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EC number: 936-023-6 | CAS number: 950782-86-2
- 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:
- OECD Guideline 223 (Avian Acute Oral Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA 71-1
- GLP compliance:
- yes (incl. QA statement)
- Dose method:
- capsule
- Analytical monitoring:
- yes
- Test organisms (species):
- Colinus virginianus
- Details on test organisms:
- TEST ORGANISM
- Common name: Bobwhite quail
- Source: WW Quail Ranch of Oklahoma, located in Wardville, Oklahoma
- Age at test initiation: 16 weeks
- Sexes used: males and females - Limit test:
- no
- Total exposure duration (if not single dose):
- 14 d
- Remarks:
- Single dosing with 14-day post-dose monitoring period
- Post exposure observation period:
- 14 days
- No. of animals per sex per dose and/or stage:
- Ten birds (5 males and 5 females) were randomly allocated to each of the four treatment levels (500, 1000, and 2000 mg ai/kg bw) and one control (non-exposed) group
- Control animals:
- yes
- Duration (if not single dose):
- 14 d
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- body weight
- Remarks:
- , Feed consumption, mortalities, Post-Mortem Examinations
- Remarks on result:
- other: Single dosing with 14-day post-dose monitoring period
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 206 (Avian Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.2300 (Avian Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA Guideline 71-4
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Draft Guideline (April 2000)
- Principles of method if other than guideline:
- Two separate studies were conducted and combined into one report. The mallard
reproduction study exposed adult mallard ducks (Anas platyrhynchos) to AE 1170437
technical for approximately 22 weeks and the mallard modified reproduction study exposed adult mallard ducks (Anas platyrhynchos)
to AE 1170437 technical for approximately 6 weeks. - GLP compliance:
- yes (incl. QA statement)
- Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- no
- Test organisms (species):
- Anas platyrhynchos
- Details on test organisms:
- TEST ORGANISM
- Common name: mallard ducks
- Source: Whistling Wings, Hanover, Illinois
- Age at test initiation: 16 weeks
- Disease free: yes - Limit test:
- no
- Total exposure duration (if not single dose):
- 22 wk
- Remarks:
- second study with 6 weeks of exposure
- No. of animals per sex per dose and/or stage:
- 70 males and 70 females
- Control animals:
- yes
- Duration (if not single dose):
- 22 wk
- Dose descriptor:
- other: NOAEC
- Effect level:
- >= 1 015 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- reproductive parameters
- Remarks:
- and mortality
- Duration (if not single dose):
- 22 wk
- Dose descriptor:
- other: NOAEC
- Effect level:
- >= 114 mg/kg bw/day
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- reproductive parameters
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 206 (Avian Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.2300 (Avian Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA Guideline 71-4
- GLP compliance:
- yes (incl. QA statement)
- Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- no
- Test organisms (species):
- Colinus virginianus
- Details on test organisms:
- TEST ORGANISM
- Common name: northern bobwhite quail
- Source: WW Quail Ranch of Oklahoma, Wardville, Oklahoma
- Age at test initiation: approximately 16 weeks
- Disease free: yes
- Kept according to standard practices: yes - Limit test:
- no
- Total exposure duration (if not single dose):
- 23 wk
- No. of animals per sex per dose and/or stage:
- Seventy two pairs (i.e. one male & one female) were utilized for the study.
- Control animals:
- yes
- Duration (if not single dose):
- 23 wk
- Dose descriptor:
- NOEC
- Effect level:
- >= 1 023 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- reproductive parameters
- Remarks:
- and mortality
- Duration (if not single dose):
- 23 wk
- Dose descriptor:
- NOEC
- Effect level:
- >= 111 mg/kg bw/day
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- reproductive parameters
- Remarks:
- and mortality
- 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:
- OECD Guideline 223 (Avian Acute Oral Toxicity Test)
- GLP compliance:
- yes (incl. QA statement)
- Dose method:
- gavage
- Vehicle:
- yes
- Details on preparation and analysis of diet:
- DIET PREPARATION
- Preparation of doses: The test substance was dispersed in corn oil. The dosage was adjusted to 100% active ingredient. Therefore, the test dosages and the LD50 value are reported as milligrams of active ingredient per kilogram of body weight. Nominal dosages used in this study were 0, and 2000 milligrams of active ingredient per kilogram of body weight (mg a.i./kg). - Test organisms (species):
- Poephila guttata
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra finches
- Source: The birds were obtained from Maryland Exotic Birds Pasadena, MD
- Age at test initiation (mean and range, SD):
- Sexes used: males and femals
- Disease free: yes
- Kept according to standard practices: yes - Limit test:
- yes
- Total exposure duration (if not single dose):
- 14 d
- Remarks:
- day of dosing (Day 0)
- Post exposure observation period:
- Post-dosing Observation – 14 days
- No. of animals per sex per dose and/or stage:
- 5 males and five females
- Control animals:
- yes
- Duration (if not single dose):
- 14 d
- Dose descriptor:
- LC50
- Effect level:
- > 2 000 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- mortality
- Endpoint:
- short-term toxicity to birds: dietary 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:
- OECD Guideline 205 (Avian Dietary Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.2200 (Avian Dietary Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA Guideline 71-2
- GLP compliance:
- yes (incl. QA statement)
- Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- no
- Test organisms (species):
- Colinus virginianus
- Limit test:
- no
- Total exposure duration (if not single dose):
- 5 d
- Post exposure observation period:
- The exposure period was followed by a 3-day subsequent recovery phase on untreated feed.
