Supernatant from the crystallisation of L-threonine from the broth filtrate from the fermentative production of L-threonine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD guideline 402 (adopted 1987). Study was originally judged Klimisch 1. However, according to the "Practical guide 6: How to report read-across and categories" the maximum score for read-across is 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Directive 92/69/EEC, B.3

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Biofert Plusz

IUPAC Name:

Biofert Plusz

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 - 11 weeks
-Weight at study initiation: 190 - 258 g
-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:

-Post-observation period: 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 recorded.
-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:

None

Clinical signs:

other: No adverse effects

Gross pathology:

No adverse effects

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The acute dermal toxicity of Biofert Plusz was tested in GLP study according to OECD guideline 402. In both male and female Wistar rats the dermal LD50 (related to dry mass) is > 2000 mg/kg bw