Cobaltate(3-), bis[6-amino-5-[(2-hydroxy-3,5-dinitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, sodium

Endpoint summary

Description of key information

LD50 in rats > 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 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 study available

Additional information

The overall assessment on acute toxicity was based on available data on Acid Green 104, Similar Substance 01 and Similar Substance 02.

In particular, Acid Green 104 and read-across substances are cobalt complexes with 2 phenyl-azo-naphtyl ligands functionalised by similar groups. Details on the read across process are attached in section 13.

For rats exposed to test substances, LD50 values were calculated. In all cases, LD50 values were above 2000 mg/kg bw.

In an acute oral toxicity study (OECD Guideline 423), 6 rats were dosed with 2000 mg/kg bw of Similar Substance 01 by gavage. No mortality was recorded in any of the test group, thus LD50 > 2000 mg/kg bw.

Further studies by oral route on Similar Substance 02, tested in different compositions, were available and confirmed the lack of acute toxicity. Available LD50 values are reported in the table below.

FAT	% dye	LD50	date
FAT 20036/A	42%	18320	1974
FAT 20036/B	75%	> 7750	1978
FAT 20036/C	63%	> 5000	1980
FAT 20036/D	71.8%	> 5000	1982

Available information indicated each FAT as composed by dye and coupage, typically sodium lignosulfonate, water, sodium sulfate. Such species were expected to have no impact on the toxicological profile.

In addition, Acid Green 104 was tested in rats, via oral and inhalation route, and in mice, via intraperitoneal route, respectively.

Oral exposure led to a LD50 > 5000 mg/kg bw; upon inhalation, no deaths were reported; intraperitoneal exposure led to a LD50 between 200 and 700 mg/kg. However, due to the lack of details, in terms of tested doses and/or number of animals, the relevance of such results could not be assessed.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by 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).

All LD50 values by oral route were established to be greater than 2000 mg/kg body weight, i.e. above the classification threshold for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

In conclusion, the test substance was not classified for acute oral toxicity, according to the CLP Regulation (EC 1272/2008).