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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 414-110-5 | CAS number: 1379678-96-2 ORASOL BLAU 761B
- 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:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD test guideline 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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
Test material
- Reference substance name:
- C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
- EC Number:
- 414-110-5
- EC Name:
- C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
- Cas Number:
- 1379678-96-2
- Molecular formula:
- UVCB Substance
- IUPAC Name:
- tetradecan-1-aminium 1-amino-9,10-dioxo-4-[(2,4,6-trimethylphenyl)amino]-9,10-dihydroanthracene-2-sulfonate
- Details on test material:
- - Description: blue powder
- Expiration date of the batch: 01-Apr-1997
-Stability under storage conditions: stable
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 355-449 g
- Housing: in groups of 2 animals per labelled metal cage with wire-mesh floors
- Diet: standard guinea pig diet including ascorbic acid (1600 mg/kg bw; LC 23-B, Hope Farms, Woerden, The Netherlands), ad libitum. Hay (Broekman Institute, Someren, The Netherlands) was provided once a week.
- Water: tap water, diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: 15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 5 % (intradermal), 50 % (epicutaneous)
Challenge: 50 %, 25 %, 10 % (epicutaneous)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 5 % (intradermal), 50 % (epicutaneous)
Challenge: 50 %, 25 %, 10 % (epicutaneous)
- No. of animals per dose:
- Experimental group: 20 animals
Control group: 10 animals - Details on study design:
- INDUCTION - EXPERIMENTAL ANIMALS
Intradermal injections:
On day 1 an area of the dorsal skin from the scapular region (approximately 4 x 6 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 mL/site) were made at the border of a 2 x 4 cm area in the clipped region as follows:
A) Test item dissolved to 5 % (w/w) with propylene glycol.
B) Freunds' Complete Adjuvant, 50:50 with water for injection
C) Test item at twice the concentration used in (A), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.
On day 7, approximately 24 hours prior to the epidermal induction application, the scapular area (approximately 6 x 8 cm) was clipped and shaved free of hair and pretreated with 10 % sodium dodecylsulfate (SDS) in petrolatum. The SDS was massaged into the skin with a spatula without bandaging.
Epicutaneous applications:
Seven days after the intradermal injections, the scapular area (approximately 6 x 8 cm) was again treated. A Scotchpak-non-woven patch ( 2 x 4 cm) mounted on Micropore tape was applied with 0.5 mL of a 50 % (w/w) concentration of the test item in vaseline and placed between the injection sites of the test animals. The Micropore tape was firmly secured, wrapped around the trunk of the animal and secured with Coban elastic bandage. After 48 hours, the dressings and residual test item were removed using a moistened tissue. The epidermal application procedure described ensured intensive contact of the test item even if insoluble in the vehicle used. Reaction sites were assessed for erythema and oedema immediately after removal of the dressings.
INDUCTION - CONTROL ANIMALS
The guinea pigs of the control group were treated in a similar method as described above by the intradermal and epicutaneous inductions with omission of the test item. Reaction sites were assessed and summarised similarly as described above.
CHALLENGE - ALL ANIMALS
The experimental and control guinea pigs were challenged two weeks after the epicutaneous induction application. Hair was clipped and shaved from a 5 x 5 cm area on the left flank of each guinea pig. A volume of 0.05 mL of each of the following three test item concentrations and the vehicle were applied using Square chambers attached to Micropore tape:
a = 50 % (w/w) in vaseline
b = 25 % (w/w) in vaseline
c = 10 % (w/w) in vaseline
d = vaseline
The patches were placed on the shaved area, the Micropore tape firmly secured around the trunk of the animals and held in place by Coban elastic bandage. The dressings and residual test item were removed after approximately 24 hours, using a moistened tissue. The test sites were assessed for redness and swelling 24 and 48 hours after removal of the dressings, using a numerical grading system (modified from Kligman A.M., J. Invest. Dermatol. 47, 1966).
The test sites were re-shaved with an electric razor after the first reading.
All animals were sacrificed at the end of the test period by oxygen/carbon dioxide asphyxiation.
In addition to the skin reactions the following data were recorded:
Mortality/viability/toxicity: once daily
Body weights: prior to start and at termination of the study.
. - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde
Results and discussion
- Positive control results:
- A positive control experiment is carried out once a year as a sensitivity check of the test system. The most recent test was performed in June 1993. The test confirmed sensitivity.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50, 25, 10, 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Remaining test item was dried into the skin after challenge in 1 animal.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50, 25, 10, 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Remaining test item was dried into the skin after challenge in 1 animal..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50, 25, 10, 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Remaining test substance was dried into the skin after challenge in 2 animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50, 25, 10, 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Remaining test substance was dried into the skin after challenge in 2 animals..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50, 25, 10, 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- The control site in 1 animal was stained blue. It was considered possible that some of test item from another square chamber had leaked into the square chamber containing vehicle alone.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50, 25, 10, 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: The control site in 1 animal was stained blue. It was considered possible that some of test item from another square chamber had leaked into the square chamber containing vehicle alone..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50, 25, 10, 0
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- One animal showed red spots in response to the 50 % and one other animal showed red spots in response to the 10 % test item concentration.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50, 25, 10, 0. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: One animal showed red spots in response to the 50 % and one other animal showed red spots in response to the 10 % test item concentration..
Any other information on results incl. tables
Induction Phase:
None of the experimental animals showed erythema or oedema. All animals showed blue discolouration of the treated skin area after the 48 hours occluded epidermal induction exposure, which made skin reading difficult. Seven control animals showed well defined erythema and brown discolouration of the treated skin area after the epidermal exposure. The brown discolouration was possibly caused by the SDS treatment on day 7.
Challenge Phase:
- Control group:
No skin reactions were evident after the challenge exposure. All challenge treated skin sites of all animals showed a blue discolouration, which made skin reading difficult.
- Experimental group:
One animal showed red spots in response to the 50 % and one other animal showed red spots in response to the 10 % test item concentration. All challenge treated skin sites of all animals showed a blue discolouration.
No symptoms of systemic toxicity were observed in main study animals during the study period. There were no incidences of mortality. The mean body weight gain of experimental animals was slightly lower as compared to the respective control values.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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.