Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Kouseisho-21 Yakuhatsu-424
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
L-serine
EC Number:
200-274-3
EC Name:
L-serine
Cas Number:
56-45-1
Molecular formula:
C3H7NO3
IUPAC Name:
L-serine

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Sprague-Dawley strain SPF rats [Crl:CD(SD)]
- Test period: 2007.10.17 - 2008.01.31

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
L-Serine was administrated once each to groups of 5 males and 5 female Sprague-Dawley strain SPF rats [Crl:CD(SD)] at one dose level of
2,000 mg/kg.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred in males and females in any test article group. Therefore, the lethal dose level was estimated to be higher than 2,000 mg/kg for
L-serine.
Clinical signs:
There were no abnormalities in clinical signs in any male or female animal during the observation period.
Body weight:
All male and female animals showed nearly normal body weight development during the observation period.
Gross pathology:
There were no abnormalities in the external appearance, or in organs/tissues in the cranial, thoracic or abdominal regions in any male or female
animals.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Based on the results of the study report, it was estimated that the toxicity of L-serine was extremely low.