance
Positive control : 1%(w/v) DNCB
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% Ethanol
- Concentration / amount:
- Concentrations:
INDUCTION
Treatment : 25%(w/v) test substance
Negative control : 80% Ethanol
Positive control : 1%(w/v) DNCB
CHALLENGE:
Treatment : 25%(w/v) test substance
Negative control : 25%(w/v) test substance
Positive control : 1%(w/v) DNCB
- No. of animals per dose:
- Treatment : 20
Negative control : 10
Positive control : 10 - Details on study design:
- Induction exposure
- No. of exposure : 3
- Exposure period : 6h
- Test groups : 3
- Site : The fur on one flank [(4*6)cm2]
- Frequency of application : day 0, 7, 14
- Duration : induction period continues to day 21
- Observation : Approximately 21hours after removing the patch of the challenge area - Challenge controls:
- Induction exposure
- No. of exposure : 1
- Exposure period : 6h
- Test groups : 3
- Site : The untreated flank of treated and control animals
- Frequency of application : day 27
- Duration : induction period continues to day 29
- Observation : Approximately 21hours after removing the patch of the challenge area - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene(DNCB)
Results and discussion
- Positive control results:
- See table 1, below.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB in Ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%(w/v) DNCB in Ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB in Ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1%(w/v) DNCB in Ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.
Any other information on results incl. tables
Table 1. Evaluation of skin reaction
Group | Number of animals | Observation time | Score of skin reaction | Mean score | Semsotosatopm rate(%) | |||
0 | 1 | 2 | 3 | |||||
Test substance group | 20 | 24 | 20* | 0 | 0 | 0 | 0.0 | 0.0 |
48 | 20 | 0 | 0 | 0 | 0.0 | 0.0 | ||
Negative control | 10 | 24 | 10 | 0 | 0 | 0 | 0.0 | 0.0 |
48 | 10 | 0 | 0 | 0 | 0.0 | 0.0 | ||
Positive control | 10 | 24 | 1 | 5 | 4 | 0 | 1.3 | 90.0 |
48 | 2 | 7 | 1 | 0 | 0.9 | 80.0 |
* : Number of animals showing the score
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- These results indicate that this test substance is considered to have no skin sensitizing potency of Red 620 in guinea pigs by Buehler test under the conditions of this study.
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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