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EC number: 228-995-9 | CAS number: 6388-26-7
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 22 to December 16, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig maximisation test was available.
Test material
- Reference substance name:
- Direct Green 026
- IUPAC Name:
- Direct Green 026
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 393 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 h light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- and in adjuvant/saline mixture
- Concentration / amount:
- 5 %, 0.1 ml
- Day(s)/duration:
- day 0
- Adequacy of induction:
- other: well-tolerated
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 %, 0.4 g
- Day(s)/duration:
- day 8
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 30 %, 0.2 g
- Day(s)/duration:
- day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10/sex
- 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 was used for intradermal injection: 5 % in physiological saline (w/v).
Since 5 % 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 concentrations of 30 % and 50 % in vaseline were examined on separate animals for the determination of the maximum subirritant concentration.
50 % in vaseline was the highest applicable concentration of the test article. Erythema reactions were observed with 50 % test substance in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL
- No. of exposures: 1
- Exposure period: day 0 (intradermal)
- 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
- Site: left and right side of the shaved neck
A. INDUCTION EXPOSURE - EPICUTANEOUS
- No. of exposures: 1
- Application: day 8, with filterpaper patch (2 × 4 cm; occluded)
- Exposure period: 48 h
- Pretreatment: the application site was pretreated with 10 % sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application.
- Test group: 50 % in vaseline
- Control group: vaseline only
- Site: neck
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 21
- Exposure period: 24 h
- Test group: 30 % in vaseline
- Control group: vaseline only
- Site: flank
- Concentrations: 30 %
- Evaluation: 24 and 48 h after removing the dressing
- Positive control substance(s):
- yes
- Remarks:
- with 2-mercaptobenothiazole, August 1993
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: positive control mercaptobenzothiazole was tested once a year, not concurrent to the test.
- Remarks:
- The following concentrations of the reference compound and vehicles were used: Intradermal induction Concentration of compound: 5% Vehicle: Oleum arachidis Epidermal induction Concentration of compound: 50% Vehicle: vaseline Epidermal challenge Concentration of compound: 30% Vehicle: vaseline
Any other information on results incl. tables
Evaluation of the primary skin irritation potential
Procedure: on each animal, 2 concentrations of test substance were applied simultaneously on the left and right flank. A naive skin site served as control (not reported). 7 days before application of test substance, 2 pairs of intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs.
animal/sex | 24 h | 48 h | ||||||
30 % | 50 % | 30 % | 50 % | 30 % | 50 % | 30 % | 50 % | |
er. | oed. | er. | oed. | er. | oed. |
er. |
oed. |
|
1 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 female |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
er. = erythema
oed. = oedema
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non skin sensitising in a guinea pig maximisation test.
- Executive summary:
Method
Guinea pig maximisation test using 20 animals (10/sex) in test group and 10 animals (5/sex) in control group. A pretest was conducted to choose test substance concentration for intradermal and epidermal applications.
Intradermal induction was done on day 0 using a 5 % solution of test substance in physiological saline and adjuvant/saline mixture.
Epidermal induction was done on day 8, applying test substance at 50 % in vaseline for 48 h. Challenge was done on day 21, applying test substance at 30 % in vaseline for 24 h. Readings were done 24 and 48 h after removal of the dressings.
Results
5 % test substance in physiological saline was well tolerated; 50 % in vaseline was the highest applicable concentration, causing erythema reactions.
Upon challenge on day 21, 2/20 positive responses were reported in test group after 24 h, which were no longer evident after 48 h..
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