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EC number: 602-997-3 | CAS number: 124495-18-7
- 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
Toxicity to birds
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to birds: acute oral toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-1 (Avian Acute Oral Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Substance ID: TSN 100010
- Name of substance: XDE-795
- Purity: 99% - Dose method:
- gavage
- Analytical monitoring:
- no
- Vehicle:
- yes
- Remarks:
- corn oil
- Test organisms (species):
- Colinus virginianus
- Limit test:
- no
- Remarks:
- Single dose
- Post exposure observation period:
- 14 days
- No. of animals per sex per dose and/or stage:
- 5
- Control animals:
- yes
- Nominal and measured doses / concentrations:
- Nominal concentrations: 292, 486, 810, 1350, and 2250 mg a.i./kg bw
- Reference substance (positive control):
- no
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 2 250 mg/kg bw
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- mortality
- Remarks on result:
- other: highest dose tested
- Dose descriptor:
- NOEL
- Effect level:
- < 292 mg/kg bw
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- other: body weight and feed consumption
- Validity criteria fulfilled:
- yes
- Conclusions:
- LD50 (Northern bobwhite): >2250 mg/kg bw (highest dose tested)
NOEL (Northern bobwhite): <292 mg/kg bw (body weight and feed consumption) - Executive summary:
The study was conducted to evaluate the acute toxicity of the test substance administered to the Northern bobwhite as a single oral dose. The study was conducted following EPA OPP 71-1.
Bobwhite were dosed at nominal concentrations of 292, 486, 810, 1350, and 2250 mg a.i./kg bw. Treatment and control birds were observed for 14 days after dosing.
There were no treatment related mortalities or overt signs of toxicity at any of the dosages tested. When compared to the controls, there was a dose responsive loss in body weight or reduction in body weight gain among all birds at all dosage levels during days 0-3. A continued loss in body weight was noted among all birds at 2250 mg a.i./kg during days 4-7. A reduction in feed consumption was seen for males at 292 and 486 mg a.i./kg and among all birds at 810, 1350 and 2250 mg a.i./kg during days 4-7.
In conclusion, the acute oral LD50 value for northern bobwhite exposed to the test substance was determined to be greater than 2250 mg a.i./kg, the highest dosage tested. The no mortality level was 2250 mg a.i./kg. The no observed effect level was lower than 292 mg a.i./kg, based on the reduction in body weight and feed consumption noted among birds at 292 mg a.i./kg.
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 206 (Avian Reproduction Test)
- Deviations:
- yes
- Remarks:
- The temperature within the incubator during the incubation phase should be 37 to 38°C (99.0 to 99.5°F). The minimum temperature in the incubator housing the chicks was noted to be 80°F. This did not effect the quality and integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-4 (Avian Reproduction Test)
- Deviations:
- yes
- Remarks:
- The temperature within the incubator during the incubation phase should be 37 to 38°C (99.0 to 99.5°F). The minimum temperature in the incubator housing the chicks was noted to be 80°F. This did not effect the quality and integrity of the study.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Lot number: DECO-97-152-1
- Purity: 97.4% - Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- yes
- Remarks:
- diet
- Test organisms (species):
- Colinus virginianus
- Limit test:
- no
- Remarks:
- F0 generation test period: 23 weeks; F1 generation growth period: 13 weeks
- No. of animals per sex per dose and/or stage:
- 16
- Control animals:
- yes, plain diet
- Nominal and measured doses / concentrations:
- Nominal concentrations: 250, 500, 1000 ppm a.i.
- Reference substance (positive control):
- no
- Key result
- Duration (if not single dose):
- 23 wk
- Dose descriptor:
- other: NOAEL
- Effect level:
- 1 000 other: ppm
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- other: parental systemic toxicity, reproduction and F1 generation
- Remarks on result:
- other: highest concentration tested
- Validity criteria fulfilled:
- yes
- Conclusions:
- NOAEL (Bobwhite quail): 1000 ppm a.i., highest concentration tested (parental systemic toxicity, reproduction and F1 generation)
- Executive summary:
The dietary reproductive toxicity study was conducted to determine the effects of the test substance on young adult male and female Bobwhite quail in their first breeding season. The study was conducted following OECD guideline 206 and EPA OPP 71-4.
