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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:
not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.1
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-morpholin-4-ylpropane-1-sulfonate
EC Number:
428-420-3
EC Name:
Sodium 3-morpholin-4-ylpropane-1-sulfonate
Cas Number:
71119-22-7
Molecular formula:
C7H14NNaO4S
IUPAC Name:
sodium 3-(morpholin-4-yl)propane-1-sulfonate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
No further information provided in SNIF.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
No further information provided in SNIF.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
No further information provided in SNIF.
Statistics:
No information provided in SNIF.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
No mortality was observed.
Clinical signs:
other: Pilo-erection and/ or hunched posture were observed in 8 animals 4 h after treatment. No other signs of systemic toxicity were noted during the study.
Gross pathology:
No macroscopic abnormalities were recorded after necropsy of all animals at the end of the study.
Other findings:
No further information provided in SNIF.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was determined to be > 2000 mg/kg bw in male and female rats after oral treatment with the test item.
Executive summary:

In an acute oral toxicity study conduced using the standard acute methods each five male and female rats were treated with the test item. All animals received 2000 mg/kg bw of the test item. No mortality was observed.Pilo-erection and/ or hunched posture were observed in 8 animals 4 h after treatment. No other signs of systemic toxicity were noted during the study.No macroscopic abnormalities were recorded after necropsy of all animals at the end of the study. Based on these observations the LD50 was determined to be higher than 2000 mg/kg bw in rats.