Reaction mass of 1,2-Benzenedicarboxylic acid, 3-sulfo-, ammonium salt (1:3), 4-Sulphophthalic acid, ammonium salt, Ammonium sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decaltal N

IUPAC Name:

Decaltal N

Details on test material:

- Name of test material (as cited in study report): Decaltal N
- Physical state: solid white
- Purity: 99.57%
- Composition of test material, percentage of components: 15.5 g/100 g (Tri ammonium 4-sulphonatophthalate), 4.5 g/100 g (Tri ammonium 3-sulphonatophthalate), 0.7 g/100 g (Di ammoniumphthalate), 78.4 g/100g (ammonium sulfate) 0.47 g/100 g (water) (as determined by 1H-NMR-spectroscopy)
- Lot/batch No.: 89273636W0
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 185 +/- 20%
- Fasting period before study: at least 16 hrs
- Housing: single housing
- Diet (e.g. ad libitum): VFR1(P)
- Water: Tap water ad libitum
- Acclimation period: at least five days before beginning of the experiment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg

Doses:

2000 mg/kg (in two independent experiments)

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: aniamls were weighed before administration, weekly thereafter and on the last day of the experiment; clinical observation was done several times at the day of test item application and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

n/a

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1/6 animals died

Mortality:

No mortality occurred in the first administration group.
One animal of the second test group died within one hour after application.

Clinical signs:

other: No clinical signs were observed during clinical examination in the first test group. In the second test group one animal showed poor general state, dyspnoea, piloerection and lateral position at hour 0 while two females of this dose group did not show any

Gross pathology:

There were no macroscopic pathological findings in the five animals sacrificed at the end of the observation period.
In the animal that died dark red discoloration of the liver, red discoloration of the glandular stomach and small intestine, liquid content in the stomach or the small intestine and congestion in the kidneys were observed.