Registration Dossier
Registration Dossier
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EC number: 275-833-8 | CAS number: 71675-87-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 October 2014 - 4 November 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 4-amino-5-(ethylsulphonyl)-o-anisic acid
- EC Number:
- 275-833-8
- EC Name:
- 4-amino-5-(ethylsulphonyl)-o-anisic acid
- Cas Number:
- 71675-87-1
- Molecular formula:
- C10H13NO5S
- IUPAC Name:
- 4-amino-5-(ethanesulfonyl)-2-methoxybenzoic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Name of test material (as cited in study report): 4-amino-5-(ethylsulphonyl)-o-anisic acid
- Physical state: Solid
- Analytical purity: 99.81%
- Lot/batch No.: MP1032.31
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- (Crl: WI(Han); outbred)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Medicine Centre at the Medical University in Białystok
- Age at study initiation: 11 week-old
- Weight at study initiation: average body weight:197.8 g
- Fasting period before study: about 19 hours before the administration of the test item, restored 3 hours after the administration
- Housing: plastic cages covered with wire bar lids, 58 x 37 x 21 cm, with UV-sterilized wood shavings as bedding.
- Diet (e.g. ad libitum): ad libitum, "Murigran" standard granulated laboratory food.
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 ºC
- Humidity (%): 40-85%
- Air changes (per hr): 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60 mg/mL (dose of 300 mg/kg bw) or 400 mg/mL (dose of 2000 mg/kg bw)
- Amount of vehicle (if gavage): 1 mL
MAXIMUM DOSE VOLUME APPLIED: 0.5 mL/100 g bw
Rationale for the selection of the starting dose: The test item at a single dose of 300 mg/kg bw was administered to one animal. The starting dose for the sighting study was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg bw. Since no data was available, the sighting study commenced with the administration of the test item at a dose of 300 mg/kg bw to one female rat. No signs of toxicity were observed and the animal survived the experiment. A dose of 2000 mg/kg bw was administered to a second rat. No signs of toxicity were observed and the animal survived the experiment. On the grounds of the sighting study results, the dose of 2000 mg/kg b.w. was selected to be used in the main study. - Doses:
- Sighting study: 300 and 2000 mg/kg bw
Main study: 2000 mg/kg bw - No. of animals per sex per dose:
- 2 females in the sighting study.
4 females in the main study. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 0 (directly before the administration of the test item), 7, and 14 (before euthanasia).
- Necropsy of survivors performed: yes
- Other examinations performed:
General condition: observation of all animals for morbidity and mortality: twice a day or once a day (on days off) during the 14-day experiment.
Detailed clinical observations: on the day of the test item administration (day 0), i.e. 10, 30, and 60 minutes after the administration and then at hourly intervals up to the 5th hour after the administration. From the 1st to the 14th day of the experiment, the detailed clinical observations were performed once a day.
Gross examinations: After the 14-day observation period, all animals were euthanized by intraperitoneal administration of morbital at a dose of 200 mg/kg bw and subjected to gross examinations. The detailed gross examinations comprised the observation of the external body surface, all natural apertures, and the cranial, thoracic, and abdominal cavities with their contents.
Results and discussion
- Preliminary study:
- No signs of toxicity were observed and the animals survived the experiment.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the experiment.
- Clinical signs:
- other: No signs of toxicity were observed.
- Gross pathology:
- No pathological changes were stated.
Any other information on results incl. tables
Table No.1:
Dose of the test item (mg/kg b.w.) |
300 |
2000 |
|
Sighting study |
Sighting study |
Main study |
|
Mortality |
0/1 |
0/1 |
0/4 |
Clinical signs |
not found |
not found |
not found |
Table No.2: Clinical signs – overall list.