- Control animals:
- yes
- Nominal and measured doses / concentrations:
- Measured dietary concentrations of 324, 572, 1234, 2545, and 5007 mg ai/kg feed. were used.
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- NOEC
- Effect level:
- 5 007 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- signs of toxicity
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- LC50
- Effect level:
- > 5 007 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- mortality
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- LC50
- Effect level:
- > 787 mg/kg bw
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- mortality
- Endpoint:
- short-term toxicity to birds: dietary 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:
- OECD Guideline 205 (Avian Dietary Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.2200 (Avian Dietary Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA Guideline 71-2
- GLP compliance:
- yes (incl. QA statement)
- Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- no
- Test organisms (species):
- Anas platyrhynchos
- Limit test:
- no
- Total exposure duration (if not single dose):
- 5 d
- Post exposure observation period:
- The exposure period was followed by a 3-day subsequent recovery phase on untreated feed.
- Control animals:
- yes
- Nominal and measured doses / concentrations:
- Measured dietary concentrations of 0 (control), 329, 647, 1320, 2518, and 5215 mg ai/kg feed were used.
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- NOEC
- Effect level:
- 2 518 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- signs of toxicity
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- LC50
- Effect level:
- > 5 215 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- mortality
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- LC50
- Effect level:
- > 1 126 mg/kg bw
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- mortality
Referenceopen allclose all
Acute Oral Toxicity to Birds.
Acute Oral LD50WithNorthern BobwhiteQuail Exposed to AE 1170437 Technical |
|
|
mg ai/kg body weight |
LD50= |
>2000 |
Lowest lethal dose (LLD) = |
>2000 |
Lowest observed adverse effect level (LOAEL) = |
>2000 |
No observed adverse effect level (NOAEL) = |
2000 |
Observations:
No clinical signs of toxicity or treatment-related mortalities were noted at any treatment level. There were no statistically significant reductions in body weight or growth at any treatment level. There was no treatment related reduction in feed consumption at any treatment level. Post-mortem examinations revealed no treatment related gross lesions or unusual observations.
Conclusion:
Based on the results of this study, the LD50 for technical AE 1170437 in northern bobwhite quail was >2000 mg ai/kg bw. Based on all parameters measured and observed, the NOAEL was 2000 mg ai/kg bw and the LOAEL was >2000 mg ai/kg bw technical AE 1170437.
Results are confirmend in the 6-week modified reproduction study.
Conclusion:
The No Observed Adverse Effect Concentration (NOAEC) for both parental toxicity and
reproduction endpoints of mallard ducks exposed AE 1170437 in a 22-week reproduction
study and 6-week modified reproduction study was 1015 mg ai/kg feed or 114 mg ai/kg
bw/day. The Lowest Observed Adverse Effect Concentration (LOAEC) was >1015 mg ai/kg
food or >114 mg ai/kg bw/day.
Dietary Concentration:
The nominal amounts of AE 1170437 technical in the dietary feed were administered at levels of 0 (control), 250, 500, and 1000 mg/kg feed. The average measured amounts of AE 1170437 technical for Week’s 1, 5, 10, 15, and 20 were determined as 0, 252, 524, and 1023 mg ai/kg feed representing percent nominal values of 101%, 105%, and 102%, respectively. These values correspond to daily dietary dose levels of 0, 26, 54, and 111 mg ai/kg bw/day, respectively. A summary of the dietary concentrations are included in the following table.
