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EC number: 619-409-6 | CAS number: 99208-50-1
- 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
Endpoint summary
Administrative data
Description of key information
One Acute toxicity study is available, via the oral route.
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:
- 19 June 2019- 11 July 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Required by REACH
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- relative humidity in the animal room was between 38-83% instead of 45-65% and the temperature was between 20-26°C instead of 20-24°C for several hours due to insufficient capacity of the air conditioning system during a summer heat wave
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- EEC Methods for the determination of toxicity and other health effects. Commission Regulation No. 440/2008, Part B, Method B.1 bis. Acute Oral Toxicity: Fixed Dose Procedure. 30 May 2008
- Deviations:
- yes
- Remarks:
- relative humidity in the animal room was between 38-83% instead of 45-65% and the temperature was between 20-26°C instead of 20-24°C for several hours due to insufficient capacity of the air conditioning system during a summer heat wave
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- Purity: 99.7%
Physical description: white powder
Storage conditions: room temperature
Expiration date: March 20, 2020 - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- The animals were distributed into the test groups at random. If possible, all animals belonging to the same experimental group were kept in one cage. The animals were individually marked by fur clippings. A colour-coded card was prepared for each project, giving details of the test type, project number, treatment start, dose level, sex and number of animals.
Acclimatization: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
Housing: groups of one to five rats (of the same sex and dose group)
Cage Type: Makrolon Type IV, with wire mesh top
Bedding: granulated soft wood bedding
Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum (except for overnight fasting prior to dosing; diet was returned immediately after dosing was complete)
Water: tap water, ad libitum
Environment: temperature 22 + 2°C (except for deviation) relative humidity approx. 45-65% (except for deviation) (with the aim of 50 – 60%) artificial light 6.00 a.m. - 6.00 p.m.
Environmental enrichment: provided throughout the study period (e.g., wooden chew blocks, fun tunnels or suitable nesting material) - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Dose administration was once orally by gavage (feeding needle). The volume administered did not exceed 10 mL/kg b.w.
Based on available information on the toxicity of the test item, 300 mg/kg was chosen as the initial starting dose, since a severe toxicity which may necessitate humane euthanasia was not expected at this dose level.
Two single animals were treated as follows:
Dose level (mg/kg) 300, 2000
Concentration (mg/mL) 30, 200 respectively
Dose volume (mL/kg) 10, 10 respectively
Number of rats Female 1, 1 respectively
In the absence of mortality or toxicity at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:
Dose level (mg/kg) 2000
Concentration (mg/mL) 200
Dose volume (mL/kg) 10
Number of rats Female 4
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study. - Doses:
- 300 mg/kg
2000 mg/kg - No. of animals per sex per dose:
- 300 mg/kg - one rat
2000 mg/kg- five rats - Control animals:
- no
- Details on study design:
- Morbidity/Mortality Inspection and Clinical Observations:
Clinical observations and inspections for morbidity / mortality were performed at least three times within the first six hours after application (i.e., 30 minutes and 1 hour, 2 hours and 4 hours after dosing), thereafter at least once daily for 14 days. All animals were observed for 14 days after dosing.
The nature and severity, where appropriate, of the clinical signs and the time were recorded at each observation for all individual animals. If applicable, the time of death/humane kill was recorded as precisely as possible.
Observations included changes in the skin and fur, eyes and mucous membranes, and respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behavior pattern. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.
Fate of the Animals:
Animals were sacrificed by carbon dioxide asphyxiation followed by cervical dislocation.
Determination of Body Weight:
Body weights were recorded on Day 0 (prior to dosing), Day 7, and 14, or (if applicable) at death (unscheduled).
Necropsy:
A gross necropsy was performed on all animals that died or were humanely killed during the study (if applicable) and at the end of the in-life part. Any macroscopic abnormalities were recorded. Routinely no organs or tissues were retained. - Statistics:
- Data Evaluation:
The test item is classified according to Annex 3 of the OECD Guidelines for Testing of Chemicals No. 420 ‘Acute Oral Toxicity – Fixed Dose Procedure’ (adopted 17 December 2001) as shown in the Flow Chart in Annex 2.
Evaluation of data includes the identification of the number of animals that died during the study (or that were killed for humane reasons), and determination of the nature, severity, onset and duration of the toxic effects. If possible, the signs of toxic effects of evident toxicity are described. Evident toxicity refers to the toxic effects of sufficient severity that administration of the next higher dose level could result in development of severe signs of toxicity and probable mortality. Effects on body weights and abnormalities noted at necropsy were identified.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made. - Preliminary study:
- Dose Level – 300 mg/kg b.w.
There were no deaths during the study.
Clinical signs observed were closed eyes. These signs were only noted on day 1 after dosing. Recovery of the animal, as judged by external appearance and behavior, was complete by day 2.
The animal showed expected gains in body weight over the observation period.
No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 14. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 99.7
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 14.
- Other findings:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of DOPO-HQ was demonstrated to be greater than 2000 mg/kg body weight.
DOPO-HQ is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS), as described in Annex 2. - Executive summary:
The study was performed to assess the acute oral toxicity of DOPO-HQ to the rat.
Methods
Following a sighting test at dose levels of 300 mg/kg b.w. and 2000 mg/kg b.w. in one female rat per dose group, a further group of four fasted females was given a single oral dose of DOPO-HQ, as a suspension in 1% CMC (carboxy methyl cellualose), at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored in all animals during the study. All animals were subjected to gross necropsy.
Results
Mortality: There were no deaths.
Clinical Observations: Closed eyes were noted on day 1 after application only in the animal treated at a dose level of 300 mg/kg. There were no signs of systemic toxicity noted in the remaining animals.
Body Weight: All animals showed expected gains in body weight.
Necropsy: No abnormalities were noted at necropsy.
Conclusion
The acute median lethal oral dose (LD50) to rats of DOPO-HQ was demonstrated to be greater than 2000 mg/kg body weight.
DOPO-HQ is included in Category 5/Unclassified according to the Globally Harmonised System (GHS), as described in Annex 2.
Reference
Additional information
Justification for classification or non-classification
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.
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