C.I. Reactive Yellow 161

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 - 19 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 402 (Acute Dermal Toxicity)

Version / remarks:

EEC Directive 79/831 4.1.3

GLP compliance:

yes

Test type:

standard acute 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: 194 - 295 g
Initial age: 7 - 8 weeks

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

The required amount of the test substance was evenly dispersed on the skin.It was covered with a gauze lined occlusive dressing, which was fastened around the trunk with an adhesive elastic bandage. After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the reaction of the skin was appraised repeatedly.

Duration of exposure:

14 days

Doses:

2000 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:

> 2 000 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 were seen, being common symptoms in acute tests. In addition, ventral body position was observed during the administration period. A transient local erythema was noted on the site of administrat

Gross pathology:

Male: enlarged liver
Female: none

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 (dermal, occlusive) in male/female rats was determined >2000 mg/kg bw. The substance is not classifiable according to CLP criteria.