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Diss Factsheets
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EC number: 944-290-5 | CAS number: -
- 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:
- 2014-07-16 to 2014-10-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- FREY-TOX GmbH, Osteroda 38, 04916 Herzberg/Elster, Germany
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The substance is surface active.
Test material
- Reference substance name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- EC Number:
- 944-290-5
- Molecular formula:
- C38H80NO4PS2 (idealized)
- IUPAC Name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- Test material form:
- liquid: viscous
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: Harlan Laboratories GmbH, NL-5800 AN Venry
- Weight at study initiation: 318-393 g
- Housing: 2-3 animals per cage, macrolon cages (2280 cm2), cleaning and change of bedding 3 times per week
- Diet: ad libitum (Altromin 3123, from Altromin D-32791 Lage, Lippe)
- Water: ad libitum, vitamin C enriched domestic quality water (pH 2.5)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5 % (w/w)
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1000 % (w/w)
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50 % (w/w)
- No. of animals per dose:
- Control group: 5
Test group: 10 - Details on study design:
- RANGE FINDING TESTS:
On request of the sponsor, the skin irritating effect of the test item in the vehicle paraffin subliqu. was examined initially in four instead of two animals during a dermal preliminary investigation in order to find out the minimal irritating concentration for the dermal induction and the maximum non-irritating concentration of the test item for the challenge application.
Animals for the dermal preliminary investigation were initially pre-treated with adjuvant (FCA) by injecting the adjuvant four times intradermal in the scapular area of each animal. Three weeks after the pre-treatment with the adjuvant, a 24-hour occlusive application of four concentrations of the test item on the flanks of the four pre-treated animals took place during the dermal preliminary investigation. Appearing skin reactions were assessed after 24 hrs and 48 hrs.
On the basis of the results of the preliminary investigations the following concentration levels in the vehicle paraffin subliqu. were chosen according to the agreement with the sponsor:
- intradermal induction with 5 % (w/w) test item
- dermal induction with 100 % (w/w) test item
- challenge treatment the 50 % (w/w) test item
MAIN STUDY
A. INDUCTION EXPOSURE Intradermal
- No. of exposures: 3 simultaneous injections (dose volume 0.1 mL)
- Test groups:
Injection (1) - 1:1-mixture (v/v) of FCA and NaCI 0.9 %
Injection (2) - 5 % (w/w) test item in the vehicle paraffin subliqu.
Injection (3) - 5 % (w/w) test item in a 1:1-mixture (v/v) of FCA and NaCI 0.9 %
- Control group:
Injection (1) - 1:1-mixture (v/v) of FCA and NaCI 0.9 %
Injection (2) - vehicle paraffin subliqu.
Injection (3) - 50 % (w/v) preparation of the vehicle paraffin subliqu. in a 1:1-mixture (v/v) of FCA and NaCI 0.9 %
- Site: The first two pairs of injections were given close to each other towards the cranial part of the test area, whereas the third pair of injections was given towards the caudal part of the test area.
- Frequency of applications: 1
- Observation period: 6 days
A. INDUCTION EXPOSURE epicutaneous
- No. of exposures: 1 occlusive patch
- Exposure period: occlusive patch for 48 h
- Test groups: 0.5 mL of 100 % test substance on patch
- Control group: 0.5 mL paraffin subliqu on patch
- Site: area of dorsal skin (approx. 4 x 6 cm) in the scapular region
- Frequency of applications: 1
- Observation period: from day 7 to day 20
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 21
- Exposure period: 24 h
- Test groups: Patch 1: 0.5 mL of 50 % (w/w) test substance; Patch 2: 0.5 mL of the vehicle paraffin subliqu
- Control group: Patch 1: 0.5 mL of 50 % (w/w) test substance; Patch 2: 0.5 mL of the vehicle paraffin subliqu
- Site: Patch 1: right posterior flank of all animals; Patch 2: left posterior flank of all animals
- Evaluation: 24 and 48 h after removal of test substance - Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde (historical control)
Study design: in vivo (LLNA)
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The sensitization potential of the positive reference item has been shown sufficiently by the response of 10 of 10 guinea pigs (100 %) of the test group with positive skin reactions (erythema grade 1 to 3).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% (challenge concentration)
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (challenge concentration)
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema (3), moderate and confluent erythema (1)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
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