Feed Analysis Summary of AE 1170437 |
||||
Nominal Dietary Level |
Measured Dietary Level |
Percent of |
Daily Dietary Dose |
|
(mg ai/kg feed) |
(mg ai/kg feed) |
Nominal |
(mg ai/kg bw/day) |
|
0 (control) |
0 |
- |
- |
|
250 |
252 |
101 % |
26 |
|
500 |
524 |
105 % |
54 |
|
1000 |
1023 |
102 % |
111 |
|
Adult Quail Clinical observations of adult birds exhibited no treatment related signs of toxicity. Adult mortality for the study included one control female bird with no mortality occurring in the treatment birds. There were no treatment–related mortalities, overt signs of toxicity or treatment-related effects upon body weight or feed consumption with the exception of feather loss and minor injuries as a result of cage wear. There were no compound related symptoms of toxicity in the adults and offspring.
Reproductive Effects
There were no statistically significant adverse effects for any reproductive endpoint in the study. The table below presents the reproductive endpoints totals.
Reproductive Parameter |
Nominal Dietary Concentration (mg ai/kgfeed) |
|||
Control |
250 |
500 |
1000 |
|
No. of Eggs Laid |
862 |
1099 |
1021 |
1043 |
No. of Eggs Cracked |
13 |
23 |
14 |
16 |
No. of Eggs Set |
786 |
988 |
923 |
932 |
No. of Viable Embryos |
751 |
953 |
877 |
891 |
No. of 3-Week Live Embryos |
750 |
941 |
872 |
885 |
No. of Hatched |
708 |
865 |
836 |
834 |
No. of 14-Day Survivors |
703 |
859 |
826 |
827 |
The acute oral LD50 value for Zebra Finch exposed to BCS-AA10717 Technical as a single oral dose was determined to be greater than 2000 mg a.i./kg, the highest dosage tested. The no-treatment related mortality level was 2000 mg a.i./kg.
Short-term dietary toxicity to birds
Subacute Dietary LC50 WithNorthern BobwhiteQuail Exposed to AE 1170437 Technical |
||
|
mg ai/kg feed |
mg ai/kg bodyweight |
LC50= |
>5007 |
>787 |
Lowest lethal concentration (LLC) = |
>5007 |
>787 |
Lowest observed effect concentration (LOEC) = |
>5007 |
>787 |
No Observed Effect Concentration (NOEC) = |
5007 |
787 |
Observations:
No clinical signs of toxicity or treatment-related mortalities were noted at any treatment level. There were no statistically significant reductions in body weight or growth during the exposure period at any treatment level. There was no treatment related reduction in feed consumption at any treatment level. Postmortem examinations revealed no treatment related gross lesions or unusual observations.
Conclusion:
The sub-acute dietary LC50 of technical AE 1170437 in Northern Bobwhite was >5007 mg ai/kg feed or >787 mg ai/kg bodyweight. Based on all parameters measured, the NOEC was 5007 mg ai/kg feed (787 mg ai/kg bodyweight) and the LOEC was >5007 mg ai/kg feed (>787 mg ai/kg bodyweight).
Conclusion: The sub-acute dietary LC50 of technical AE 1170437 in Mallards was >5215 mg ai/kg feed or >1126 mg ai/kg bodyweight. Based on all parameters measured, the NOEC was 2518 mg ai/kg feed (577 mg ai/kg bodyweight) and the LOEC was 5215 mg ai/kg feed (1126 mg ai/kg bodyweight).
Sub-acute Dietary LC50 With Mallards Exposed to AE 1170437 technical |
||
|
mg ai/kg feed |
mg ai/kg bodyweight |
LC50= |
>5215 |
>1126 |
Lowest lethal concentration (LLC) = |
>5215 |
>1126 |
Lowest observed effect concentration (LOEC) = |
5215 |
1126 |
No Observed Effect Concentration (NOEC) = |
2518 |
577 |
Description of key information
No biologically effects could be observed in birds up to the highest test concentration of the test substance. Therefore, based on the available information, there is no indication for bioaccumulation of the substance or secondary poisoning.
Key value for chemical safety assessment
Additional information
After single oral application LD50 values of >2000 mg /kg diet were obtained in studies with northern bobwhite quails and zebra finch. Neither mortality nor clinical signs of toxicity occurred in any study. Short-term (5 -day) feeding resulted in LC50 values of > 5000 ppm (diet) in the northern bobwhite quail and the mallard duck. Neither mortality nor clinical signs of intoxication attributable to the test substance were observed in any study. In two reproduction studies, one with northern bobwhite quail and the other with mallard ducks, the NOAEL for systemic and reproductive toxicity was considered to be > 1000 ppm (diet), which is the limit dose according to the OECD testing guideline. The substance showed a very low acute, short- and long-term hazard potential to birds as evidenced by endpoint data being above or equal the limit doses as specified in the corresponding testing guidelines. All studies referred to herein have been conducted according to the prevailing OECD or US EPA testing guidelines and GLP.
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.