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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
2005-10-05 to 2005-07-05
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:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
L-valine
EC Number:
200-773-6
EC Name:
L-valine
Cas Number:
72-18-4
Molecular formula:
C5H11NO2
IUPAC Name:
L-valine

Test animals

Species:
rat
Strain:
other: Wistar outbred rat; Crl:(W1) WU BR
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 152 - 169 g
- Fasting period before study: overnight
- Housing: Maximum of 6 animals per macrolon cage
- Diet (e.g. ad libitum): Ad libitum approx. 4 h after dosing
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
according to guideline

IN-LIFE DATES: From: 2005-06-01 To:2005-06-21

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage):1.5 to 1.7 ml

MAXIMUM DOSE VOLUME APPLIED: 1.7 ml

Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Before dosing, day 3, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
other: No clinical signs observed.
Gross pathology:
No distinct treatment-related gross alterations

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
L-valine did not cause any mortality in an acute oral toxicity study according to OECD 423. LD50 derived from this limit test was > 2000 mg/kg bw.