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EC number: 291-909-3 | CAS number: 90506-47-1
- 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:
- 2015
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Remarks:
- A relative humidity higher than 70% was registered on 02, 04 & 07 July 2015. The minimum value measured was 73%. This deviation is considered as without impact on the conclusion of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine
- EC Number:
- 291-909-3
- EC Name:
- Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine
- Cas Number:
- 90506-47-1
- Molecular formula:
- complex substance
- IUPAC Name:
- Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Arcot 3135 from PCAS, Batch N°80555C079
- Production date: May 2015
- Date received: 12 June 2015
- Expiration date of the batch: May 2016
- Purity test date: 28 May 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: supplied by Elevage JANVIER LABS (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks old.
- Weight at study initiation:
- Fasting period before study:
- Housing: Solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet & water: ad libitum. Drinking water (tap-water from public distribution system) and foodstuff (A04, SAFE) were supplied freely. Food was removed on D-1 and then redistributed 4 hours after the test item administration.
- Acclimation period: at least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C) & Humidity (%): The temperature and relative humidity of the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively.
- Air changes (per hr): The rate of air exchange was at least ten changes per hour.
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
No vehicle used
MAXIMUM DOSE VOLUME APPLIED: one dose of 2000 mg/kg body weight was applied
The test item was administered by gavage under a volume of 2.22 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula.
CLASS METHOD
- Rationale for the selection of the starting dose: cut off value for classification firstly tested. - Doses:
- One dose of 2000 mg/kg body weight was applied
- No. of animals per sex per dose:
- 3 (two step study, leading to a total of 6 animals)
- Control animals:
- yes
- Remarks:
- 3 animals received the control item distilled water, administered by gavage under a volume of 10mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day DO (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: no
- Other examinations performed: Body weight, Spontaneous activity, Preyer's reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lachrymation, Righting reflex, Back hair appearance.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No clinical signs related to the administration of the test item were observed during the study.
- Body weight:
- The body weight evolution of the animals remained normal during the study.
- Other findings:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item ARCOT 3135 is higher than 2000 mg/kg body weight by oral route in the rat.
The test item ARCOT 3135 does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required. - Executive summary:
The test item ARCOT 3135 was administered to a group of 6 females Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No.423 dated December 17th, 2001 and the test method B. I tris of the Council regulation No. 440/2008.
No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
In conclusion, the LD50 of the test item ARCOT 3135 is higher than 2000 mg/kg body weight by oral route in the rat.
The test item ARCOT 3135 does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.
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