Reaction products of disodium hydroxysubstitutedpolycycledisulphonate reacted with 2,4,6-trichloro-1,3,5-triazine, subsequently coupled with diazotized 2-[(p-substitutedphenyl)sulphonyl]ethyl hydrogen sulphate, subsequently reacted with disodium hydroxysubstitutedpolycycledisulphonate and subsequently coupled with diazotized disodium substitutedpolycycledisulphonate

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 17th, 2001

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

GLP compliance:

yes (incl. QA statement)

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 or test system 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 levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat. (dissolved fraction)

Effect levels 2

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.