Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline 423 (adopted 2001)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Remarks:
(Harlan Laboratories Ltd.)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
(2S)-2-amino-3-hydroxybutanoic acid
EC Number:
923-725-2
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
(2S)-2-amino-3-hydroxybutanoic acid
Details on test material:
- Name of test material (as cited in study report): Biofert Plusz
Details are presented in "Confidential details on test material"

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd.
- Age at study initiation: 11 weeks
- Weight at study initiation: 183.6 – 202.9 g
- Fasting period before study: fasted for approximately 17 to 18 hours
- Housing: In groups of three in Makrolon type-4 cages
- certified diet ad libitum
- tap water ad libitum
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
according to guideline

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: The dosing volume was 7.12 mL/kg body weight (only one dose level, undiluted test substance, corresponding to 2000 mg/kg bw dry mass).
Two groups of three animals each were trested. The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight (dry mass) after being fasted for approximately 17 to 18 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
Doses:
2000 mg/kg bw (dry mass)
No. of animals per sex per dose:
2 x 3 females
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations (clinical signs): Daily during the acclimatisation period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15.
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes
- No other examinations performed
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: related to dry mass
Remarks on result:
other: No clinical signs and no macroscopic findings at the limit dose
Mortality:
no
Clinical signs:
other: No clinical signs were observed during the course of the study.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In female Wistar rats the oral LD50 is > 2000 mg/kg bw (related to dry mass).