C.I. Reactive Yellow 161

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 - 18 Jul 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

EEC Directive 79/831 4.1.1

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

400-640-4

EC Name:

-

Cas Number:

198153-89-8

Molecular formula:

C32ClH25N10Na2O9S3

IUPAC Name:

disodium 2-(4-{[4-({3-[2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]-4-sulfonatophenyl}amino)-6-chloro-1,3,5-triazin-2-yl]amino}phenyl)-6-methyl-1,3-benzothiazole-7-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Yellow 161

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin). The animal room was air conditioned: temperature 22±3° C, relative humidity 55+/-15%, 12 hours light/day, approximately 15 air changes/h.

Diet: rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.

Initial body weight: 168 - 201 g
Initial age: 7 - 8 weeks

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

20 mL/kg bw applied (one single dose)

Pretreatment: the animals were allocated to the different dose groups by random selection. Prior to dosing, the animals were fasted overnight.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily, once on weekend days (symptoms); days 1, 7, 14, death (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

N/A

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred

Clinical signs:

other: Dyspnoea, exophthalmus, ruffled fur and curved body position being common symptoms in acute tests were seen in both sexes. In addition, the males showed transient sedation and diarrhea.

Gross pathology:

No effect in both sexes

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 (oral, gavage) in male/female rats was determined >5000 mg/kg bw. The substance is not classifiable according to CLP criteria.