Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]cobaltate(3-)

Endpoint summary

Description of key information

Oral LD50 > 5000 mg/kg bw

Dermal LD50 > 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:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no guideline followed; however, the study meets generally accepted scientific principles and it is acceptable for assessment

Principles of method if other than guideline:

Test method not specified: acute oral toxicity study in male rats by gavage

GLP compliance:

no

Limit test:

yes

Species:

rat

Sex:

male

Vehicle:

DMSO

Details on oral exposure:

1.5 ml per 100 g body weight

Doses:

5000 mg/kg

Details on study design:

gavage

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

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

Conclusions:

LD50 > 5000 mg/kg bw.

Executive summary:

Acute oral toxicity of test substance was assessed in male rats. Test animals were treated by gavage at 5000 mg/kg bw.

LD50 was determined to be > 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

A study report from 1974 was available on the acute toxicity of Acid Brown 303 by oral and dermal route.

Few details on test methods were available. Male rats were tested up to a dose of 5000 mg/kg bw. Oral administration was by gavage; dermal appliaction was on depilated dorsal skin for 4 hours using gauze pads.

LD50 values were found to be > 5000 mg/kg bw for both routes.

Purity of test sample was ca. 50 %; recalculated LD50 values for active ingredient were > ca. 2500 mg/kg bw.

An acute toxicity test by oral route on a structural analogue, i.e. Similar Substance 01, was reported as supporting information. 5 rats/sex were tested at single doses between 1000 and 5000 mg/kg bw. LD50 was identified as 2717 mg/kg, thus confirming results with Acid Brown 303.

By the way, Similar Substance 01 is also not toxic by dermal route, i.e. LD50 > 2000 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), classification for acute toxicity by oral and dermal route is required below the threshold value of 2000 mg/kg bw..

Based on test results, Acid Brown 303 is not classified for acute oral or dermal toxicity.