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EC number: 404-290-3 | CAS number: 7216-95-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May-June 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No data on batch number and composition; basic data given, comparable to guidelines/standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- slightly other scorig system used than OECD 406 (1992)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- Readings at more time points than required.
- GLP compliance:
- yes
- Remarks:
- audited in-house
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was carried out before REACH came into force
Test material
- Reference substance name:
- -
- EC Number:
- 404-290-3
- EC Name:
- -
- Cas Number:
- 7216-95-7
- Molecular formula:
- C14H18K5N3O10
- IUPAC Name:
- pentapotassium 2-[bis({2-[bis(carboxylatomethyl)amino]ethyl})amino]acetate
- Details on test material:
- Material was used as delivered.
No data reported on composition and batch number.
Appearance: white powder
Date of receipt: 5 January 1987
Stored at ambient temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, UK
- Age at study initiation: not indicated
- Weight at study initiation: 422-531 g
- Housing: in suspended cages with wire mesh floor and front
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes, but duration not indicated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 May To: 5 June 1987
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- induction:
- intradermal: 1% w/w
- topical: 5% w/w
challenge:
- topical: 0.5 and 0.25% w/w
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- induction:
- intradermal: 1% w/w
- topical: 5% w/w
challenge:
- topical: 0.5 and 0.25% w/w
- No. of animals per dose:
- 20 (test group)
10 (control group) - Details on study design:
- RANGE FINDING TESTS:
induction:
- intradermal: 1% w/w
- topical: 5% w/w
challenge:
- topical: 0.5 and 0.25% w/w
These levels were also tested in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x intradermal, 1x topical
- Exposure period: one week in between
- Test groups: 1
- Control group: 1
- Site: a 4x6 cm area of dorsal skin was clipped free of hair
- Frequency of applications: 3 pairs of intradermal injections, each injection on either side, 1) FCA:water 1:1, 2) test material 1%
w/w in water, 3) test material 1% w/w in FCA:water 1:1, plus a 2x4 patch by topical application
- Duration: single injections and patch for 48 hours
- Concentrations: 1% w/w (injection) and 5% w/w (topical)
B. CHALLENGE EXPOSURE
- No. of exposures: 1x
- Day(s) of challenge: two weeks after topical application
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: 0.5% w/w on one side, 0.25% w/w on other side of the clipped area
- Concentrations: 0.5 and 0.25% w/w
- Evaluation (hr after challenge): 24, 48 and 72 h after challenge
- Challenge controls:
- Similar to test group.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control used.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% and 0.25% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- localised dermal reaction similar to that in controls
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5% and 0.25% w/w. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: localised dermal reaction similar to that in controls.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 and 0.25% w/w
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- dermal reactions slightly more marked than in controls
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 and 0.25% w/w. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: dermal reactions slightly more marked than in controls.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 and 0.25% w/w
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- dermal reactions slightly more marked than in controls
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 and 0.25% w/w. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: dermal reactions slightly more marked than in controls.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The test material did not induce delayed contact hypersensitivity in 18/19 guinea pigs; in one animal an inconclusive result was
obtained. Overall, it was concluded that the test material is not a skin sensitiser. - Executive summary:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Test Guideline 406 and Method B6 of EEC Directive 79/831 EEC.
Twenty test and ten control animals were used for the main study. Based on the results of the sighting test, the concentrations of test material for the induction and challenge phases were selected as follows:
lntradermal induction: 1% w/w in distilled water
Topical induction: 5% w/w in distilled water
Topical challenge: 0.5 and 0.25% w/w in distilled water.
Delayed contact hypersensitivity was not seen in 18/19 guinea pigs; one animal showed an inconclusive result.
The test material was classified as a non-sensitiser to guinea pig skin. The test material was also classified as a non-sensitiser according to EU and GHS labelling regulations. No symbol or risk phrase are required.
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