|
|
|
Animal number |
||||
Dose (mg/kg b.w.) |
Day after the administration |
Number of living animals |
1* |
2 |
3 |
4 |
5 |
300 |
0 |
1 |
NC |
- |
- |
- |
- |
1 |
1 |
NC |
- |
- |
- |
- |
|
2 |
1 |
NC |
- |
- |
- |
- |
|
3 |
1 |
NC |
- |
- |
- |
- |
|
4 |
1 |
NC |
- |
- |
- |
- |
|
5 |
1 |
NC |
- |
- |
- |
- |
|
6 |
1 |
NC |
- |
- |
- |
- |
|
7 |
1 |
NC |
- |
- |
- |
- |
|
8 |
1 |
NC |
- |
- |
- |
- |
|
9 |
1 |
NC |
- |
- |
- |
- |
|
10 |
1 |
NC |
- |
- |
- |
- |
|
11 |
1 |
NC |
- |
- |
- |
- |
|
12 |
1 |
NC |
- |
- |
- |
- |
|
13 |
1 |
NC |
- |
- |
- |
- |
|
14 |
1 |
NC |
- |
- |
- |
- |
|
2000 |
0 |
5 |
NC |
NC |
NC |
NC |
NC |
1 |
5 |
NC |
NC |
NC |
NC |
NC |
|
2 |
5 |
NC |
NC |
NC |
NC |
NC |
|
3 |
5 |
NC |
NC |
NC |
NC |
NC |
|
4 |
5 |
NC |
NC |
NC |
NC |
NC |
|
5 |
5 |
NC |
NC |
NC |
NC |
NC |
|
6 |
5 |
NC |
NC |
NC |
NC |
NC |
|
7 |
5 |
NC |
NC |
NC |
NC |
NC |
|
8 |
5 |
NC |
NC |
NC |
NC |
NC |
|
9 |
5 |
NC |
NC |
NC |
NC |
NC |
|
10 |
5 |
NC |
NC |
NC |
NC |
NC |
|
11 |
5 |
NC |
NC |
NC |
NC |
NC |
|
12 |
5 |
NC |
NC |
NC |
NC |
NC |
|
13 |
5 |
NC |
NC |
NC |
NC |
NC |
|
14 |
5 |
NC |
NC |
NC |
NC |
NC |
|
*the female from the sighting study
NC:no changes
Table No.3: Body weights of the animal - overall list
|
|
Day of the experiment / Body weight |
|
||
Dose (mg/kg b.w.) |
Animal number |
0 |
7 |
14 |
Body weight gain(g) (0→14) |
300 |
1* |
209 |
240 |
236 |
27 |
2000 |
1* |
202 |
234 |
229 |
27 |
2 |
199 |
215 |
227 |
28 |
|
3 |
199 |
219 |
230 |
31 |
|
4 |
201 |
213 |
229 |
28 |
|
5 |
188 |
207 |
213 |
25 |
|
* the female from the sighting study
Table No.4: Detailed clinical signs: Female Number 1 , 3000mg/kg bw
Parameter |
Day 0 of observation |
|||||||
10 min |
30 min |
1h |
2h |
3h |
4h |
5h |
||
Locomotor system, behaviour, reactions to stimuli |
1. Body posture |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Gait |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Locomotor activity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Involuntary movement-clonic |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Involuntary movement-tonic
|
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6.Reaction to being caught |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
7. Vocalization |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
8. Reaction to sound stimuli |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
9. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Skin and hair |
Skin colour |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Edema |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Epidermis |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Coat |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Skin changes |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Eyes and eyelids |
1. Ocular discharge |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Exophthalmos |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Corneal opacity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Eyelids |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Respiratory system |
1. Respiration |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Discharge from the nostrils |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Digestive system |
1. Salivation |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Diarrhea |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Bleeding from the anus |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Urinary system |
1. Urination |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Hematuria |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Reproductive system |
1. Pathological discharge from the reproductive tract |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
2. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
Table No.5:Detailed obseravation, dosage 300mg/kg b.w, female No.1
Date of euthanasia: 23.10.2014
Fasting: 18 hours
Animal age: 10 weeks
Parameter |
Day of observation |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
Locomotor system, behaviour, reactions to stimuli |
1. Body posture |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Gait |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Locomotor activity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Involuntary movement-clonic |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Involuntary movement-tonic
|
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6.Reaction to being caught |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
7. Vocalization |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
8. Reaction to sound stimuli |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
9. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Skin and hair |
Skin colour |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Edema |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Epidermis |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Coat |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Skin changes |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Eyes and eyelids |
1. Ocular discharge |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Exophthalmos |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Corneal opacity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Eyelids |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Respiratory system |
1. Respiration |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Discharge from the nostrils |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Digestive system |
1. Salivation |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Diarrhea |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Bleeding from the anus |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Urinary system |
1. Urination |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Hematuria |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Reproductive system |
1. Pathological discharge from the reproductive tract |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
2. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
Parameter |
Day of observation |
|||||||
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
Locomotor system, behaviour, reactions to stimuli |
1. Body posture |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Gait |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Locomotor activity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Involuntary movement-clonic |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Involuntary movement-tonic
|
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6.Reaction to being caught |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
7. Vocalization |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
8. Reaction to sound stimuli |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
9. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Skin and hair |
Skin colour |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Edema |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Epidermis |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Coat |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Skin changes |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Eyes and eyelids |
1. Ocular discharge |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Exophthalmos |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Corneal opacity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Eyelids |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Respiratory system |
1. Respiration |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Discharge from the nostrils |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Digestive system |
1. Salivation |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Diarrhea |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Bleeding from the anus |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Urinary system |
1. Urination |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Hematuria |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Reproductive system |
1. Pathological discharge from the reproductive tract |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
2. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
Gross lesions: not found
Table NO.6:Detailed opbservations, dose 2000mg/kg b.w, FEMALE NO.1,2,3,4 and 5
