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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (adopted 1987)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
(Harlan Laboratories Ltd)
Test type:
standard acute 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:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd.
- Age at study initiation: 9 (males) or 11 weeks (females)
- Weight at study initiation: 245-258 g (males) and 190-205 g (females)
- Housing: individually
- 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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% of the total body surface (one day before treatment, the backs of the animals were clipped with an electric clipper; re-shaved on test days 6, 9 and 13)
- % coverage: semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
- Washing: dressing was removed and the skin was washed up with lukewarm tap water and dried with disposable paper toweis

TEST MATERIAL
undiluted test substance
Duration of exposure:
24 h
Doses:
7.12 mL of the liquid Biofert Plusz corresponding to 2000 mg/kg bw dry mass
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations (clinical signs including local effects): Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were reeorded.
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15.
- Necropsy: yes, at termination (day 15)
- Other examinations performed: no
Statistics:
not used

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: dry mass
Remarks on result:
other: dose corresponds to 7.12 mL/kg bw of the liquid test substance; no clinical signs, no relevant effects on body weight, no findings at necropsy
Mortality:
no mortality
Clinical signs:
other: No clinical signs observed during the course of the study.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
no

Applicant's summary and conclusion

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