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EC number: 271-865-1 | CAS number: 68610-44-6
- 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:
- July-September 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No info on batch no. and composition. Well reported and conducted study according to guideline/standards.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across hypothesis is based on “different compounds which have similar properties”.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- The source substance is identified as Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, also known as Sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate (CAS no. 94441-92-6 | EC no. 305-318-6). It is a UVCB substance whose major constituent is sodium 2-ethylhexylimino-di-propionate. Minor constituents are sodium 2-ethylhexylimino-mono-propionate, unreacted acrylic acid and unreacted 2-ethylhexylamine.
- The target substance is identified as Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide (methanol free) (CAS no. 68610-44-6| EC no. 271-865-1). It is a UVCB substance whose major constituents are sodium 2-ethylhexylimino-mono-propionate and sodium 2-ethylhexylimino-di-propionate. Minor constituents are unreacted acrylic acid and unreacted 2-ethylhexylamine.
3. ANALOGUE APPROACH JUSTIFICATION
The target and source substances are essentially the same: both are UVCB substances composed of the exact same constituents with the exact same functional groups (i.e. carboxylic acid groups and secondary/tertiary amine groups). They are expected to have the same ADME profile and to share common mode of action and breakdown products. The target and source substances only differ in the overlapping ranges of their constituents, the content of sodium 2-ethylhexylimino-mono-propionate being especially higher in the target substance. This difference is expected to have no or very limited impact on the potency of effects exerted on exposed living organisms.
4. DATA MATRIX
Cf. read-across justification document attached in §13. Assessment reports. - Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 and 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- No positive control group in the study
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 and 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- No posiitve control group in the study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An alternative adequate study was already available. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 671548/EEC).
Test material
- Reference substance name:
- Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate
- EC Number:
- 305-318-6
- EC Name:
- Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate
- Cas Number:
- 94441-92-6
- Molecular formula:
- C14H26NO4.Na
- IUPAC Name:
- sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate
- Test material form:
- liquid
- Details on test material:
- Date of receipt: 25 June and 28 August 1997
Appearance: clear yellow liquid
Storage: room 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: David Hall Ltd., Burton-on-Trent, UK
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: 300-392 g
- Housing: singly or in pairs in polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 54-78
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:30 July To: 3 September 1997
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100% (undiluted)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75% (v/v) in distilled water
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100%
- No. of animals per dose:
- 20 test and 10 control animals
- Details on study design:
- RANGE FINDING TESTS:
Induction (2 guinea pigs): 25, 50, 75 (v/v) and 100&% (undiluted); 100% was selected
Challenge: not done due to a lack of test material; 100% and 75% (v/v) were selected.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: days 0, 2, 4, 7, 9, 11, 14, 16 and 18
- Test groups: yes
- Control group: no (blank patch)
- Site: left flank
- Frequency of applications: 9 times
- Duration: 6 h each time
- Concentrations: 100% (undiluted)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 h
- Test groups: yes
- Control group: yes
- Site: right flank
- Concentrations: 100% (undiluted) and 75% (v/v)
- Evaluation (hr after challenge): 24 and 48 h after patch removal
- Challenge controls:
- Yes, silimar to test group
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not used.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- No positive control group in the stuyd
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- No positive control group in the study
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, Ampholak YJH-40 is not a sensitiser to guinea pig skin.
- 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 Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 671548/EEC). Twenty test and ten control animals were used for the main study.
Based on the results of a sighting test, the concentration of test material for the induction phase was selected as follows:
Topical Induction: undiluted as supplied;
Based on the results of the induction phases of the study the concentrations of test material for the challenge phase were as follows:
Topical Challenge : undiluted as supplied and 75% v/v in distilled water.
The test material produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to OECD/GHS.
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