Reaction products of diazotised 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid and 3-amino-4-hydroxy-5-nitrobenzenesulphonic acid, coupled with resorcinol, metalized with Ferric Chloride, condensed with Formaldehyde, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

November 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

study performed on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 1.

Justification for type of information:

Justification for read-across is detailed at section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Royal Decree 363/1995

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 142.6 males, 128.6 females
- Fasting period before study: overnight
- Housing: Tecniplast Makrolon cage (48 x 27 x 20 cm) with soft wood.
- Diet: free access to a diet for experimental rats, supplied by a authorized provider.
- Water: drinking water ad Iibitum by Makrolon bottles.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C (± 2 °C)
- Humidity: 55 % (± 25 %)
- Air changes: 15ACH filtered at 5 µm
- Photoperiod: 12 hours cycle dark/light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg of test item were dissolved in 20 ml of distilled water.
- Amount of vehicle: 2 ml per 100g b.w, equivalent to 2000 mg/kg b.w.

Doses:

2000 mg/Kg.

No. of animals per sex per dose:

3 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing:at 0, 7 and 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

No abnormal behaviour or signs of toxicity were observed.

Gross pathology:

No macroscopic changes were observed.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The LD50 (rat, oral) was found to be > 2000 mg/kg b.w.

Executive summary:

The substance has been tested for acute toxicity by oral dose according to the Directive 67/548/EC B.1 ter, class method. A limit test at one dose level of 2000 mg/kg body weight was carried out with six animals. No mortality has been observed until 2000 mg/kg b.w, therefore the LD50 is over than 2000 mg/kg b.w.