Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate

Endpoint summary

Description of key information

Acute Oral Toxicity

LD50 = 11205 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From December 21 to February 02, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Supplier: Velaz Praha
- Weight: 150 g
- Health status: quality certification, checked frormparasite and patogen microrganisms, viruses and fungi- Housing: plastic cages in polypropilene T4 ( Velaz Praha), ventilated and bedding with pure light wood shavings
- Selection: 5 animals pro cage by gender- Identification: by number on cages and on tail
- Diet: Altromin 1320 (Velaz Praha), daily dose of 15 g
- Water: ad libitum, according to SN 757111
- Cleaning: disinfection of cages
- Acclimatization: quarantine
- Acclimatization period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature : 22 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod (hrs dark / hrs light): 12/12

Controlling of temperature and humidity automatic

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE 20 % aqueous solution was added to the appropriate amount of sample.
DOSAGE PREPARATION For the selected level logarithmic dose OVA Labor 751 05 was used.

Doses:

logaritmic doses:
6310; 7943; 10000; 12590; 15850 mg/kg bw

No. of animals per sex per dose:

Ten groups for avery gender

Details on study design:

- Observation after application: immediately after application, 30 minutes, 3 hours after application, the following morning and afternoon, and even days after at least once a day
- Period of observation: 14 days

CLINICAL OBSERVATION
- Mortality
- Hair, visible mucous membranes,psychic activity, somatomotor activity, response to stimuli with a focus on sensibilityand reactivity, lacrimation,respiration,digestive apparatus, urogenital apparatus.Animals that died during the experiment were dissected. Organs and muscle were examined macroscopically.Surviving animals after 14 dayswere killed and autopsied, organs and muscle macroscopically assessed. After exenteration of the Iiterior organs were assessed by their color, size, consistency and structure.Urine biochemical test focused on findings proteins, blood sugar, ketones, bilirubin, urobilinogen and pH was performed.Characteristics of the sample toxicity was calculated according to the assess evaluation of clinical symptoms of intoxication patomorfologic changes to mortality in the course of a 14-day experiment

Statistics:

Probit

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 11 205 mg/kg bw

Based on:

test mat.

Mortality:

6310 mg/kg bw: 0 death
7943 mg/kg bw: 1 male
10000 mg/kg bw: 2 female
12590 mg/kg bw: 4 male and 3 female
15850 mg/kg bw: 5 male and 5 female

Clinical signs:

other: other: other: No observations

Gross pathology:

No observations

Table 2. Dead animals

logaritmic doses	number on dead animals		%
g/kg	M	F
6 . 310	0	0	0
7 . 943	1	0	10
10 . 00	0	2	20
12.59	4	3	70
15 . 85	5	5	100

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 = 11205 mg/kg bw

Executive summary:

Method

The substance was tested for acute oral toxicity in rats Wistar strain according to OECD 401.

Logaritmic doses between 6310 and 1585 mg/kg bw were somministered and mortality was observed at the 14th day.

Clinical signs were observed and macroscopic autopsy was performed after the last somministration of 1585 mg/kg bw.

Urine biochemical test was also performed.

Characteristics of the sample toxicity was calculated according to the assess evaluation of clinical symptoms of intoxication patomorfologic changes to mortality in the course of a 14-day experiment.

Results

After 14 days of observation starting from the application the registering substances was defined as very weakly toxic with a LD50 = 11205 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

11 205 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

According to the CLP criteria n.1272/2008, the test substance is not classified as toxic for the oral exposure as its LD50 is > 2000 mg/kg bw.