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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 September - 05 October 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-morpholinopropanesulphonic acid
EC Number:
214-478-5
EC Name:
4-morpholinopropanesulphonic acid
Cas Number:
1132-61-2
Molecular formula:
C7H15NO4S
IUPAC Name:
3-morpholin-4-ylpropane-1-sulfonic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report) : MOPS HIGH PURITY
- Physical state : white powder
- Analytical purity : 99,2%
- Purity test date : not stated
- Lot/batch No. : 05030139/131
- Storage condition of test material : room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source : Elevage JANVIER (53940 Le Genest St Isle — France)
- Age at study initiation : not stated
- Weight at study initiation : 184g - 208g
- Fasting period before study : not stated
- Housing : not stated
- Diet (e.g. ad libitum) : rats&mice maintenance diet
- Water (e.g. ad libitum) : not stated
- Acclimation period : at least 5 days

Group 1 (control) : 6 female rats Rf7051 to Rf7056
Group 2 (treated) : 3 female rats Rf7021 to Rf7023 ; 3 female rats Rf7034 to Rf7036

ENVIRONMENTAL CONDITIONS
- Temperature (°C) : between 19°C and 22°C
- Humidity (%) : between 37% and 56%
- Air changes (per hr) : not stated
- Photoperiod (hrs dark / hrs light) : not stated

Administration / exposure

Route of administration:
other: force-feeding
Vehicle:
other: distilled water
Details on oral exposure:
The animals received an effective dose of 2000 mg/kg body weight of item MOPS HIGH PURITY, diluted in distilled water and administered by force-feeding under a volume of 5 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
- 2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing : not further specified
- Necropsy of survivors performed: yes
- Other examinations performed :
* Spontaneous Activity
* Preyer's Reflex
* Respiratory Rate
* Convulsions
* Tremors
* Body Temperature
* Muscle Tone
* Palpebral Opening
* Pupil Appearance
* Salivation
* Lachrymation
* Righting Reflex
* Back Hair Appearance
• The observations are performed by comparison with the control animals standing in the same environment.
• The temperature of animal is evaluated by touch.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
For detailed necropsy data see attached full study report .

Any other information on results incl. tables

Table 1 :

OBSERVATION DATA SHEET No. 1— Group 1 (control)

Vehicle : Distilled water

Dose 0 mg/kg bw ; Day 0 : 27 September 2005

OBSERVATIONS  FEMALES                
T0 + 30 min. Rf 7051  Rf 7052  Rf 7053  Rf 7054  Rf 7055  Rf 7056 
T0 + 1 hour                                
T0 + 3 hours                                
T0 + 4 hours                 
Spontaneous activity 
Preyer´s reflex (noise)  N
Respiratory rate 
Convulsions 
Tremors 
Body temperature 
Muscle tone 
Palpebral opening 
Pupil appearance 
Salivation 
Lachcrymation 
Righting reflex 
Back hair appearance 
MORTALITY 
Remarks  None        None       

Table 2 :

OBSERVATION DATA SHEET No. 2 — Group 1 (control)

Vehicle : Distilled water

Dose 0 mg/kg bw ; Day 0 : 27 September 2005

OBSERVATIONS  FEMALES                
Day 1 to Day 14 Rf 7051  Rf 7052  Rf 7053  Rf 7054  Rf 7055  Rf 7056 
Spontaneous activity  N
Preyer´s reflex (noise)  N
Respiratory rate  N
Convulsions  N
Tremors  N
Body temperature  N
Muscle tone  N
Palpebral opening  N
Pupil appearance  N
Salivation  N
Lachcrymation  N
Righting reflex  N
Back hair appearance  N
MORTALITY 
Remarks  None        None       

Table 3 :

OBSERVATION DATA SHEET No. 1 — Group 2 (treated)

Test item : MOPS HIGH PURITY

Dose 2000 mg/kg bw ; Day 0 : 20 September 2005 & 21 September 2005

OBSERVATIONS         FEMALES                           
T0 + 30 min. Rf 7021  Rf 7022  Rf 7023  Rf7034  Rf7035  Rf7036 
T0 + 1 hour                 
T0 + 3 hours                 
T0 + 4 hours                 
Spontaneous activity   N
Preyer´s reflex (noise)  N  N
Respiratory rate   N
Convulsions   N
Tremors   N
Body temperature   N
Muscle tone   N
Palpebral opening   N
Pupil appearance   N
Salivation   N
Lachcrymation   N
Righting reflex   N
Back hair appearance   N
MORTALITY   0
Remarks  None None       