Fasting: 19 hours
Animal age: 11 weeks
Parameter |
Day 0 of observation |
|||||||
10 min |
30 min |
1h |
2h |
3h |
4h |
5h |
||
Locomotor system, behaviour, reactions to stimuli |
1. Body posture |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Gait |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Locomotor activity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Involuntary movement-clonic |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Involuntary movement-tonic
|
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6.Reaction to being caught |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
7. Vocalization |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
8. Reaction to sound stimuli |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
9. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Skin and hair |
Skin colour |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Edema |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Epidermis |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Coat |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Skin changes |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Eyes and eyelids |
1. Ocular discharge |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Exophthalmos |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Corneal opacity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Eyelids |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Respiratory system |
1. Respiration |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Discharge from the nostrils |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Digestive system |
1. Salivation |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Diarrhea |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Bleeding from the anus |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Urinary system |
1. Urination |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Hematuria |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Reproductive system |
1. Pathological discharge from the reproductive tract |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
2. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
Table No.7:
Detailed observations, dose 2000mg/kg b.w, FEMALE NO.1,2,3,4 and 5
Parameter |
Day of observation |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
Locomotor system, behaviour, reactions to stimuli |
1. Body posture |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Gait |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Locomotor activity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Involuntary movement-clonic |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Involuntary movement-tonic
|
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6.Reaction to being caught |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
7. Vocalization |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
8. Reaction to sound stimuli |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
9. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Skin and hair |
Skin colour |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Edema |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Epidermis |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Coat |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Skin changes |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Eyes and eyelids |
1. Ocular discharge |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Exophthalmos |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Corneal opacity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Eyelids |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Respiratory system |
1. Respiration |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Discharge from the nostrils |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Digestive system |
1. Salivation |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Diarrhea |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Bleeding from the anus |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Urinary system |
1. Urination |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Hematuria |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Reproductive system |
1. Pathological discharge from the reproductive tract |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
2. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
Parameter |
Day of observation |
|||||||
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
Locomotor system, behaviour, reactions to stimuli |
1. Body posture |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Gait |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Locomotor activity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Involuntary movement-clonic |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Involuntary movement-tonic
|
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6.Reaction to being caught |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
7. Vocalization |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
8. Reaction to sound stimuli |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
9. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Skin and hair |
Skin colour |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Edema |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Epidermis |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Coat |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Skin changes |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
6. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Eyes and eyelids |
1. Ocular discharge |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Exophthalmos |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Corneal opacity |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Eyelids |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
5. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Respiratory system |
1. Respiration |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Discharge from the nostrils |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Digestive system |
1. Salivation |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Diarrhea |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Bleeding from the anus |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
4. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Urinary system |
1. Urination |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
2. Hematuria |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
3. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
Reproductive system |
1. Pathological discharge from the reproductive tract |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
|
2. Other |
0 |
0 |
0 |
0 |
00 |
0 |
0 |
Table No.8: Body weight and date of euthanasia
Animal |
Weight 0 7 14 |
Day of euthanasia |
||
1 |
202 |
234 |
229 |
28.10.2014 |
2 |
199 |
215 |
227 |
4.11.2014 |
3 |
199 |
219 |
230 |
4.11.2014 |
4 |
201 |
213 |
229 |
4.11.2014 |
5 |
188 |
207 |
213 |
4.11.2014 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified
- Conclusions:
- No signs of toxicity were observed following single administration of the test item at a dose of 2000 mg/kg bw in rats. The discriminating dose was determined to be 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity study based on a fixed dose method was performed according to OECD Guideline 420. The sighting study in which the test item at a dose of 300 and 2000 mg/kg bw was administered by gavage to one animal and then to the second animal did not show any signs of toxicity. On the grounds of these results, four animals were given the test item at a dose of 2000 mg/kg bw in the main test. After the administration of the test item, the animals were observed for 14 days. General and detailed clinical observations were conducted daily during the entire experiment. Body weights of the animals were determined on days 0 (directly before the administration of the test item), 7, and 14. After the 14-day observation period, the animals were euthanized and subjected to a detailed gross examination. All animals survived the experiment. After the experiment, body weights of all animals increased. Gross examinations did not reveal any pathological changes.
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