7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate

EC Number:

228-589-1

EC Name:

Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate

Cas Number:

6300-50-1

Molecular formula:

C22H17N5O7S2.2Na

IUPAC Name:

disodium 7-amino-4-hydroxy-3-({4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-2-sulfonate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Adult, young, albino, Wistar ITA177 SPF strain are used. Rats have been bred and kept in rooms with spf conditioning. The temperature is 24+-1 ° C and the humidity is 65+-5%.
The lighting is artificial, following periods of light and darkness of 12 h.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

All rats remain fasting approximately 18 hours before and 4 hours after administration. The rest of the time they received UAR D-04 sterilized feed and demineralised water "as libitum".
Rats are administered orally by means of a esophageal probe, the product suspended or dissolved in a solution of 1% tween 80 and 2% carboxymethylcellulose in distilled water.
Liquid products, if possible, are given undiluted.
Dose levels are chosen in progression and the products are administered according to the individual body weights of the rats (mg / kg or ml / kg).
The maximum dose used is 16 mg / kg or 16 ml / kg. The volume administered when using vehicle is 10 ml / kg. At high doses, the volume can be increased to a maximum of 40 ml / kg to facilitate the suspension of the product.
The control group receives only vehicle at the maximum volume administered.

Doses:

4 mg/kg bw, 8 mg/kg bw, 11.3 mg/kg bw, 16 mg/kg bw

No. of animals per sex per dose:

10 animals per dose

Control animals:

yes

Details on study design:

Body weights are recorded for each rat immediately prior to administration, and thereafter at weekly intervals.
Animals are often observed on the day of the administration, and then at least once a day for 14 days.
Symptoms of reaction to treatment are recorded in terms of approximate time of onset, duration and intensity.
The circumstances of each death are recorded and the autopsy performed, which includes the opening of the abdominal and thoracic cavities, as well as the cranial cavity if the observations indicate neurotoxic activity. The organs are examined microscopically and the observed alterations are noted.
All surviving animals at the end of the observation period are sacrificed and undergo the same autopathic examination.
The 14-day observation period will be extended if the general condition of the animals is not considered satisfactory or if delayed toxicity is noted.
The LD50 value is calculated from the mortality data found using the method of Litchfield and Wilcoxon.

Results and discussion

Preliminary study:

The preliminary study has an experimental design similar to the one of the study, but using a smaller number of animals (2 males and 2 females per group).
If the LD50 is found to be equal to or greater than 16 g / kg (16 ml / kg in the case of liquid) during the preliminary study, the exact value of LD50 is not determined.
If LD50 is found to be only slightly lower than 16 g / kg (16 ml / kg in the case of liquids), its value is determined even if four dose levels are not administered.

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

14.8 mL/kg bw

Based on:

act. ingr.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 516 mg/kg bw

Based on:

act. ingr.

Mortality:

The day after the adminsitration the observed mortality was:
Dose 16ml/kg: 60% (4 males, 2 females)
Dose 11,3 ml/kg: 20% (1 male, 1 female)
Dose 8 ml/kg: 10% (1 male)
Dose 4 ml/kg: 0%

Clinical signs:

other: Not observed

Gross pathology:

Not observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance has been found to have a LD50 of 14.8 (11.3-19.3) ml / kg when administered orally.
Rats died on the first day after administration without showing external signs of toxicity. There were no macroscopic alterations at autopsies.