Table 4 :

OBSERVATION DATA SHEET No. 2 — Group 2 (treated)

Test item : MOPS HIGH PURITY

Dose 2000 mg/kg bw ; Day 0 : 20 September 2005 & 21 September 2005

OBSERVATIONS  FEMALES                
Day 1 to Day 14 Rf 7021  Rf 7022  Rf 7023  Rf 7034  Rf 7035  Rf 7036 
Spontaneous activity  N
Preyer´s reflex (noise)  N
Respiratory rate  N
Convulsions  N
Tremors  N
Body temperature  N
Muscle tone  N
Palpebral opening  N
Pupil appearance  N
Salivation  N
Lachcrymation  N
Righting reflex  N
Back hair appearance  N
MORTALITY 
Remarks  None        None       

Toxicity Lexicon

* Spontaneous Activity :Normal (N) 1 Decrease (D) 1 Increased (A)

* Preyer's Reflex :Normal (N) 1 None (0)

*Respiratory Rate :Normal (N) 1 Dyspnea (D) 1 Bradypnea (B) 1 Polypnea (P)

* Convulsions : None (N) 1 Tonic (T) 1 Clonic (C)

* Tremors :None (N) 1 Tremors (Tr)

* Body Temperature :Normal (N) 1 Hypothermia (D) 1 Hyperthermia (A)

* Muscle Tone : Normal (N) 1 Decreased (D) 1 Increased (A)

* Palpebral Opening :Normal (N)Eyes partly closed (Pc) Eyes completely closed (Cc)

* Pupil Appearance :Normal (N) 1 Mydriasis (Md) i Myosis (Ms)

* Salivation : Normal (N) 1 Increased (A)

* Lachrymation : Normal (N) 1 Increased (A)

* Righting Reflex :Normal (N) 1 Limited (D) 1 None (0)

* Back Hair Appearance :Normal (N) 1 Piloerection (Pi)

NOTES:

The observations are performed by comparison with the control animals standing in the same environment.

• The temperature of animal is evaluated by touch.

Table 5:

BODY WEIGHT EVOLUTION — GROUP 1 (Control)

Vehicle : Distilled water

Dose 0 mg/kg bw ; Day 0 : 27 September 2005

(Body weight and weight gain in grams)

FEMALES

D0

D2

D2 -D0

D7

D7-D0

D14

D14-D0

Rf 7051

182

204

22

218

36

229

47

Rf 7052

184

208

24

227

43

246

62

Rf 7053

178

204

26

220

42

238

60

Rf 7054

179

201

22

216

37

239

60

Rf 7055

188

212

24

221

33

247

59

Rf 7056

191

214

23

228

37

249

58

MEAN

183,7

207,2

23,5

221,7

38,0

241,3

57,7

Standard deviation

5,1

5,1

1,5

4,8

3,8

7,5

5,4

Table 6:

BODY WEIGHT EVOLUTION — GROUPS 2 (treated)

Test item : MOPS HIGH PURITY

Dose 2000 mg/kg bw ; Day 0 : 20 September 2005 & 21 September 2005

(Body weight and weight gain in grams)

FEMALES

D0

D2

D2-D0

D7

D7-D0

D14

D14-D0

Rf 7021

184

208

24

224

40

239

55

Rf 7022

188

208

20

230

42

240

52

Rf 7023

190

208

18

238

48

253

63

Rf 7034

199

220

21

241

42

257

58

Rf 7035

208

233

25

257

49

268

60

Rf 7036

201

218

17

234

33

255

54

MEAN

195,0

215,8

20,8

237,3

42,3

252,0

57,0

Standard deviation

9,1

10,0

3,2

11,3

5,8

11,0

4,1

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The study was performed according to the OECD TG423 and EU Method B.1 tris without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the item MOPS HIGH PURITY must not be classified.
Executive summary:

The item MOPS HIGH PURITY was administered to a group of 6 females Sprague Dawley rats at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated December 17th, 2001 and the test method B. 1 tris of the Directive N° 2004/73/EC. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

 In conclusion, the LD50 of the item MOPS HIGH PURITY is higher than 2000 mg/kg body weight by oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the item MOPS HIGH PURITY must not be classified.