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Diss Factsheets
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EC number: 274-357-8 | CAS number: 70161-44-3
- 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)
- Remarks:
- This study has been performed before REACH and the limitations for in-vivo testing of sensitization came into force.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 January to 14 February 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Performed under GLP
- Justification for type of information:
- The type of method is one of the officially accepted animal test methods for skin sensitisation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study has been performed before REACH and the limitations for in-vivo testing of sensitization came into force.
Test material
- Reference substance name:
- Sodium N-(hydroxymethyl)glycinate
- EC Number:
- 274-357-8
- EC Name:
- Sodium N-(hydroxymethyl)glycinate
- Cas Number:
- 70161-44-3
- Molecular formula:
- C3H7NO3.Na
- IUPAC Name:
- sodium N-(hydroxymethyl)glycinate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Suttocide A (powder)- Appearance: white powder- Lot/batch No.: 01/13/97 - Purity: not specified
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL- Source: International Specialty Products - Name: Suttocide® A (Powder) - Batch of test material: 01/13/97 - Appearance: White powder - Purity test date: Not specified.- Storage: The test article was stored at room temperature and humidity. - Use in test: The test article was used as received and moistened with 0.1 ml of distilled water prior to dosing.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Ace Animals, Boyertown, PA on 1/07/97- Age at study initiation: born the week of 12/13/96- ID: identified by cage notation and a uniquely numbered metal eartag- Weight at study initiation: 289-351 g- Housing: 1/cage in suspended wire cages- Diet: Fresh Purina Guinea Pig Chow (Diet #5025) ad libitum- Water: ad libitum: ENVIRONMENTAL CONDITIONS- Temperature (°C): controlled- 12 hour light/dark cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 g, of the test article (moistened with 0.1 ml of distilled water
- Day(s)/duration:
- Once a week on the same day each week for a three week period, a total of 3 six hour insults.
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 g, of the test article (moistened with 0.1 ml of distilled water).
- Day(s)/duration:
- 6-hour exposure, fourteen days after the last induction exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 g, of the test article (moistened with 0.1 ml of distilled water).
- Day(s)/duration:
- 6-hour exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY A. INDUCTION EXPOSURE - Exposure period: 6 hours - No. of exposures: 3, once/week on the same day each week for a three week period, a total of 3 six hour insults - Test group (#1): 100% - Control group (#2): Naive control - Site: the left shoulder area using a 25 mm Hilltop Chamber which is designed to keep the test article on a 25 mm area of the site - Occlusion: The chamber was covered with a 8 x 8 cm piece of rubber dental dam and wrapped with non-irritating tape to provide occlusion. After 6 hours, the dams were removed. Any residual test article was cleansed from the sites with distilled water and the sites were dried with soft toweling. - Evaluation (h after induction): 24 and 48 B. CHALLENGE EXPOSURE - No. of exposures: 1 - Time point of challenge: Fourteen days after the last induction exposure - Exposure period: 6 hours - Test group (#1): 100% - Control group (#2): 100% - Site: on the left hip area - Evaluation (h after challenge): 24, 48 and 72 OTHERThe animals in groups 1 and 2 were observed once daily for the duration of the study for mortality, toxicity and pharmacological effects. Body weights were recorded pretest, the day following the last induction application and the day following the challenge application.
- Challenge controls:
- Five animals were untreated for the three week induction period and served as the naive control.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene: induction with 0.4 ml of 0.2% and challenge with 0.4 ml of 0.1%
Results and discussion
- Positive control results:
- Dinitrochlorobenzene (DNCB) is a sensitizer, with a maximum of 7 out of 10 animals responding.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- One animal had diarrhea and one animal had a prolapsed rectum during the observation period. Body weight changes were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article is not a dermal sensitizer.
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