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EC number: 614-959-3 | CAS number: 6939-23-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 November - 12 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2011)
- Version / remarks:
- including the most recent partial revisions
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(tert-butylamino)acetic acid hydrochloride
- EC Number:
- 614-959-3
- Cas Number:
- 6939-23-7
- Molecular formula:
- C6H14ClNO2
- IUPAC Name:
- 2-(tert-butylamino)acetic acid hydrochloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- White powder
Test substance storage: In refrigerator (2-8°C) in the dark
Constituent 1
- Specific details on test material used for the study:
- White powder
Test substance storage: In refrigerator (2-8°C) in the dark
Batch #: 11681004
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 3 male New Zealand White Albino rabbits from Charles River France, L’Arbresle Cedex, France. Recognized by international guidelines as the recommended test system. Animals used within the study were between 10-20 weeks old and body weights were between 2-4 kg. Identification earmark.
Conditions:
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 18.5 – 20.4ºC), a relative humidity of 40-70% (actual range: 42 - 71%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Cleaning procedures in the room might have caused the temporary fluctuations above the optimal
maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
Accommodation:
Animals were individually housed in labeled cages with perforated floors and shelters. Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet:
Pelleted diet for rabbits approximately 100 grams per day. Hay and wooden sticks were available during the study period. Free access to tap water.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Animals were treated by instillation of, on average, 28.9 mg (range 28.6 – 29.3 mg) of the test substance (a volume of approximately 0.1 mL) in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball.
- Duration of treatment / exposure:
- 24 hrs.
- Observation period (in vivo):
- Observations were made 1, 24, 48 and 72 hours and 7 and 14 days after instillation.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 3 weeks later, after considering the degree of eye irritation observed in the first animal.
Treatment:
Animals were treated by instillation of, on average, 28.9 mg (range 28.6 – 29.3 mg) of the test substance (a volume of approximately 0.1 mL) in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Immediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. This procedure was repeated in one animal to assess recovery. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20%.
Observations:
Mortality/Viability: Twice daily.
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to instillation) and after the final observation.
Necropsy: No necropsy was performed according to protocol.
Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 and 14 days after instillation of the test substance. The
irritation scores and a description of all other (local) effects were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 155
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 167
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 1 hour
- Remarks on result:
- other: slight dulling of the normal luster of the cornea on Day 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 1 hour
- Remarks on result:
- other: slight dulling of the normal luster of the cornea on Day 1
- Irritation parameter:
- iris score
- Basis:
- animal: 155
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 167
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 155
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 167
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis
- Basis:
- animal: 155
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis
- Basis:
- animal: 167
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis
- Basis:
- animal: 170
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- There was no evidence of ocular corrosion.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Instillation of the test substance resulted in effects on the cornea, iris and/or conjunctivae for all animals. For one animal, the corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 35% of the corneal area). The corneal injury resolved within 7 days. The two other animals
showed slight dulling of the normal luster of the cornea on Day 1. The animal that showed corneal injury also showed iridial irritation (grade 1), which resolved within 7 days. No iridial irritation was observed for the other two animals. All animals showed irritation of the conjunctivae consisting of redness, chemosis and discharge. The irritation of the conjunctivae completely resolved within 14 days. - Executive summary:
Based on these results:
- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), N-butylglycine HCl should be classified as: irritating to eyes (Category 2A).
- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, N-butylglycine HCl should be classified as Irritating to eyes (Category 2) and labeled as H319: Causes serious eye irritation.
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