Rhamnolipids: fermentation products of glucose with Pseudomonas putida, Pseudomonadaceae

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-09-19 to 2016-11-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 27 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria

EC Number:

943-175-7

IUPAC Name:

Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9-11 weeks
- Weight at study initiation: step 1: 165-169g; step 2: 165-174g
- Fasting period before study: 16-19 hrs
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): ad libitum, standard chow (Altromin 1324)
- Water (e.g. ad libitum): ad libitum; tap water , sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x /h
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Step 1: 3 animals and step 2: 3 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing was performed on day 1, 8 and 15, observations of clinical signs were performed once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 5 000 mg/kg bw

Based on:

act. ingr.

Mortality:

no mortality occurred

Clinical signs:

other: No specific findings during the whole observation period.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The present study was performed in order to determine the LD50 of Rhamnolipids. No premature deaths occurred and no adverse effects were observed during cage side observations and final gross necropsy. Thus, Rhamnolipids is not classified according to GHS criteria.

Executive summary:

In an acute oral toxicity study according to OECD Guideline 423 (2001) and EU method B.1 tris (2008), groups of fasted, 9-11 weeks old female Wistar rats (2 steps, 3 animals per step) were given a single oral dose of Rhamnolipid (88.1% a.i.) in sterile water at a doses of 2000 mg/kg bw and observed for 14 days.

The test item showed no mortality and no other acute oral toxicity characteristics after a single dose administration. No specific clinical sings were observed during the whole observation period. None of the animals showed weight loss during the observation period. No specific gross pathological changes were recorded for any animal.

According to the guideline, the LD50 cut-off(rat) is >5000 mg/kg bw