Reaction product of diazotised 4-amino-5-hydroxy-2,7- naphthalenedisulfonic acid coupled with resorcinol, subsequently coupled with diazotised 2-amino-4,6-dinitrophenol and 4-nitrobenzenamine, chelated with iron (3+), sodium salts

Endpoint summary

Description of key information

LD50 > 2000 mg/kg b.w.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

other: Royal Decree 363/1995

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

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.

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

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

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.

Interpretation of results:

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

Conclusions:

The substance was tested for acute oral toxicity following EU MEthod B.1 tris. Under the experimental conditions the LD50 > 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.

Conclusion

LD50 > 2000 mg/kg b.w.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral exposure:

The study was conducted according to the method described into the Directive EC n. 67/548 Annex IV B. B.1 .ter.

The substance has been tested for acute oral administration by gavage. Six rats (3 males and 3 females) were used for the study at concentration of 2000 mg/kg bw.

No clinical symptoms were recorded and no deaths occurred. During autopsy no macroscopic changes were seen.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

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

The LD50 of the test substance was determined to be > 2000 mg/kg bw which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure