C.I. Solvent Red 119

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June-August 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C.I. Solvent Red 119

EC Number:

602-676-8

Cas Number:

12237-27-3

Molecular formula:

C32H22N10O8Cr

IUPAC Name:

C.I. Solvent Red 119

impurity 1

Reference substance name:

Unknown impurities

Cas Number:

not available

IUPAC Name:

Unknown impurities

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: feed

Vehicle:

olive oil

Doses:

2000mg/kg

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

In compliance wih study plan.

Results and discussion

Preliminary study:

No

Effect levels

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

Mortality:

0

Clinical signs:

other: 0

Gross pathology:

n.a.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Solvent Red 119 is greater than 2000 mg/kg body weight after single oral
administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD
Guideline 423 it can be concluded that the test item Solvent Red 119 is classified in Category
5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single
oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item Solvent Red 119

when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of

2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test itemrelated

mortality was not observed during 24 hours and therefore in a next step 3 females were treated

with the same dose. All 6 females survived the limit dose. The limit dose of 2000 mg/kg body weight

did not cause death or evident signs of toxicity.

Stagnation of body weight in one animal between the first and second week was observed. During

necropsy, no macroscopic findings were observed.

The LD50 of the test item Solvent Red 119 is greater than 2000 mg/kg body weight after single oral

administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD

Guideline 423 it can be concluded that the test item Solvent Red 119 is classified in Category

5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single

oral administration to Wistar rats.

Summary Results

The test item Solvent Red 119 was administered to 6 females at a limit dose of 2000 mg/kg. This

dose did not produce any adverse changes in body weight, and did not cause any increase in mortality.

Stagnation of body weight in 1 animal between the first and second week was observed.

No signs of toxicity were observed at the dosage of 2000 mg/kg during the first 4 hours in females or

the 14-day observation period thereafter. During necropsy, no macroscopic findings were observed.