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Reaction mass of Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)] [N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]]-, lithium sodium and Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)]-, lithium sodium
EC number: 944-274-8 | 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
Endpoint summary
Administrative data
Description of key information
The analogue test item was tested for skin sensitisation following OECD 406 (Huntsman, 1993). The test item is a mixture of different substances that are closely related by a structural point of view. Under the experimental conditions the test item did not show any skin sensitizing potential.
Based on the read across considerations the same resutls can be applied to Acid Black 220.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study following official guidelines, GLP compliant, performed on a mixture containing the test substance and one analogue substance as pure sodium salts
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA not available as test method at the time of testing
- Species:
- guinea pig
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, initially weighing between 330 to 390 g. 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, kept at a constant room temperature of 22+/- 3°C, at a relative humidity of 30 to 70% and a 12 hours light cycle day.The animals received ad libitum standard guinea pig pellets -NAFAG No. 845, Gossau SG and fresh water. All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office. The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited.
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 0.4 g of a 50% test item concentration
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30% of the test item in vaseline applied on the flank (on a patch 2x2 cm, ca. 0.2g paste per patch)
or only vaseline - Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group
- Details on study design:
- The induction stage was performed in 2 weeks (first week intradermal, second week epicutaneous). During weeks 3 and 4 no treatments were performed. At week 5 the challenge exposure was performed.Induction reactions. After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant and the high test article concentration. Because most of the reactions are treatment related and not compound related, the reactions are only described in special cases in the section of results. Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
The body weight was recorded at start and end of the test. - Challenge controls:
- A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- yes
- Remarks:
- potassium dichromate
- Positive control results:
- 90% of animals at 24 and 48h
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- 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:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was tested for skin sensitisation following OECD 406. Under the experimental conditions the test item does not show skin sensitising properties.
- Executive summary:
The test item was tested for skin sensitisation following OECD 406. Guine pigs (10 males and 10 females) were tested with intradermal and epicutaneous occlusive induction at 5% and 50% of the test item (with adjuvant for the intradermal test, vaseline for the epicutaneous), respectively, in the first two weeks. At week 5 the challenge step was performed with an occlusive patch at 30% of the test item in vaseline. Skin irritation was recorded, together with animals weight.
Under the experimental condition positive skin reactions were noted in 5% of the animals at 24h after patch removal and in 10% of the animals at 48h showed positive reactions. The test item has therefore no skin sensitising properties.
Reference
No erythema nor oedema were recorded for the test group animals.
No test item related effect on the body weight of the animals was observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test item was tested for skin sensitisation following OECD 406. Guine pigs (10 males and 10 females) were tested with intradermal and epicutaneous occlusive induction at 5% and 50% of the test item (with adjuvant for the intradermal test, vaseline for the epicutaneous), respectively, in the first two weeks. At week 5 the challenge step was performed with an occlusive patch at 30% of the test item in vaseline. Skin irritation was recorded, together with animals weight.
Under the experimental condition positive skin reactions were noted in 5% of the animals at 24h after patch removal and in 10% of the animals at 48h showed positive reactions. The test item has therefore no skin sensitising properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.
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