Ledum palustre, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 February 2016 to 02 March 2016

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

A relative humidity lower than 30% was registered on 17 & 18 February 2016 and on 01 March 2016. The minimum value measured was 23%. This deviation is considered as without impact on the conclusion of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Ledum palustre, extract

EC Number:

289-997-3

Cas Number:

90063-39-1

Molecular formula:

UVCB substance, not relevant.

IUPAC Name:

Ledum palustre, extract

Test material form:

liquid

Details on test material:

UVCB substance : see composition at section 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Six Sprague Dawley rats supplied by Elevage JANVIER LABS, were used after an acclimatization period of at least five days.
At the beginning of the study, the animals were 8 weeks old.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

administered by gavage using a suitable graduated syringe fitted with an oesophageal metal canula.

Doses:

The animals of the treated group received an effective dose of 2000 mg/kg body weight of the test item Teinture mère de Ledum palustre – code L12C.
In the first and second step of the study, the test item was administered by gavage under a volume of 2.27 mL/kg body weight (corresponding to 2 g/kg, according to the calculated relative density).

No. of animals per sex per dose:

6 female rats at 2000 mg/kg

Control animals:

yes

Details on study design:

Three animals, received the control item Distilled water, administered by gavage under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

In conclusion, the LD50 of the test item Teinture mère de Ledum palustre – code L12C is higher than 2000 mg/kg body weight by oral route in the rat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 5 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat.

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed during the study.

Body weight:

The body weight evolution of the animals remained normal during the study.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item Teinture mère de Ledum palustre – code L12C does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.