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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 618-780-1 | CAS number: 916809-14-8
- 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
Endpoint summary
Administrative data
Description of key information
LD50(oral) > 2000 mg/kg (BASF, 2008)
LD50(dermal) > 2000 mg/kg (BASF, 2010)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - July 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Baden-Württemberg Umweltministerium
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 8712 / 056
- Purity: > 95 %
- Physical state / color: solid / white
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: < - 18 °C
- Solubility and stability of the test substance in the vehicle: Good homogeneity in olive oil Ph. Eur / DAB. The stability of the test substance in the vehicle was determined indirectly by the concentration control analysis by the sponsor. For this purpose, the samples taken were stored at room temperature over the maximum duration of the administration period and were subsequently deep-frozen and sent to the sponsor for analysis.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For better handling the test substance was ground with a mortar and a pistel. The test substance preparation was produced for each administration group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test substance preparation during application was provided by stirring with a magnetic stirrer.
FORM OF ADMINISTRATION
Emulsion - 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 Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 178 g (group 1) and 187 g (group 2) ± 20 %, respectively
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: The animals were housed in fully air-conditioned rooms.
- Diet (e.g. ad libitum): VRF1 (P), SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 20 - 80 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: good homogeneity in olive oil Ph. Eur / DAB
CLASS METHOD
- Rationale for the selection of the starting dose: By the request of the sponsor a starting dose of 2000 mg/kg body weight has been chosen in the first step with 3 female animals. As none of these animals died, 2000 mg/kg body weight was administered to an additional group of 3 female animals in a second step. Because no mortality occured the study was terminated. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation
- recording of signs and symptoms several times on the day of administration, at least once each work day for the individual animals
- a check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays
- necropsy with gross-pathology examination on the last day of the observation period after killing by CO2-inhalation in a chamber with increasing concentrations over time
- no histological examinations were performed
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,mortality, necropsy, gross-pathology examination - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Clinical observation revealed impaired general state, dyspnea, reduced feces, staggering, salivation, exsiccosis and piloerection. Findings were observed from hour 0 through up to study day 8 after administration.
- Gross pathology:
- No macroscopic abnormalities were noted in the animals examined on the last day of observation.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- no mortality observed
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg body weight in rats.
- Executive summary:
The study was performed to assess the acute toxicity following oral administration of the test substance in Wistar rats.
Single doses of 2000 mg/kg body weight of the test material preparations in olive oil Ph. Eur. / DAB were given to 2 test groups of three fasted female animals each, (2000 mg/kg in 6 females) by gavage in a sequential manner.
No mortality occured.
Clinical observation revealed impaired general state, dyspnea, reduced feces, staggering, salivation, exsiccosis and piloerection. Findings were observed from hour 0 through up to study day 8 after administration.
The mean body weights of the administration groups increased normally throughout the study period.
No macroscopic pathologic abnormalities were noted in the animals on the last day of observation.
Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg body weight in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- (from the competent authority) Umweltministerium Baden-Württemberg
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:Wl (Han) SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks.
- Weight at study initiation: 239 - 283 g (males); 209 - 231 g (females)
- Housing: single housing in Makrolon cages, type III
- Diet (e.g. ad libitum): VRF1 (P); SOS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Remarks:
- Ph. Eur.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 40 cm2
- % coverage: 10%
- Type of wrap if used: semi occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2860 mg/kg b.w. (because the test-substance preparaton in a higher concentration was a paste, the preparation was not applicable in mL. The dosing for each animal has been provided in g by using a scale)
- Concentration (if solution): 70 g/100 mL (paste)
- Paste formed: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no macroscopic pathologic abnormalities noted
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no macroscopic pathologic abnormalities noted
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no macroscopic pathologic abnormalities noted
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination. No local effects were observed.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of LIMUS-Sambaydestillation after dermal application was found to be greater than 2000 mg/kg bw in male and female rats. Based on the results presented in this study, the test substances has not to be classified according to Directive 67/548/EEC and and GHS (UN) criteria.
- Executive summary:
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test substance (as suspension in olive oil Ph. Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.
No mortality occured. Accordingly, the acute dermal median lethal dose (LD50) was determined to be
LD50, dermal, rat > 2000 mg/kg bw
No signs of systemic toxicity or skin effects were observed in the animals.
The mean body weight of the animals increased within the normal range throughout the study period.
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity:
There is no acute oral toxicity study for NPPT available but the following data is suitable for a read across:
The study was performed to assess the acute toxicity following oral administration of the test substance in Wistar rats.
Single doses of 2000 mg/kg body weight of the test material preparations in olive oil Ph. Eur. / DAB were given to 2 test groups of three fasted female animals each, (2000 mg/kg in 6 females) by gavage in a sequential manner.
No mortality occured.
Clinical observation revealed impaired general state, dyspnea, reduced feces, staggering, salivation, exsiccosis and piloerection. Findings were observed from hour 0 through up to study day 8 after administration.
The mean body weights of the administration groups increased normally throughout the study period.
No macroscopic pathologic abnormalities were noted in the animals on the last day of observation.
Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg body weight in rats.
Acute dermal toxicity:
There is no acute dermal toxicity study for NPPT available but the following data is suitable for a read across:
In an acute dermal toxicity study (Limit Test) according to OECD 402 guideline and GLP (BASF, 2010), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of LIMUS Sambaydestillation (as suspension in olive oil Ph.Eur.) to the clipped skin (dorsal and dorso-Iateral parts of the trunk) and covered by semi occlusive dressing for 24 hours.
The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.
No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) in rats was determined to be > 2000 mg/kg bw.
No signs of systemic toxicity or skin effects were observed in the animals.
The mean body weight of the animals increased within the normal range throughout the study period.
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
Read Across justification:
LIMUS-Sambaydestillation is a reaction mass of phosphorothioic triamide, N-butyl- (NBPT) and phosphorothioic triamide, N-propyl- (NPPT), the subject of this registration. The relation of NBPT and NPPT in the reaction mass is ca. 3:1 and the overall total content of NBPT and NPPT in the reaction mass is up to 85 %. Thus, as the reaction mass contains a certain amount of NPPT (up to ca. 21 %) and based on the structural similarities between NBPT and NPPT (NPPT is one CH2 -group shorter) the reaction mass is suitable for a read across and thus for filling the data gaps of NPPT.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classificat ion purposes under Regulation 1272/2008. No mortality occured at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.
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.