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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
Endpoint summary
Administrative data
Description of key information
Skin irritation:
- Experimental in vivo study (OECD 404) on the analogue substance "Sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate", CAS 94441 -92-6.
Eye irritation:
- Experimental in vivo study (OECD 405) on the analogue substance "Sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate", CAS 94441-92-6.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18-28 September 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Linxe.
- Age at study initiation: 12 weeks
- Weight at study initiation:2.42-2.68 kg
- Housing: Individual box
- Diet (e.g. ad libitum): ad libitium
- Water (e.g. ad libitum): ad libitium
- Acclimation period: 5 days
- Other: Albino rabbits, female
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 31-55 %
- Photoperiod (hrs dark / hrs light): (12/12) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 on an undamaged skin area of one flank of each animal.
- Type of wrap if used: patch with strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: treated area was rinsed with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: scored in accordance with OECD404 - Irritation parameter:
- erythema score
- Basis:
- animal: Mean of animals 1, 2 and 3
- Remarks:
- Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: Mean of animals 1, 2 and 3
- Remarks:
- Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No cutaneous reactions (erythema and oedema) were observed (1, 24, 48 and 72 hours).
- Other effects:
- No other effects were observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritating potential of the substance was investigated in a dermal skin irritating study which was performed in accordance with OECD404 and under GLP conditions. Based on the result the test item does not need to be classified in accordance with the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008?EC, under the conditions of this study.
- Executive summary:
The skin irritating potential of sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate was investigated in a dermal skin irritating study which was performed in accordance with OECD404 and under GLP conditions. The test material was applied to the shorn skin of 3 (female) New Zealand White albino rabbits at a dose of 0.5 mL under semi-occlusive dressing during 4 hours. No cutaneous reactions (erythema and oedema) were observed. Based on these results, the test substance does not need to be classified in accordance with the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008?EC, under the conditions of this study.
- Endpoint:
- skin irritation: in vivo
- 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 source
- Irritation parameter:
- erythema score
- Basis:
- animal: Mean of animals 1, 2 and 3
- Remarks:
- Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: Mean of animals 1, 2 and 3
- Remarks:
- Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
Referenceopen allclose all
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
- Study period:
- 24 September -02 October 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Linxe
- Age at study initiation: 18 weeks
- Weight at study initiation: 3.20-3.84 kg
- Housing: Individual box
- Diet (e.g. ad libitum): ad libitium
- Water (e.g. ad libitum): ad libitium
- Acclimation period: 5 days
- Other: Albino rabbits (male)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 °C
- Humidity (%): 36-70 %
- Photoperiod (hrs dark / hrs light): (12/12) - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0,1 mL of test item was instilled into conjunctival sac of one eye, the other eye remained untreated as control.
- Duration of treatment / exposure:
- Single dose.
- Observation period (in vivo):
- 1, 24, 48, and 72 hours following treatment and daily thereafter up to 8 days after treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: In accordance with OECD 405
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 1.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The conjunctiva reactions observed during the study have been moderate, and totally reversible in the three animals: a moderate redness, noted 24 hours after the test item instillation and totally reversible between day 6 and day 8, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between day 3 and day 6.
- Other effects:
- No other effects were observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye irritating potential of Amphotensid EH was investigated in an acute eye irritation study, which was performed according to OECD 405 and under GLP conditions. Based on the results, the test item does not need to be classified according to the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008, under the conditions of this study.
- Executive summary:
The eye irritating potential of Amphotensid EH was investigated in an acute eye irritation study, which was performed according to OECD 405 and under GLP conditions. Three male albino New Zealand White rabbits were administered a single ocular dose of 0.1 ml of the test substance and observed up to eight days after instillation. Moderate conjunctiva reactions (redness and chemosis) were observed, which were totally reversible within 8 days. Based on these results, the test item does not need to be classified according to the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008, under the conditions of this study.
- Endpoint:
- eye irritation: in vivo
- 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 source
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 1.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Mean of animals 1, 2 and 3 / Individual scores not specified in the report
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for classification or non-classification
No skin irritation effect were observed for both the analogue substance "Sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate" (CAS 94441 -92 -6) and for Methanol.
Slight eye irritation and mild to moderate eye irritation were observed for the analogue substance "Sodium 3 -[(2 -carboxyethyl)(2 -ethylhexyl)amino]propanoate" (CAS 94441 -92 -6) and Methanol, respectively. These findings are not suffisient to trigger a classification.
However, families of Propionate and Surfactants substances with similar structure are known to induce moderate to severe skin and eye irritation (see the report "Final Amended Safety Assessment - Lauriminodipropionic Acid, Sodium Lauriminodipropionate, and Disodium Lauriminodipropionate as Used in Cosmetics - January 5, 2012" from CIR.
By category approach and as a precaution, the substance "2 -Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide" (water and Methanol free) is considered irritating for skin and causing seriuous eye damage, and classified skin irritating category 2, H315 and eye corrosion category 1, H318.
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.
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