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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Animal study from the period before entry into force of the in-vitro skin irritation requirement.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was subject to the EPA Guidelines for Good Laboratory Practice Standards 40 CFR Parts 160 & 792. The test method was performed according to the internationally accepted EPA guideline 81-5. Test substance data lacked purity.
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 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
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- Appearance: white powder- Lot/batch No.: Not specified- Purity: Not specified- Sample praparation: The test article was weighed, applied to the site on the rabbit and covered with a gauze patch moistened with distilled water.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Ace Animals, Boyertown, PA - Quarantine period of at least one week.- Sex: males- Weight at study initiation: 2.0 -2.2 kg.- identification: cage notation and a uniquely numbered metal eartag.- Housing: individually in wire-meshed cages with bedding. - Diet: Fresh Purina Rabbit Chow (Diet #5321).- Water: ad libitum.- Identification: ear tags and color coded cage cards- Animal room: reserved exclusively for rabbits on acute tests, temperature controlled with a 12 hour light/dark cycle, and kept clean and vermin free.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- 5 % or 0.5 %
- Controls:
- not required
- Amount / concentration applied:
- 100% -Test substance as such
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72 h in total
- Number of animals:
- 6
- Details on study design:
- TEST SITE- Clipping: The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 1 O x 15 cm and remained intact. - Application: TEST SUBSTANCE:- 0.5 g of the test article was placed under a 2.5 x 2.5 cm, moistened 4 ply, surgical gauze patch. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.SCORING:- The test sites were scored for dennal irritation at 30 to 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours following patch removal. - Erythema and edema were scored according to the numerical Draize technique below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. EVALUATION:Erythema & Eschar:- 0= No erythema - 1= Very slight erythema (barely perceptible) - 2= Well defined erythema - 3= Moderate to severe erythema - 4= Severe erythema (beet redness) to slight eschar formation (injuries in depth) Edema: - 0= No edema - 1= Very slight edema (barely perceptible) - 2= Slight edema (edges of area well-defined by definite raising) - 3= Moderate edema (raised approximately 1.0 mm) - 4= Severe edema (raised more than 1.0 mm, extending beyond the area of exposure)- In evaluating the average irritation, scores for individual intact and abraded exposure sites were recorded separately for each of the two scoring time intervals. A total for erythema and eschar formation was added to a total for edema then divided by 4 to yield the individual animal score. - The mean of the three scores was calculated and this score represents the mean primary irritation score. Analysis of Data:- Dermal irritation is the production of reversible inflammatory changes in the skin following exposure to the test article. - Dermal corrosion is the production of irreversible tissue damage to the skin fallowing exposure to the test article.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 minutes
- Score:
- 0.5
- Remarks on result:
- other: Individual scores: 0;0;0;1;1;1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.33
- Remarks on result:
- other: Individual scores: 0,0,0,1,0,1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 + 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Individual scores: 0; 0; 0; 0; 0; 0.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 - 60 minutes
- Score:
- 0.17
- Remarks on result:
- other: Individual scores: 0;0;0;0;0;1.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Individual scores: 0;0;0;0;0;0.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Suttocide®A was determined to be slightly irritating to the skin of rabbits, when administered as such.
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