Registration Dossier
Registration Dossier
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EC number: 407-550-4 | CAS number: 69184-17-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Adopted on 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Adopted on 1984.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl O-(4-amino-3,5-dichloro-6-fluoropyridin-2-yloxy)acetate
- EC Number:
- 407-550-4
- EC Name:
- Methyl O-(4-amino-3,5-dichloro-6-fluoropyridin-2-yloxy)acetate
- Cas Number:
- 69184-17-4
- Molecular formula:
- Hill formula: C8 H7 Cl2 F N2 O3 CAS formula: C8 H7 Cl2 F N2 O3
- IUPAC Name:
- methyl 2-[(4-amino-3,5-dichloro-6-fluoropyridin-2-yl)oxy]acetate
- Details on test material:
- - Name of test material (as cited in study report): Fluroxypyr methyl ester
- Physical state: dark grey powder
- Analytical purity: 90.8%
- Purity test date: 28.08.1990
- Lot/batch No.: C-3B
- Expiration date of the lot/batch: August 1992
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Kent, England
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 117-137 g
- Fasting period before study: overnight prior and approx. 4 h after dosing
- Housing: in groups of up to five rats of the same sex in metal cages with wire mesh floors
- Diet (ad libitum): Biosure LAD 1
- Water (ad libitum): potable water
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 56 (mean)
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% w/v
- Amount of vehicle (if gavage): 10 mL/kg - Doses:
- 5000 mg/kg bw
- 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: twice daily / weekly
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths were observed.
- Clinical signs:
- Pilo-erection was observed in all rats within five minutes of dosing. This sign persisted and was accompanied within two hours of treatment by:
abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and pallor of the extremities in all rats.
Recovery, as judged by external appearance and behaviour, was complete by Day 2. - Body weight:
- A slightly low bodyweight gain was recorded for one female on Day 15, this rat achieved an anticipated gain on Day 8. All other rats achieved anticipated bodyweight gains throughout the study.
- Gross pathology:
- No macroscopic abnormalities were detected.
Any other information on results incl. tables
Table 1: Clinical signs |
||
Signs |
No of rats showing signs |
|
male |
female |
|
Pilo-erection |
5 |
5 |
Abnormal body carriage (hunched posture) |
5 |
5 |
Abnormal gait (waddling) |
5 |
5 |
Lethargy |
5 |
5 |
Pallor of extremities |
5 |
5 |
Table 2: Individual and group mean bodyweights (g) |
||||
Sex |
Animal No. |
Bodyweight (g) at |
||
Day 1 |
Day 8 |
Day 15 |
||
male |
1 |
136 |
229 |
304 |
2 |
137 |
235 |
304 |
|
3 |
119 |
208 |
277 |
|
4 |
117 |
198 |
254 |
|
5 |
121 |
198 |
257 |
|
Mean |
126 |
214 |
279 |
|
female |
6 |
118 |
179 |
207 |
7 |
124 |
181 |
199 |
|
8 |
121 |
178 |
206 |
|
9 |
124 |
181 |
210 |
|
10 |
119 |
171 |
198 |
|
Mean |
121 |
178 |
204 |
|
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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