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Reaction mass ofDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN1}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-) andDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN2}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-)
EC number: 944-038-4 | 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 skin sensitisation potential of the test item was evaluated in two different studies conducted with Guinea pigs and humans, respectively. In a key study, the skin sensitisation potential of the test item was evaluated according toOECD Guideline 406.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. The concentrations for the main study were chosen on the basis of a screening study. Guine pigs were given intradermal injections (into the neck region) on the first week; followed by closed patch exposure over the injection sites one week later and challenge exposure in week 5. Concentrations used were: 5 % for intradermal induction, 50 % for epicutaneous induction and 30% for epicutaneous challenge. 24h and 48h after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. Under the experimental conditions, 5 and 10 % of the animals of the test group showed skin reactions 24 and 48 hours respectively. Based on the EU CLP criteria, the test item can be classified as a "non-sensitiser" to the skin. In a supporting study (Section 7.10.4), the sensitising potential of the test item with respect to humans was evaluated in a repeated insult patch test. In this study, the test item was found to have no irritation or sensitisation potential under the conditions tested.
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
- Study period:
- Study start date: 09 March 1993; Experiment start date - 15 March 1993; Experiment end date - 16 April 1993; Study completion date - 27 April 1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
- Specific details on test material used for the study:
- DETAILS ON TEST MATERIAL
- Code No.of test material: FAT 20037/C
- Batch No.: 9300001
- Additional specification: IRGALAN SCHWARZ BGL ROH TROCKEN
- Contents/Purity: ca. 80 %
- Physical properties: solid; black powder
- Storage conditions: room temperature
- Expiry date: February, 1998 - 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: 330 to 390 g
- Housing: 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: ad libitum, standard guinea pig pellets - NAFAG No. 845, Gossau SG
- Water: ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light cycle day
IN-LIFE DATES: From: 15 March, 1993; To: 16 April, 1993 - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 30 %
- Day(s)/duration:
- Day 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 10 male and 10 female guinea pigs
Control group: 5 males and 5 females guinea pigs. - Details on study design:
- RANGE FINDING TESTS: On each animal, two concentrations of FAT 20037/C were applied simultaneously on the left and right flank. A naive skin site served as control (not reported). 7 days before application of FAT 20037/C two 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.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 1
- Test groups: 1 (10 males and 10 females)
- Control group: 1 (5 males and 5 females)
- Site: the neck region
- Frequency of applications: once
- Concentrations: 5% for the test group
B. INDUCTION EXPOSURE (Epicutaneous)
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: 1 (10 males and 10 females)
- Control group: 1 (5 males and 5 females)
- Site: flank region
- Frequency of applications: once
- Concentrations: 50% for the test group
C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 1 (10 males and 10 females)
- Control group: 1 (5 males and 5 females)
- Site: flank region
- Concentrations: 30 % for the test group
- Evaluation: 24 and 48 hours after the challenge - Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
- Positive control results:
- Reference values with Potassium dichromate (Test No. 920024)
Experimental starting date: November 11, 1992
Experimental completion date: December 11, 1992
The following concentrations of the reference compound and vehicles were used:
Intradermal induction
Concentration of compound: 0.2 %; Vehicle: physiological saline
Epidermal induction
Concentration of compound: 5 %; Vehicle: vaseline
Epidermal challenge
Concentration of compound: 1 %; Vehicle: vaseline
9 out of 10 animals from the test group had positive reactions 24 and 48 hours after the cahllenge exposure, proving the efficiency of the method. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % - intradermal, 50 % epicutaneous, 30 % epicutaneous challenge
- 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:
- 5 % - intradermal, 50 % epicutaneous, 30 % epicutaneous challenge
- 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:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Intradermal induction: 0.2 %; Epidermal induction: 5 %; Epidermal challenge: 1 %.
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Intradermal induction: 0.2 %; Epidermal induction: 5 %; Epidermal challenge: 1 %.
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was classified as a "non-sensitiser" to the skin.
- Executive summary:
The skin sensitisation potential of the test item was evaluated in a study conducted according to OECD Guideline 406. 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, The concentrations for the main study were chosen on the basis of a pre-study. Guine pigs were given intradermal injections (into the neck region) on the first week; followed by closed patch exposure over the injection sites one week later and challenge exposure in week 5. Concentrations used were: 5 % for intradermal induction, 50 % for epicutaneous induction and 30 % for epicutaneous challenge. Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. Under the experimental conditions, 5 and 10 % of the animals of the test group showed skin reactions 24 and 48 hours respectively, after removing the dressings. Based on the EU CLP criteria, the test item can be classified as a "non-sensitiser" to the skin.
Reference
5 and 10 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. However, according to the EU CLP criteria, FAT 20037/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
Control Group | After 24 hours Positive | After 48 hours Positive | |||
Vehicle control | 0/10 | 0/10 | |||
Test article | 0/10 | 0/10 | |||
Test Group | After 24 hours | After 48 hours | |||
Vehicle control | 0/20 | 0/20 | |||
Test article | 1/20 | 2/20 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the substance does not warrant classification for sensitisation according to the CLP-criteria.
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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