Dietary levels of 0, 250, 500, and 1000 ppm a.i. were chosen and the Bobwhite quail received their respective test diets for 161 days.
The ingestion of the test substance by the parental generation at levels of 250, 500, or 1000 ppm a.i. produced no statistically significant effects (p >0.05) on body weights, feed consumption, and reproductive success of the F0 generation, or on body weights, feed consumption, and survivability of the F1 generation.
Based on the lack of treatment-related effects on parental systemic toxicity, reproduction, and for the F1 generation, the No-Observed-Adverse-Effect Level (NOAEL) was 1000 ppm a.i.
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 206 (Avian Reproduction Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-4 (Avian Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Lot number: DECO-97-152-1
- Purity: 97.4% - Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- yes
- Remarks:
- diet
- Test organisms (species):
- Anas platyrhynchos
- Limit test:
- no
- Remarks:
- F0 generation test period: 21 weeks; F1 generation growth period: 12 weeks
- No. of animals per sex per dose and/or stage:
- 16
- Control animals:
- yes, plain diet
- Nominal and measured doses / concentrations:
- Nominal concentrations: 250, 500, 1000 ppm a.i.
- Reference substance (positive control):
- no
- Key result
- Duration (if not single dose):
- 21 wk
- Dose descriptor:
- other: NOAEL
- Effect level:
- 1 000 other: ppm
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- signs of toxicity
- Remarks on result:
- other: highest concentration tested
- Key result
- Duration (if not single dose):
- 21 wk
- Dose descriptor:
- other: NOAEL
- Effect level:
- 500 other: ppm
- Conc. / dose based on:
- act. ingr.
- Remarks:
- 47.7 mg a.s./kg bw/day
- Basis for effect:
- other: reproductive success and F1 generation
- Validity criteria fulfilled:
- yes
- Conclusions:
- NOAEL (Mallard duck): 1000 ppm a.i. (parental systemic toxicity) (highest concentration tested)
NOAEL (Mallard duck): 500 ppm a.i. (reproductive success and F1 generation) - Executive summary:
The dietary reproductive toxicity study was conducted to determine the effects of the test substance on young adult male and female mallard ducks in their first breeding season. The study was conducted following OECD guideline 206 and EPA OPP 71-4.
Dietary levels of 0, 250, 500, and 1000 ppm a.i. were chosen and the Mallard ducks received their respective test diets for 147 days.
The ingestion of the test substance by the parental generation at levels of 250 or 500 ppm a.i. produced no biologically significant effects (P >0.05) on adult body weights, adult feed consumption, reproductive success of the F0 generation, hatchling body weights, hatchling feed consumption, and survivability of the F1 generation. Similarly, the ingestion of the test substance by the parental generation at a level of 1000 ppm a.i. produced no biologically significant effects on any of the aforementioned parameters, except for reproductive success of the F0 generation and survivability of the F1 generation. Treatment-related adverse effects were noted for these variables.
The No-Observed-Adverse-Effect Level for this study was determined to be 1000 ppm a.i. for the parental generation and 500 ppm a.i. for reproductive success and for the F1 generation.
Referenceopen allclose all
Description of key information
21-week NOAEL (Mallard duck): 1000 ppm a.i. (highest concentration tested, parental) and systemic 500 ppm a.i. (reproductive success and F1 generation); OECD 206; Reliability = 1
23-week NOAEL (Bobwhite quail): 1000 ppm (highest dose tested); OECD 206; Reliability = 1
Oral LD50 (Northern bobwhite): >2250 mg/kg bw (highest dose tested); EPA OPP 71-1; Reliability = 1
Key value for chemical safety assessment
- Short-term EC50 or LC50 for birds:
- 2 250 mg/kg food
Additional information
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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