Rhamnolipids: fermentation products of glucose with Pseudomonas putida, Pseudomonadaceae

Endpoint summary

Description of key information

In a study according to OECD guideline 423, GLP, Reliability 2, the LD₅₀ of Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria in the female ratswas estimated as being greater than  2000 mg/kg bw). 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 27 December 2001

Deviations:

no

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

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

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

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.

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the criteria laid down in CLP regulation, the substance Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria is not classified for acute toxicology.