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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:
2016-10-4 to 2016-10-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
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:
2-(4-morpholinyl)ethansulfonic acid hydrate
Cas Number:
1266615-59-1
Molecular formula:
C6H13NO4S * xH2O
IUPAC Name:
2-(4-morpholinyl)ethansulfonic acid hydrate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 187 - 192 g (1st step), 185-190 g (2nd step)
- Fasting period before study: 1 day
- Housing: group caging (3 rats/cage), Type II polypropylene/polycarbonate
- Diet: ad libitum, ssniff® SM R/M-Z+H complete diet for rats and mice
- Water: ad libitum, tap water
- Acclimation period: 5-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: standard vehicle
- Purity: aqua purificata Ph.Hg. VIII. from Parma Produkt Kft. (Batch no. 1606-5508)

MAXIMUM DOSE VOLUME APPLIED: 10 mL

CLASS METHOD
- Rationale for the selection of the starting dose: Selection was based on the basis of the available information about the test item and similar substances.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were observed at least once daily and weighted on days 0, 7 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, appearance of tissue and organs
- experimental design: the study was performed in two consecutive steps with three rats per step.
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: none
Gross pathology:
moderate to severe hydrometra, a physiological finding related to the cycle of the rats, was observed in two rats

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of the test substance is considered to be >2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 423. The study was conducted in two consecutive steps with three rats per step. All six female rats treated with 2000 mg/kg bw by oral gavage survived the observation period. No signs of toxicity were detected. The body weight development was normal. Gross pathology showed no test substance related alterations. The LD50 value of the test substance is considered to be >2000 mg/kg bw.