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EC number: 250-054-6 | CAS number: 30112-70-0
- 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:
- August 17, 1994
- 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 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:
- A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.
Test material
- Reference substance name:
- Acid Orange 060 - Similar Substance 01
- IUPAC Name:
- Acid Orange 060 - Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- 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: 338 to 421 g
- Housing: the animals were housed individually in Macrolon cages (Type 3) , assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags,
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light):12 hours light cycle day.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiological saline
- Concentration / amount:
- Pretests
Intradermal Induction:
5% in physiological saline (w/v).
Epidermal Applications (induction and challenge):
50 % in physiological saline.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiological saline
- Concentration / amount:
- Pretests
Intradermal Induction:
5 % in physiological saline (w/v).
Epidermal Applications (induction and challenge):
50 % in physiological saline.
- No. of animals per dose:
- 5 per sex for the test group and 5 of one sex for controls
- Details on study design:
- RANGE FINDING TESTS:
Intradermal Induction
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5 % in physiological saline (w/v).
Since 5 % of test substance in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal Applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of test substance have been examined on separate animals for the determination of the maximum sub irritant concentration :
30 and 50 % in physiological saline.
50 % was the highest possible concentration of the test article in physiological saline. The tested concentrations did not induce erythema reactions.
MAIN STUDY
A. INDUCTION EXPOSURE
DAY 0: INDUCTION, intradermal injections
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % in physiological saline (w/v)
- 5 % in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
DAY 8: INDUCTION, epidermal application
The application site of all animals was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application.
In the test group FAT 20043/D was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
Test group:
- 50% FAT 20043/D in physiological saline
Control group:
- physiological saline only
B. CHALLENGE EXPOSURE
The test and control group animals were tested on one flank with FAT 20043/D in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
Test and control group:
- 50% FAT 20043/D in physiological saline
- physiological saline only - Challenge controls:
- - physiological saline only
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in physiological saline
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in physiological saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
Number of positive animals per group after occlusive epidermal application:
Control Group | After 24 hours | After 48 hours | |||
Vehicle control | 0/10 | 0/10 | |||
Test control | 0/10 | 0/10 | |||
Test Group | After 24 hours | After 48 hours | |||
Vehicle control | 0/10 | 0/10 | |||
Test control | 1/10 | 0/10 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not sensitising
- Executive summary:
Method
The study was performed to determine the skin sensitisation potential of the test substance in rabbits according to OECD Guideline 406 (Skin Sensitisation).
Observations
Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 hours after removing the dressings.
Conclusion
Not sensitising.
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