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EC number: 235-979-5 | CAS number: 13078-36-9
- 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)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 June 2001-3 August 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study undertaken in non-EU jurisdiction
Test material
- Reference substance name:
- Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate
- EC Number:
- 235-979-5
- EC Name:
- Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate
- Cas Number:
- 13078-36-9
- Molecular formula:
- C14H23N3O10.3Na
- IUPAC Name:
- Trisodium N-carboxymethyliminobis(ethylenenitrilo) tetraacetic acid
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 1) Animals used
Thirty-six white guinea pigs of Std:Hartley strain (body weight and age at receipt: 251 to 283 g, 4 weeks old) were purchased on June 14, 2001, from Japan SLC, Inc. (3371-8 Kotoh-cho, Hamamatsu-shi, Shizuoka Prefecture) and were acclimatized by 11-day preliminary breeding. Thirty animals which were healthy and, in particular, without abnormality in the skin were selected and used in the study.
2) Identification method
At receipt, the animal number at receipt was entered on the right ear using an oil-based black felt-tip pen and, at group allocation, the test animal number was entered on the left ear using an oil-based red felt-tip pen. In addition, the cages and racks were identified by labeling and the animals were housed in the corresponding places.
3) Environmental controlsThe animals were housed individually in stainless wirenet cages (185W x 260D x 175H mm) in small Animal Room 2 controlled at 22 ± 3°C, 55 ± 15% humidity, 10 or more ventilations/hour, and illumination time of 8 hours/day (09:00 to 17:00). The animal room and racks were cleaned and the floor was disinfected with NEO-CHLOR Clean (Shikoku Chemicals Corporation) every day. The cages and trays were exchanged once in 3 weeks and 3 times a week, respectively.
The animals were freely accessed to commercially available solid food RC4 (Oriental Yeast Co., Ltd.) and tap water at Chihayaakasaka-mura from polycarbonate drinking water bottles.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- A supplied
- Day(s)/duration:
- after 0 (intradermal) , and 6 (epicutaneous days
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% w/v
- Day(s)/duration:
- After 21d
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1% w/v
- Day(s)/duration:
- after 21d
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1% w/v
- Day(s)/duration:
- after 21 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Ten
- Details on study design:
- Method of administration in the test substance sensitization group
(1) On the study initiation date (Day 0), a 4 x 6 cm area in the dorsal neck of guinea pigs was clipped using an electric shaver and shaven using an electric razor. In the area of 2 x 4 cm, 3 rows of 2 symmetric sites in the left and right were marked.
(2) 0.05 mL each of 3 dosing solutions prepared previously was injected intradermally (primary induction exposure).
Row (i): 0.1 mL of a water-in-oil type emulsion of distilled water and Freund’s complete adjuvant (FCA) in 1:1
Row (ii): 0.1 mL of the test substance (stock solution)
Row (iii): 0.1 mL of an emulsion of the test substance (stock solution) and FCA.
(3) At 6 days after the study initiation, the dorsal neck was clipped and shaven again, and 0.5 g of vaseline containing 10 w/v% sodium lauryl sulfate (SLS) was applied on the skin of the same area for 24 hours without closure. The area was cleaned with 70% ethanol on the next day.
(4) At 7 days after the study initiation, 0.2 mL of the test substance (stock solution) was applied on the same area, covered with a filter paper 2 x 4 cm in area and with nonpermeable adhesive dressing 4 x 6 cm in area, and fixed with Dermicel Cloth Tape (Johnson& Johnson Medical Inc.) for 48 hours (secondary induction exposure).
(5) At 21 days after the study initiation, a 5 x 5 cm area of the flank was clipped and shaven, and 0.1 mL each of 10, 1 and 0.1 w/v% test substance solutions were applied, covered with adhesive patches 2.5 cm in diameter for a patch test, and fixed with Dermicel for 24 hours (challenge exposure). In case of the positive control substance, one concentration of 0.1 w/v% DNCB solution was applied in the same manner as in the test substance treated group.
- Challenge controls:
- 10 animals
- Positive control substance(s):
- yes
- Remarks:
- DNCB (2,4-dinitrochlorobenzene) in olive oil at 0.1% w/v. 5 test plus 5 control animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%, 1% and 0.1% w/v (irritant controls)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: No irritation observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%, 1% and 0.1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%, 1% and 0.1% w/v (irritant controls)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: No irritation observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%.1% and 0.1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% w/v (irritant controls)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: no skin irritation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- .1% w/v
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% w/v (irritant controls)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: No skin irritiaon
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No abnormal findings in general condition of the animals and and no differences in bodyweight indicative of an effect of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not elicit skin sensitisation in guinea pigs.
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