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EC number: 616-248-3 | CAS number: 75627-31-5
- 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-August 1978
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No data on batchno. and limited info on composition. Limited reported study according to standard/guideline (max score can be 2).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- observation 24 h after patch removal and not also after 48 h
- Principles of method if other than guideline:
- During the induction phase it has been stated that 0.5 ml test agent was emulsified with 0.05 ml Freund's adjuvant. This should read 0.05 ml test agent plus 0.05 ml Freund's adjuvant.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate
- EC Number:
- 616-248-3
- Cas Number:
- 75627-31-5
- Molecular formula:
- UVCB not applicable
- IUPAC Name:
- disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate
- Details on test material:
- Name of test compound: TL 856
Appearance: clear viscous liquid
Date of receipt: July 1978
Composition:
- mixture of non ionic and amphoteric surfactants (ca. 60% a.s)
- remainder: water and propylene glycol
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: Porcellus Animals Ltd., UK
- Age at study initiation: no info
- Weight at study initiation: 300-400 g
- Housing: 5 to a cage
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: no info
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info
IN-LIFE DATES: no info
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.1 ml test compound 10% (v/v)
Topical induction: 10% v/v on patch
Topical challenge: 10% v/v on patch
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.1 ml test compound 10% (v/v)
Topical induction: 10% v/v on patch
Topical challenge: 10% v/v on patch
- No. of animals per dose:
- 10 in test group
5 in control group - Details on study design:
- RANGE FINDING TESTS: using 2 guinea pigs the following levels were tested for irritation: 2, 5, 10 and 20% v/v. The test compound was moderately irritant at 20%. Therefore 10% v/v was chosen as challenge concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1st intradermal, 2nd topical)
- Exposure period: single injection plus topical application for 48 h (6 days after injection)
- Test groups: test compound
- Control group: Freund's adjuvant only
- Site: 4x6 cm across the scapular region
- Concentrations: 10% v/v (injection), 10% v/v (topical)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 24 h
- Test groups: 10% v/v
- Control group: 10% v/v
- Site: right flank
- Concentrations: 10% v/v
- Evaluation (hr after challenge): 24 h after patch removal
OTHER: - Challenge controls:
- yes
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% v/v at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% v/v at challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- At a non-irritant concentration of 10% v/v in water, the test compound was not a sensitiser.
- Executive summary:
A study was performed to assess the contact sensitisation potential of the test material in the Dunkin-Hartley guinea pig. The study, a Guinea Pig Maximization Test, was essentially performed in compliance with the requirements of OECD 406. Ten test and five control animals were used for the main study. Based on the results of a sighting test using 2 guinea pigs, the concentration of the test compound for the induction and challenge phases were selected as follows: 10% v/v in water. This concentration was not-irritating, the next higher tested concentration of 20% v/v was moderately irritating. No reactions were observed in both test and control group. The test material, TL 856, was therefore considered a non-sensitiser to guinea pig skin.
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