Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-752-1 | 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
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
- Study period:
- 1994-02-14 and 1994-04-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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:
- Direct Red 227:1 – Similar Substance 01
- IUPAC Name:
- Direct Red 227:1 – Similar Substance 01
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright
- 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: 312 to 417 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets -NAFAG No. 845, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal injection: 5% in physiol. saline (w/v)
epidermal applicaion: 50% in physiol. saline
epidermal, challenge: 30% in physiol. saline
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal injection: 5% in physiol. saline (w/v)
epidermal applicaion: 50% in physiol. saline
epidermal, challenge: 30% in physiol. saline
- No. of animals per dose:
- control group: 10
test group: 20 - Details on study design:
- MAIN STUDY
A.1. INDUCTION EXPOSURE (intradermal); on day: 0
- Exposure period: three pairs of indermal injections (0.1 mL per injection) were made simultaneously
- Test groups: adjuvant/ saline mixture 1:1 (v/v), 5% test substance in physiol. saline (w/v), 5% test substance in the adjuvant/saline mixture (w/v)
- Control group: injection: adjuvant/ saline mixture 1:1 (v/v), adjuvant/saline mixture 1:1 (v/v), physiol. saline
- Site: injection: left and right side of the shaved neck
- Duration: single injection
A.2. INDUCTION EXPOSURE (epidermal); on day: 8
- Test group: 50% test substance in physiol. saline
- Control group: physiol. saline only
- Site: neck of the animal
- Duration: 48 hours
B. CHALLENGE EXPOSURE; on day 21
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups and Control group: one flank: 30% test substance in physiol. saline; other flank: physiol. saline alone
- Site: flank
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- All of the animals showed skin reactions after 24 h and 48 h after removing the dressings.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group (vehicle control)
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group (vehicle control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group (test article control)
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group (test article control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group (vehicle control)
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group (vehicle control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group (test article control)
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group (test article control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group (vehicle group)
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group (vehicle group). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group (test article)
- Dose level:
- 30%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 1 animal showed erythema and edema, 4 animals showed only erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group (test article). Dose level: 30%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: 1 animal showed erythema and edema, 4 animals showed only erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group (vehicle control)
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group (vehicle control). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group (test article)
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group (test article). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not skin sensitising
- Executive summary:
The test substance (80 % act. ingr.) was tested in male and female Pirbright guinea pigs by using the Guinea Pig Maximisation Test of Magnusson and Kligman (induction treatment: 5 % given intradermal on day 0, 50 % given epidermal on day 8; epidermal challenge treatment: 30 % on day 21). Body weights were not affected by treatment. Under the experimental conditions employed, 25 % of the animals of the test group showed skin reactions (erythema and/or edema) 24 hours after removing dressing.
On the basis of the results the test material (80 % act. intgr.) is considered to be not skin-sensitising.
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.