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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
In all tested animals with unwashed eyes, a positive response of corneal opacity ≥ 1 and iritis ≥ 1, and both conjunctival redness and conjunctival oedema (chemosis) ≥ 2. The same was found in two out of three animals with eyes washed out after exposure. In all cases, the effects were observed to be reversible within ≤ 14 days.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- 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.
- 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.
- 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to an internationally accepted guideline. Exact purity of the test substance not specified.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Ace Animals, Boyertown, PA on 1/07/97 - Weight at study initiation: 2.0 - 2.3 kilograms (young adults)- System of Identification: Cage number and ear tag.- Housing: individually in cages sized in accordance with bedding.- Diet: Fresh Purina Rabbit Chow (Diet #5321), ad libitum.- Water: fresh tap water, ad libitum. ENVIRONMENTAL CONDITIONS- Light cycle - 12 hours light, 12 hours dark.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 50%-solution
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml equivalent (90 mg)/treated eye
- Duration of treatment / exposure:
- The test substance was placed in one eye of each animal by gently pulling the lower lid away from the eyeball (conjunctival cul-de-sac) to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of material. The contralateral eye remained untreated and served as a control. The eyes of six rabbits remained unwashed. The eyes of the other three were washed with 20 ml of distilled water 30 seconds postdose.
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and on Days 7 and 14 after treatment
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- Scoring and grading of irritation was according to the method of Draize J.H. (1965), Appraisal of the Safety of chemicals in Food, Drugs and Cosmetics - Dermal Toxicity, page 49-52. Association of Food and Drug Officials of the U.S., Topeka, Kansas.
- Irritation parameter:
- overall irritation score
- Remarks:
- No wash out
- Basis:
- animal #1
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 41
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 3 (Conjunctivae)
- Irritation parameter:
- overall irritation score
- Remarks:
- No wash out
- Basis:
- animal #2
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 39
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 3 (Conjunctivae)
- Irritation parameter:
- overall irritation score
- Remarks:
- No wash out
- Basis:
- animal #3
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 49
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 3 (Cornea and conjunctivae)
- Irritation parameter:
- overall irritation score
- Remarks:
- No wash out
- Basis:
- animal #4
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 24
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 3 (Conjunctivae)
- Irritation parameter:
- overall irritation score
- Remarks:
- No wash out
- Basis:
- animal #5
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 39
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 3 (Conjunctivae)
- Irritation parameter:
- overall irritation score
- Remarks:
- No wash out
- Basis:
- animal #6
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 27
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 2 (Cornea and conjunctivae)
- Irritation parameter:
- overall irritation score
- Remarks:
- Washed out
- Basis:
- animal #1
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Max individual irritation score: 2 ((Conjunctivae: discharge)
- Irritation parameter:
- overall irritation score
- Remarks:
- Washed out
- Basis:
- animal #2
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 27
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 3 (Conjunctivae: redness)
- Irritation parameter:
- overall irritation score
- Remarks:
- Washed out
- Basis:
- animal #3
- Time point:
- other: 1 to 14 days
- Score:
- >= 0 - <= 29
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max individual irritation score: 3 (Conjunctivae: chemosis)
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- When administered as a 50% aqueous solution: the degree of ocular irritation was minimal to slight and involved only the conjunctivae. The irritation was also reversible by day 10 after instillation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Most studies reported show only a slight irritation of the skin of test animals exposed to the substance.
Eye irritation:
When administered as a 50% aqueous solution in the key study, the degree of ocular irritation was slight to moderate and involved the cornea, iris and conjunctivae. In all tested animals with unwashed eyes, a positive response of corneal opacity ≥ 1 and iritis ≥ 1, and both conjunctival redness and conjunctival oedema (chemosis) ≥ 2. The same was found in two out of three animals with eyes washed out after exposure. In all cases, the effects were observed to be reversible within ≤ 14 days. Other supporting studies confirmed the slight to moderate eye irritancy of the substance, which was reversible within the observation periods.
Justification for selection of skin irritation / corrosion endpoint:
GLP study according to an internationally accepted guideline with substance applied as such moistened with destilled water.
Justification for selection of eye irritation endpoint:
GLP study according to an internationally accepted guideline.
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
The results of the studies on skin and eye irritation confirm a low to mild potency of irritation due to exposure to the substance. The data of the key study supports classification of sodium n-(hydroxymethyl) glycinate as irritating to eyes category 2. The key studies on skin irritation show that the potency of sodium n-(hydroxymethyl) glycinate to induce irritation is not conclusive to support classification.
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.