Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 July 2018 and 15 August 2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17th, 2001
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
30 May 2008
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
six female rats

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on oral exposure:
In the first and second step of the study, 2.0050 g and 2.0043 g of the test item were weighed and
distilled water was added to two 10 mL volumetric flasks. Just before the administration, the
preparations were stirred using a vortex during 30 seconds to dark red solutions.
Doses:
2000 mg/kg
No. of animals per sex per dose:
Group treated (2000 mg/kg): 3 female rats
Control animals:
yes
Remarks:
Clinical examinations: Nothing to report. Animal normal (3/3)
Details on study design:
This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the
observation sheet.
Statistics:
Systematic examinations were carried out to identify any behavioural or toxic effects on the major
physiological functions 30 min, 1h, 3h, 4h, 24h, 48h after administration of the test item and continued
daily during 14 days.

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. (dissolved fraction)
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat. (dissolved fraction)
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.
A pink coloration of wood shavings and faeces was noted at 24 and 48 hours post dose.
Body weight:
The body weight evolution of the animals remained normal during the study.
Gross pathology:
On D14, the animals were euthanized with sodium pentobarbital (Dolethal®).
Other findings:
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 LD50 of the test item Red EHS 237 is higher than 2000 mg/kg body weight.
In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be
considered as 5000 mg/kg body weight by oral route in the rat.