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EC number: 406-250-0 | CAS number: 72619-32-0 HALOXYFOP R-(+)-ME HERBICIDAL CHEMICAL
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.9 (Repeated Dose (28 Days) Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3200 (Repeated Dose Dermal Toxicity -21/28 Days)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
- EC Number:
- 406-250-0
- EC Name:
- Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
- Cas Number:
- 72619-32-0
- Molecular formula:
- C16H13ClF3NO4
- IUPAC Name:
- methyl 2-(4-{[3-chloro-5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Haloxyfop-R-Methyl Ester
Lot # OC30150101 (TSN102229)
Purity: 96.7% R + 1.09% S
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- The rat (Rattus norvegicus) was selected as a test system because it is a readily available laboratory rodent species. It has been historically shown to be a suitable model for repeated dose toxicity studies. The OECD and other regulatory authorities also recommend it. The results of the study are believed to be of value in predicting the toxicity of the test item to man.
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Triplicate samples from each concentration and corn oil (Vehicle) were sent for homogeneity and active ingredient concentration analysis on day 1. The results of A.I. concentration and homogeneity from the samples collected on day 1 (pre-dosing) revealed mean percent recovery of 107, 110 and 108 at the concentrations of 2 (low dose), 10 (mid dose) and 50 (high dose) mg/mL, respectively. The homogeneity and active ingredient content of the test substance in corn oil was within the allowable limit of ± 15% of nominal concentration.
- Duration of treatment / exposure:
- 6 h
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 mg/kg bw/day
- Remarks:
- G2 (Low dose)
- Dose / conc.:
- 10 mg/kg bw/day
- Remarks:
- G3 (Mid dose)
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- G4 (High dose)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No abnormality was observed in any animal during the detailed physical examination of animals.
- Dermal irritation:
- no effects observed
- Description (incidence and severity):
- No local skin reaction was observed in any treatment group during the study period.
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality or morbidity was observed in any group throughout the study period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No statistically significant changes in mean body weight and body weight change were observed in any treatment group when compared to the control group throughout the study period.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- A statistically significant increase (27.49%) in mean food consumption was observed in the female rats of the high dose group (G4-50 mg/kg b. wt.) during day 1-8 when compared with the control group (G1-0 mg/kg b. wt.) which was not considered as a treatment-related finding as this was not observed during subsequent periods of the study.
No other differences in the mean food consumption were observed for male and female rats of treatment groups compared to control group during the study. - Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No ophthalmological changes were observed in male and female rats of any group.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A statistically significant increase (23.71 %) in platelet count of male rats from the mid dose group (G3) and decrease (17.50 %) in female rats of the high dose group (G4) was observed when compared with the control group. These variations observed in platelet counts were either inconsistent or not dose-dependent and, hence, were not considered as treatment-related findings. All other haematological parameters among different dose groups were comparable with the control group.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Statistically significant increase in albumin level (4.89 %) and ALB:GLB ratio (33.53 %), and a reduction (21.46 %) in globulin level of male rats from the high dose group (G4) were observed when compared with the control group. These changes were within historical control data of testing laboratory (albumin: 4.33-5.11 g/dL, globulin: 1.24-3.34 g/dL and ALB:GLB ratio:1.38 - 3.99) hence, all these variations were not considered as treatment-related findings. All other clinical chemistry parameters among different dose groups were comparable with the control group.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- All the urine analysis parameters in both males and females from the treatment (G2 to G4) groups were comparable with the control (G1) group.
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The terminal body weight, absolute organ weight and relative organ weight in all the animals belonging to all the treated groups (G2 to G4) were comparable with the control group (G1). However, although not statistically significant, there was slight increase (8.26% and 6.80% in males and females, respectively) in absolute liver weight of the animals belonging to the high dose group (G4). This change was of slight magnitude without an evidence of any histopathological finding and thus, was considered not related to the treatment with the test item.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- External and internal examination of terminally sacrificed animals did not reveal any lesions of pathological significance.
