5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfophenyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 28, 2016 to February 24, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfophenyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts

EC Number:

943-066-4

Molecular formula:

Not applicable; this UVCB substance contains: C27H19ClN7O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 753.9 < MW < 802.0 g/mol (UVCB substance) and traces of NaCl.

IUPAC Name:

5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfophenyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: Crl:WI Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

- Source: Charles River Laboratories Research Models and Services
- Age at study initiation: 8 week old
- Housing: three animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5-6 days
- Photoperiod: 12-hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Distilled water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

three

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

CJ305 did not cause mortality.

Clinical signs:

All animals were observed that liquid faeces, reddish coloured faeces, reddish coloured urine on Day 0 and Day 1. From Day 2 up to the end of the observation period all animals were symptom-free.

Body weight:

Body weight gains of CJ305 treated animal were increased during the study.

Gross pathology:

No external observations and No internal observations were recorded. The observations of Organ and Tissue were not applicable.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

According to OECD 423 test method, the LD50 value of CJ305 was above 2000 mg/kg. Therefore, CJ305 was Category 5 or Unclassified based on GHS criteria.

Executive summary:

This test using the procedures outlined in the CiToxLAB Study Plan for 16/377-001P and OECD 423 (OECD, 2008). A total of 6 female Crl:WI rats were orally dosed with CJ305 in two dose steps of three animals each, at 2000 mg/kg bw for both Group 1 and Group 2. All animals in the two dose steps tolerated the test article well with increasing body weights and no mortality reported. The clinical signs observed that liquid faeces, reddish coloured faeces, reddish coloured urine on Day 0 and Day 1. From Day 2 up to the end of the observation period all animals were symptom-free. In absence of mortality, other significant clinical and gross signs of toxicity, these results place CJ305 in the GHS Category 5 or Unclassified, the LD50 value of CJ305 was above 2,000 mg/kg.