Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

EC Number:

279-317-3

EC Name:

Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

Cas Number:

79828-43-6

Molecular formula:

C38H18Cl2CrN16O20S4.5Na

IUPAC Name:

Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animal: Rat, KFM-Han, Wistar (outbred, SPF-quality);
Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerlan;
Number of animals: 5 males and 5 females; Total number: 10 males and 10 females;
Age of start of treatment: 9-11 weeks;
Body weight at start of the treatment: males:203-240g and female: 181-212 g.
Identification: by unique cage number and corresponding color-coded spots;
Randomization: randomly selected at time of delivery in groups of five.
Acclimation: at least one week under laboratory conditions, after veterinary examination.
Environmental conditions: Standard laboratory conditions: air-conditioned with 10-15 air changes per hour, and hourly monitored environment with temperature 22±3 °C, relative humidity 40-70 %, 12 hours artificial fluorescent light/12 hours dark, music/light period.
Accommodation: Group of five in Makrolon type-3 cages with standard softwood bedding. The cages were cleaned twice weekly during the test period.
Diet: Pelleted standard Kliba 343, batch 36/85 rat maintenance diet available ad libitum.
Water: community tap water from Itingen, available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The animals received the test article on a mg/kg body weight base by oral gavage after being fasted for 12 to 18 hours (access to water was not interrupted). Food was again presented approximately one hour after dosing.

Doses:

20 ml at 3000 mg/kg bw (group 1) and 5000 mg/kg (group 2) bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

FAT 40210/A was administered to rats of both sexes (5 male and 5 female for each group) by oral gavage at doses of 3000 and 5000 mg/kg bw and death rate, symptoms and necropsy were observed and the acute oral toxicity of FAT 40210 was estimated.

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

0 % at 3000 mg/kg bw and 10 % at 5000 mg/kg bw

Clinical signs:

other: 3000 mg/kg bw: sedation, dyspnoea, curved body position, ruffled fur, extremities blue to black discoloured. 5000 mg/kg bw: sedation, dyspnoea, ataxia, curved body position, ruffled fur, extremities blue to black discoloured. The rats had recovered from t

Gross pathology:

3000 mg/kg bw - killed: Stomach: partly blue discoloured (10); Kidneys/skin: dark-blue discoloured (5), blue discoloured (5);
5000 mg/kg bw - dead: Lung: blue discoloured, slight (1); Stomach/Intestines: blue to black discoloured, severe (1); adipose tissure: blue discoloured, slight (1);
5000 mg/kg bw- males: Stomach: blue discoloured (9); Intestines: blue discoloured slight (9); Urinary bladder, kidneys, skin: blue discoloured (9). Testis: blue discoloured (4); Uterus: blue discoloured (5).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of FAT 40210/A in rats of both sexed, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg bw.

Executive summary:

A key study was performed to determine the oral acute toxicity in rats according to OECD Guideline 401 (Acute Oral Toxicity).

The test article FAT 40210/A was administered to rats of both sexes by oral gavage, at doses from 3000 to 5000 mg/kg bw. The following death rate was observed: 0 % at 3000 mg/kg bw and 10 % at 5000 mg/kg bw. The LOGIT-Model could not be applied to these data. And the acute oral toxicity of FAT 40210/A in rats of both sexed, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg bw, which shall not be classified according to CLP Regulation (Regulation [EC] No. 1272/2008).