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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-357-8 | CAS number: 10127-27-2
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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:
- other: EPA, Title 40 Code of Federal Regulations Parts 160 and 792
- Version / remarks:
- August 17, 1989
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 92/69/EEC, July 31, 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- the study was conducted in 1994
Test material
- Reference substance name:
- Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)
- EC Number:
- 233-357-8
- EC Name:
- Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)
- Cas Number:
- 10127-27-2
- Molecular formula:
- C16H11CrN5O8S.Na
- IUPAC Name:
- sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White, Tif: DHP
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, 4332 Stein, Switzerland
- Weight at study initiation: males: mean 383 g (range: 335 - 411 g); females: mean 372 g (reange: 360 - 397 g)
- Housing: individually in Makrolon type 3 cages in fully air-conditioned rooms
- Diet: standard guinea pig pellets, NAFA no. 845, Gossau SG, ad libitum; all batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer
- Water: fresh water, ad libitum; quality of the drinking water according to the parameters of the "Schweizerisches Lebensmittelbuch"
- Acclimation period: 5 days
- Randomisation: cages assigned to different groups by means of random numbes generated by the random number generator
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light):12/12
The sensitivity of the strain is checked once or twice per year wiht a known mild to moderate sensitizer (e.g. mercaptobenzothiazole, hexyl cinnamic aldehyde, potassium dichromate)
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 10 animals in the treatment group
5 animals in the control group
4 animals in the group for the determination of the primary non-irritant concentration - Details on study design:
- RANGE FINDING TESTS:
The concentration for the intradermal injections was selected on account of its local and systemic tolerability in a pretest:
intradermal injection: 5 % (w/v) in physiological saline could be injected and was well tolerated
The concentration for the epidermal applications were selected on account of the primary irritation potential of the test substance. The following concentrations have been examined in two animals (m/f) per concentration for the determination of the maximum subirritant concentration: 10, 20, 30 and 50 % in physiological saline. 50 % was the highest possible concentration of the test item in physiological saline. Reactions were observed with concentations >/= 20 %.
MAIN STUDY
A. INDUCTION EXPOSURE
DAY 0: intradermal injections
3 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 % test substance in physiological saline (w/v)
- 5 % test substance 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: epidermal application
50 % test substance in physiological saline was applied on a filterpaper patch to the neck of the animals (patch 2 x 4 cm, approx. 0.4 g per patch; occluded administration for 48 hours). The control group was treated with the vehicle physiological saline only.
B. CHALLENGE EXPOSURE
DAY 22: epidermal application
the test and control group animals were tested on one flank with 10 % test substance in physiological saline and on the other flank with the vehicle only (patch 2 x 2 cm, approx. 0.2 g per patch; occluded administration for 24 hours)
24 and 48 hours after removal of the dressings the challenge reactions were graded according to the Draize scoring scale.
The body weights were recorded at the start and the end of the study. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Reference values with 2-mercaptobenzothiazole puriss., Test 930018 (January 2 to January 27, 1994):
intradermal induction: 5 % in Oleum arachidis
epidermal induction: 50 % in vaseline
epidermal challenge: 30 % in vaseline
result:
no positive reaction observed in the control group (10 animals)
100 % of the animals in the test group showed positive reactions
Test and results fullfill the requirements for the reliability check of the OECD 406
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs recorded
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs recorded
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Group:
- positive control
- Remarks on result:
- other: The positive control group was not included in this idividual study. Positive controls were performed separately at regular intervals.
Any other information on results incl. tables
No effects on body weight gains or clinical signs were observed.
No clinical signs were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Regulation (EC) no 1272/2008
- Conclusions:
- In a guinea pig maximisation test, the test item caused 70 to 80 % skin reactions in the ten animals of the treatment group and no effects in the five control animals. Based on the results of this study the test item has to be regarded as strong sensitiser according to the grading of Magnusson and Kligman.
- Executive summary:
Testing for sensitizing properties of the test item was performed in female and male guinea pigs according to the method of MAGNUSSON & KLIGMAN. Intradermal induction was performed using 5 % test item in physiological saline and adjuvant/saline mixture 1:1. Dermal induction was carried out with 50 % test item in physiological saline. Challenge treatment were carried out with 10 % test item in physiological saline. At the 48 hours reading 70 % and at the 72 hours reading 80 % of the test animals showed positive skin reactions. The validity of the study was confirmed by negative controls (no skin reactions) and a separate test performed with the reference substance 2 -mercapto- benzothiazole.
Based on the results of this study the test item has to be classified as skin sensitizing category 1B according to the criteria of Regulation (EC) no 1272/2008 (guinea pig maximisation test, >/= 30 % animals responding at > 1 % intradermal induction dose)
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.