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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

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 levelsopen allclose all
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.
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.

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