Reaction mass of sodium 3-[[4-[(4-ethoxy-m-tolyl)azo]-1-naphthyl]azo]benzenesulphonate and sodium 3-[[4-[(4-ethoxyphenyl)azo]-1-naphthyl]azo]benzenesulphonate

Endpoint summary

Description of key information

Oral LD50 (males and females) > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

The read across approach is detailed into the document attached into the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Test item was administered, by oral gavage, to 5 male and 5 female rats at a single dose of 5000 mg/kg bw; substance was dissolved in water at room temperature and given at volume of 30 mg/kg bw. Animals were observed over a period of 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen.
- Age at study initiation: 9 - 14 weeks.
- Weight at study initiation: 173 g
- Housing: Makrolon cage type III, in groups of 5.
- Diet: Altromin R 1324, ad libitum.
- Water: tap water ad libitum.
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1.5 °C
- Relative humidity: 60 ± 5 °C
- Photoperiod: 12 hrs dark / 12 hrs light; artificial illumination from 7 a.m. to 7 p.m.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Substance was dissolved in water at room temperature and given at volume of 30 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day (once on weekends and holidays).

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Clinical signs:

Test item resulted to be relatively non-toxic in the acute test.

Body weight:

Body weight resulted to be unaffected.

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (males and females) > 5000 mg/kg bw

Executive summary:

Test item was administered, by oral gavage, to 5 male and 5 female rats aa a single dose of 5000 mg/kg bw; substance was dissolved in water at room temperature and given at volume of 30 mg/kg bw. Animals were observed over a period of 14 days.

Body weight resulted to be unaffected and the test item resulted to be relatively non-toxic. The LD50 value was indicated to be higher than 5000 mg/kg bw.

Conclusion

LD50 (males and females) > 5000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

There is no data about the oral acute toxicity potential of Acid Orange 127; therefore, the available data on structural analogous Similar Substance 01 has been taken into consideration. The read across approach can be considered as appropriate and suitable to assess the property under investigation (details about the approach are reported into the IUCLID section 13).

The Similar Substance 01 was administered, by oral gavage, to 5 male and 5 female rats aa a single dose of 5000 mg/kg bw; substance was dissolved in water at room temperature and given at volume of 30 mg/kg bw. Animals were observed over a period of 14 days. Body weight resulted to be unaffected and the test item resulted to be relatively non-toxic. The LD50 value was indicated to be higher than 5000 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg bw, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

In conclusion, the test substance does not meet the criteria to be classified for oral acute toxicity, according to the CLP Regulation (EC) No 1272/2008.