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EC number: 306-227-4 | CAS number: 96690-34-5
- 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:
- 25 Jul - 07 Sep 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- EC Number:
- 306-227-4
- EC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- Cas Number:
- 96690-34-5
- Molecular formula:
- C4H11O4P to C8H20O7P2 as representative molecular formula of the composition as specified in section 1.2
- IUPAC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl: HA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 5 weeks
- Weight at study initiation: 355 - 420 g
- Housing: animals were kept in groups in Terluran-cages on Altromin saw fibre bedding (lot no. 300312).
- Diet: autoclaved hey and Altromin 3122 maintenance diet for guinea pigs (rich in crude fibre, lot no. 1725), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1.5%
- Day(s)/duration:
- single injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 50%
- Day(s)/duration:
- 2
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 3%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 (controls), 10 (test groups)
- Details on study design:
- RANGE FINDING TESTS: a preliminary test with 7 animals was performed to determine appropriate treatment concentrations for the main assay. Cutaneous reactions (erythema and edema) were evaluated 24, 48 and 72 h after injection or topical application with the test substance.
By intradermal route:
- 1 animal: intradermal administrations of the test substance emulsified in physiological saline at concentrations of 2.5 and 5%
- 1 animal: intradermal administrations of the test substance emulsified in physiological saline at concentrations of 1 and 1.5%
By cutaneous route;
- 1 animal: topical treatment with the test substance dissolved in vaseline at concentrations of 50 and 100% for 24 h
- 1 animal: topical treatment with the test substance dissolved in vaseline at concentrations of 50 and 100% for 48 h
- 1 animal: topical treatment with the test substance dissolved in vaseline at concentrations of 12.5 and 25% for 24 h
- 1 animal: topical treatment with the test substance dissolved in vaseline at concentrations of 12.5 and 6% for 48 h
- 1 animal: topical treatment with the test substance dissolved in vaseline at concentrations of 3 and 6% for 24 h
Scored erythema and edema are listed in Table 1 under “Any information on materials and methods incl. tables”.
Based on the results (mild-to-moderate skin irritation, but well tolerated systemically), the following concentrations were chosen for the main assay:
- intradermal induction: 1.5%; epicutaneous induction: 6%; challenge application: 3%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: test substance in physiological saline 0.9% NaCl
Injection 3: test substance in a 1:1 mixture (v/v) FCA/ physiological saline 0.9% NaCl
Epicutaneous: test substance in vaseline
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% vaseline
Injection 3: 50% (v/v) formulation of vaseline in a 1:1 mixture (v/v) FCA/ physiological saline 0.9% NaCl
Epicutaneous: vaseline
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: twice (Day 0 and Day 7)
- Duration: 0-7
- Concentrations: intradermal 1.5%, epicutaneous 6%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance and vaseline only
- Control group: test substance and vaseline only
- Site: left flank (test substance) and right flank (vehicle = intraspecific control)
- Concentrations: 3%
- Evaluation (hr after challenge):24 and 48 h after patch removal
OTHER:
On Day 6 (approx. 24 h before epicutaneous application of the test substance), the test area of the animals was clipped and they were treated with 0.5 g of 10% sodium lauryl sulphate in vaseline in order to induce local irritation. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole (2 and 15% (w/w))
Results and discussion
- Positive control results:
- The sensitivity and reliability of the experimental technique was routinely checked using the positive control substance mercaptobenzothiazole. Ten animals were intradermally (2%) and epicutaneously (25%) induced with the positive control substance, followed by challenge treatment at 15% concentration. The sensitisation rate after challenge application of the positive control substance was 100%, thus fulfilling the criteria for a positive result (≥ 30%) and verifying the sensitivity and reliability of the assay.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 3%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 1.5 and 6%; challenge: 3%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1/10: erythema grade 1
- Remarks on result:
- other: slight evidence of sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 2 and 25%; challenge: 15%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 3/10: erythema grade 1; 5/10: erythema grade 2; 2/10: erythema grade 3; 1/10: edema grade 1; 1/10: edema grade 2
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 3%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 1.5 and 6%; challenge: 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 2 and 25%; challenge: 15%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 2/10: erythema grade 1; 5/10: erythema 2; 3/10: erythema grade 3; 1/10: edema grade 1; 1/10: edema grade 2
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
For the test item, at the first reading time point following challenge, i.e., 24 h, 1/10 animals showed skin reaction described as skin erythema graded 1. In the study report, the finding was described as slight sensitisation. At the second reading time point, i.e., 48 h, none of the 10 animals showed any skin reaction. Thus, under the test conditions used, no obvious skin sensitizing potential could be evidenced with respect to the test item. The suitability of the test system as well as the reliability of the method both were confirmed by the results of the positive control.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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