Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Aug - 19 Sep 2013
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 8 Feb 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.1000 (Acute toxicity testing background)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8 - 11 weeks
- Weight at study initiation: 144 - 154 g (animals 1-3; step 1), 170 - 178 g (animals 4-6; step 2), 150 - 165 g (animals 7-9; step 3) and 152 - 160 g (animals 10-12; step 3)
- Fasting period before study: 16 to 19 h (access to water was permitted)
- Housing: animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 030512).
- Diet: Altromin 1324 maintenance diet for rats and mice (lot no. 0939), ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8, 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
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqua ad injectionem (sterile water)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL (2000 mg/kg bw dose groups) and 0.03 g/mL (300 mg/kg bw dose groups)
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: the vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no.: 10952-1
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: For all animals of step 1 and step 2, 1.5 g of the test item were emulsified with the vehicle to gain a final volume of 7.5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. For all animals of step 3 and step 4, 0.3 g of the test item were emulsified with the vehicle to gain a final volume of 10 mL and to achieve a dose of 300 mg/kg body weight at a dose volume of 10 mL/kg body weight. The dose formulations were made shortly before each dosing occasion. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension for 10 min before every dose administration. - Doses:
- Step 1 and 2: 2000 mg/kg bw
Step 3 and 4: 300 mg/kg bw - No. of animals per sex per dose:
- 3 per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on Day 1 (prior to the administration) and on Days 8 and 15. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, animals were observed for clinical signs once daily until the end of the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Step 1 (2000 mg/kg bw): 1/3 females died
Step 2 (2000 mg/kg bw): 3/3 females died
Step 3 and 4 (300 mg/kg bw): 0/3 females died - Clinical signs:
- other: 2000 mg/kg bw: reduced spontaneous activity, moving the bedding, kyphosis, bradykinesia, piloerection, tremor and salivation; in the surviving animals of this dose group, all symptoms recovered within up to 2 days post dose. 300 mg/kg bw: reduced spontane
- Gross pathology:
- Necropsy revealed no substance-related findings in surviving animals. Macroscopic findings of the four animals found dead at 2000 mg/kg bw involved bleeding nose (1/4 dead animals) and a bloated stomach (4/4 dead animals) containing remains of the test item (3/4 dead animals).
Any other information on results incl. tables
Table 1. Clinical signs and mortality - acute oral toxicity
Step |
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death (dead animals/3 animals) |
Mortality (%) |
1 |
2000 |
1/3/3 |
5 min - Day 2 |
2 h 10 min |
33 |
2 |
2000 |
3/3/3 |
10 min - death |
1 h 40 min (1/3) + Day 2 (2/3) |
100 |
3 |
300 |
0/3/3 |
5 min - Day 2 |
--- |
0 |
4 |
300 |
0/3/3 |
10 - 30 min |
--- |
0 |
LD50 cut-off = 500 mg/kg bw |
* first number = number of dead animals, second number = number of animals with clinical signs, third number = number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- CLP: Acute Oral 4, H302
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.