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Microscopic examination did not reveal any treatment related lesion of pathological significance.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
Applicant's summary and conclusion
- Conclusions:
- 21-Day Dermal Rat NOAEL (male/female): ≥50 mg/kg b. wt./day
- Executive summary:
The study was conducted to determine the systemic toxicity potential of the test substance in Wistar rats following 21 days of repeated dermal exposure. This study was performed as per the requirements of guidelines of European Commission for repeated dose (28 Days) toxicity (Dermal), January 1997, guideline of OECD N° 410 (May 12, 1981) and guideline of US EPA OPPTS 870.3200 (August 1998).
A total of 20 male and 20 female Wistar rats were randomly allocated into four groups. Each group comprised 5 male and 5 female rats. Not less than 10 percent of the body surface area was clipped free of hair 24 h prior to the first dermal application of the test substance and weekly thereafter. One group (G1) served as the control and was treated with corn oil at a dose volume the same as that used for the high dose group. The other groups were treated at the dose levels of 2 mg/kg b. wt./day (G2), 10 mg/kg b. wt./day (G3) and 50 mg/kg b. wt./day (G4) of the test substance through dermal application. The test substance was applied over the clipped area by a single dermal application and was held in contact with the skin using porous gauze dressing and a non-irritating tape throughout the 6 h of exposure every day to prevent any loss of the test substance and also to ensure that the animals did not lick or ingest it. At the end of the exposure period, the residual test substance was removed using cotton moistened with corn oil. The fixed dose volume of 1 mL/kg b. wt. was used to dose each of the animals. The dose formulations were prepared by dissolving the test substance in corn oil. The dose formulation analysis was performed on day 1.
Each rat was observed for visible signs of reaction to treatment and for morbidity and mortality twice daily during the treatment period. All animals were observed for local skin reaction once daily as per protocol. The detailed clinical observations were performed before commencement of study and at weekly intervals until terminal sacrifice. Body weight was recorded on day 1 (prior to treatment) and at weekly intervals thereafter during the treatment period. Food consumption was calculated at weekly intervals until terminal sacrifice.
Ophthalmological examination was performed on all animals prior to commencement of treatment and prior to terminal sacrifice. Haematology, clinical chemistry investigation and urinalysis were performed on day 22 for all animals following an overnight fast.
All the terminally sacrificed rats were subjected to a detailed gross pathological examination. Absolute organ weights were recorded and relative organ weights were calculated for the organs viz., adrenals, brain, epididymides, heart, kidneys, liver, ovaries, spleen, testes, uterus, thyroid and parathyroid and thymus for all rats. Histopathological examination was carried out for the organs and tissues of G1 (control) and G4 (high dose group). As microscopic findings were observed in the livers of high dose group animals, histopathological examination was extended to the low and mid dose groups.
No mortality was observed during the study period. No clinical signs were observed in any animal from any of the groups.
No significant changes were observed in mean body weight and percent body weight change of male and female rats treated with the test substance in the low dose, mid dose and high dose groups when compared with the control group throughout the study period.
No treatment-related changes were observed in mean food consumption for treatment groups when compared with the control group.
No treatment-related alterations were observed in clinical pathology estimations for treatment groups when compared with the control group.
No significant changes were observed in mean terminal body weights, absolute organ weights and relative organ weights of animals from low dose, mid dose and high dose groups when compared with the control group.
External and internal examination of terminally sacrificed animals did not reveal any lesions of pathological significance. Microscopic examination did not reveal any treatment related lesion of pathological significance.
Based on the results of this study, it is concluded that the test substance did not produce any local as well as systemic adverse, treatment-related effects upto the dose level of 50 mg/kg b. wt./day after repeated dermal application for 21 days in Wistar rats. Hence, the NOAEL for the test substance is considered as ≥50 mg/kg b. wt./day under the conditions and procedures followed in the present study.
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