Octasodium 7,7'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(carbamoylamino)]-4,1-phenylene]azo]]bis(naphthalene-1,3,6-trisulphonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 15 to Febraury 1, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Yellow 084

IUPAC Name:

Reactive Yellow 084

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF breeding, VELAZ s.r.o.
- Age at study initiation: 8 weeks
- Housing: 3 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE: aqua pro iniectione, lot/batch 1703240253

MAXIMUM DOSE VOLUME APPLIED: 1 ml/100 g bw

CLASS METHOD
- Rationale for the selection of the starting dose: 300 mg/kg bw because no information about toxicity was known.

Doses:

group 1: 300 mg/kg
group 2: 2000 mg/kg
group 3: 2000 mg/kg

No. of animals per sex per dose:

3 females per group

Control animals:

no

Details on study design:

Body weight recording
Animals were weighed before application, at the 8th day of study and at the 15th day, before euthanasia of animals. Average body weight in a group was calculated from individual body weights. Body weight increments were calculated from body weight at the start of the study, the first week and at the end of the study.

Clinical examination
After application the animals were observed individually:
- the first day: twice (30 minutes and 3 hours after application)
- the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days.
Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system. The results of the observations were recorded on special data sheets.

Pathological examination
All test animals survived to the end of study were sacrificed on the 15th day and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded on special data sheets.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: No clinical signs of intoxication were seen in 9 females during clinical observation after application.

Gross pathology:

No changes.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg.

Executive summary:

Method

Acute oral toxicity was assessed using acute toxic class method, as described in OECD guideline 423. Group of 3 female rats were dosed at 300 mg/kg, 2000 mg/kg and 2000 mg/kg by gavage. Observations for mortality, clinical signs of intoxication, body weight changes and necropsy findings were done.

Results

Test substance caused no deaths, no serious clinical signs of intoxication and no pathologic macroscopic changes. Weight increments were adequate to species, sex and age of animals.