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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)
EC number: 953-115-1 | 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 test substance is considered as a skin sensitizer in albino guinea pigs.
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:
- 12 September 1994 to 2 December 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- 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:
- Code number: FAT-20044/B
Batch-Nr.: 99
Appearance: solid
Solubility: 60 g/l [in water]
Storage: room temperature
Expiration date: 07/99 - Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Remarks:
- 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:
348 to 424 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: standard guinea pig pellets - NAFAG No. 845, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period:
5 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 % / 0.1 ml
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50 %
(patch 2x4 cm; approx. 0.4 g per patch - Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 10 %
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 male and 5 female
- Details on study design:
- Test procedure:
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 % FAT 20044/B in physiological saline (w/v)
- 5 % FAT 20044/B 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
In the test group FAT 20044/B was incorporated in physiological saline and applied on a filter paper 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 20044/B in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 20044/B 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:
- 10 % FAT 20044/B in physiological saline
- physiological saline only
Observations and records
Induction reactions
After removal of the dressing on day 10, irritation of the epidermal application site was observed in 10/10 test group animals.
Challenge reactions
Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
General
The body weight was recorded at start and end of the test.
Interpretation of results
The sensitizing potential of FAT 20044/B was classified according to the grading of Magnusson and Kligman. According to the guide to the labelling of dangerous substances and the criteria for the choice of sentences indicating particular hazards (R sentences) attributed to dangerous substances (Commission Directive 93/21/EEC, April 27, 1993) a test article was classified as a sensitiser in the case where a positive response was noted in at least 30 % of the animals. - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Positive control results:
- All animals treated with 2-Mercaptobenzothiazole puriss showed erythema and almost all showed edema after 24 and 48 h.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Erythema and edema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Erytema and edema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Edema and erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 20044/B is considered as a skin sensitizer in albino guinea pigs.
- Executive summary:
Skin Sensitisation test with FAT 20044/B was carried out using Guinea Pig Maximisation Test according to OECD guideline 406. The test t was performed on 5 male and 5 female guinea pigs in the test group and 5 female guinea pigs in the control group.
Test procedure
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 % FAT 20044/B in physiological saline (w/v)
- 5 % FAT 20044/B 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
In the test group FAT 20044/B was incorporated in physiological saline and applied on a filter paper 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 20044/B in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 20044/B 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:
- 10 % FAT 20044/B in physiological saline
- physiological saline only
Observations and records
Induction reactions
After removal of the dressing on day 10, irritation of the epidermal application site was observed in 10/10 test group animals.
Challenge reactions
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. In a pre-test, reactions were observed with 20, 30, and 50 % FAT 20044/B in physiological saline. In main test, body weights were not affected by treatment. Under the experimental conditions employed, 80 % and 60 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Based on the study results, FAT 20044/B is considered as a moderate skin sensitizer in albino guinea pigs.
Reference
Body weights were not affected by treatment. Under the experimental conditions employed, 80% and 60% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Therefore, FAT 20044/B is considered as a moderate skin sensitizer in albino guinea pigs.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin Sensitisation test with FAT 20044/B was carried out using Guinea Pig Maximisation Test according to OECD guideline 406. The test was performed on 5 male and 5 female guinea pigs in the test group and 5 female guinea pigs in the control group. In a pre-test, reactions were observed with 20, 30, and 50 % FAT 20044/B in physiological saline. In main test, body weights were not affected by treatment. Under the experimental conditions employed, 80 % and 60 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Based on the study results, FAT 20044/B is considered as a moderate skin sensitizer in albino guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the findings in the skin sensitisation study, the test substance should be classified as Skin Sensitiser 1B according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.