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

Endpoint summary

Description of key information

LD50 > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test: single oral administration
- Observation period: 7 days
- Parameters analysed / observed: mortality

GLP compliance:

no

Remarks:

Pre 1981

Species:

rat

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

- Concentration in vehicle: 3 to 35 % suspension in 0.5 % CMC solution.

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: Dyspnea, feces blackened, some animals showed diarrhea and slight apathy.

Gross pathology:

No abnormalities detected.

Interpretation of results:

other: CLP Criteria not met

Conclusions:

LD50 > 10000 mg/kg b.w.

Executive summary:

Rats were exposed to a single oral dose of the test item, which followed a period of observation of 7 days.

No mortality was recorded; no significant clinical signs or organ abnormalities were recorded.

Conclusion

LD50 > 10000 mg/kg b.w.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

November 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

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:

other: 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:

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

No studies on "Acute toxicity" are available for the Target Substance, therefore information on Similar Substances 01 and 02 have been taken into account for the assessment. Details on the similarity between the Target Substance and the Similar Substances are reported in section 13.

 

Acute toxicity was assessed through oral, dermal, inhalation and intraperitoneal route of exposure.

 

Acute toxicity: oral

Two studies were considered in order to complete the assessment on Acute oral toxicity: the first test was conducted on Similar Substance 01 but limited information are available regarding the method and the experimental results. Therefore, another test conducted on the Similar Substance 02 was considered in order to confirm the results of the first test.

The two results are consistent (LD50 > 10000 mg/kg bw and LD50 > 2000 mg/kg bw) and the substance is expected to have an LD50 > 2000 mg/kg bw.

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