Reaction mass of Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)Vinyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)]-, sodium and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[2-(sulfooxy)Ethanol]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt

Endpoint summary

Description of key information

Available studies in rats:

LD50 > 5000 mg/kg, LD10 = 5000 mg/kg = 1800 mg/kg as active ingredient.

LD50 > 2000 mg/kg, LD0 = 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Reliable and well-conducted studies.

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 acute toxicity data was available on test substance. Therefore, available studies on RA Substance 01 and RA Substance 02 were used for the assessment.

In particular, RA Substance 01 is a copper complex and shares most of its structure with target substance (all 3 constituents) except for a small portion, which may possibly be released upon cleavage of an azo bond. RA Substance 02 was used to account for possible effects caused by this portion, based on its structural similarity.

A detailed description of the read across approach is attached in section 13.

As for RA Substance 01, in the first study (1983), 5 rats/sex were exposed by oral gavage to a single dose of 5000 mg/kg bw and observed for up to 14 days, according to OECD guideline 401. One mortality was reported, thus this dose was interpreted as LD10.

In the second study (2009), 5 female rats were used and no mortalities were reported at the tested dose of 2000 mg/kg bw, according to OECD guideline 420. In addition, no signs of systemic toxicity and changes in bodyweights were noted. Accordingly, a LD50 above 2000 mg/kg was established.

In order to complete the assessment, data on RA Substance 02 was taken into account. In particular, in two genotoxicity studies, no mortality was noted up to the highest tested dose in mice, namely 2000 mg/kg bw and 1000 mg/kg bw administered twice, 24 hour far.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as LD50 (oral, dermal) or LC50 (inhalation) values as well as acute toxicity estimates (ATE).

In the available studies on RA Substance 01, oral LD50 values were not identified as 1/10 rats and 0/5 rats were found dead during the 14 -day observation period upon exposure to single doses of 5000 mg/kg and 2000 mg/kg, respectively.

Similarly, no LD50 could be identified in mice as no animal was found dead after 1000 mg/kg administered twice in 24 hours to 7 mice or 2000 mg/kg administered as single dose to 4 mice.

Based on LD50 values above the threshold of classification for acute toxicity by oral route set in the CLP Regulation (EC 1272/2008), i.e. 2000 mg/kg, RA Substance 01 was not classified.

Moreover, even though RA Substance 02 was tested for genotoxicity, no evidence of acute toxicity was noted at the highest tested doses in mice, i.e. 1000 mg/kg and 2000 mg/kg.

In conclusion, a classification for acute toxicity under the CLP Regulation was not applied to target substance.