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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-642-7 | CAS number: 144-83-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
There was one publication(MICHAEL J. IATROPOULOS,et al.)conducted to evaluate the mutagenic potential of Salicylazosulfapyridine (SASP). This study involved 3 genetic endpoints required information for mutagenicity in vitro (ames test, gene mutation test and chromosome aberration test in vitro).
Based on the results of Ames test, test article showed negative mutagenicityfor Salmonella typhimurium and E. coli.This in vitrostudy was performedwith the Salmonella typhimurium(TA 95,TA 100, TA 1535, WP2p and WP2 uvrA-p) at dose levels from 0.4 to 6250 μg/plateboth in the presence and absence of metabolic activationto check the potential of mutagenicity. No mutagenic effect was found.
Inanotherin vitro gene mutation test, there was consistent result with that of Ames test. The test concentration of 0.22 to 700 μg/ml, 50 to 500 μg/ml of the test substance were administrated to mice lymphoma L51784. No mutagenic effect was observed. Thus,itcanbeconcludethattest substance dose not induce the gene mutation in the test condition.
However,Salicylazosulfapyridine (SASP)has induced sister chromatid exchanges and micronuclei(MN) in cultured human lymphocytes without S9 mix.In the in vitro test, cultured human lymphocytes were applied with test substance of 2.5 to 100 μg/ml. SASP had induced sister chromatid exchanges and micronuclei (MN) in cultured human lymphocytes in the absence of liver activation enzymes and in B6C3F1 mice (but not in rats) MN in bone marrow and peripheral RBC.
Onein vivostudy wasperformed to assess the chromosome aberration of the test substance to rat bone marrow cells.500 mg/kg was applied orally to male and female rats. The rats were killed after 6, 24 and 48 hours later. No chromosome damaging was found. Thus, we can conclude the test substancecannot cause chromosome aberrations in in vivo in rat bone marrow cells.
According to Chapter R.7a: Endpoint specific guidance, table R.7.7-5, row 9, no further tests are required since available data (negative results from in vitro gene mutation in bacteria and cytogenicity study in vivoand in vitro) is sufficient to conclude that test article is non-mutagenicy.
Based on the information as above, Salicylazosulfapyridine (SASP)can be considered to be non-mutagenic agent. However, it is insufficient to conclude whether sulfapyridine can the gene mutation effect.
Justification for selection of genetic toxicity endpoint
Available data resulted from in vivo animal test should be given more weight due to the high reliability and relevance to human.
Short description of key information:
Based on the information as above, Salicylazosulfapyridine (SASP)can be considered to be non-mutagenic agent. However, it is insufficient to conclude whether sulfapyridine can the gene mutation effect.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available data resulted from the existing studies, Salicylazosulfapyridine (SASP) can not show the gene mutation effect. However, it is inclusive to make the classification for sulfapyridine.
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.