Registration Dossier
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EC number: 220-168-0 | CAS number: 2650-18-2
Endpoint summary
Administrative data
Description of key information
LC50 > 1900 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 1 900 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
Additional information
The following reported data were obtained for Similar Substance 1. It is expected that the Target substance will present similar effect levels of acute toxicity. Justification for Read Across is given in Section 13 of IUCLID.
Similar Substance 1 has been used as a colorant for long time and the oldest studies date back to the 1960ies. Accordingly, a number of non-standard studies with limited documentation are available. The overall data shows that the substance is of low acute toxicity.
A high quality study for acute oral toxicity in rats is available with an aqueous formulation containing 38% of the colorant.
The formulation was applied by gavage. The study was not performed under GLP, but it is reported in sufficient detail to be acceptable. The procedures provided in OECD testing guideline 423 were followed. The doses of the formulation were up to 5000 mg/kg bw, so high that for the substance itself, the highest dose was calculated to be 1900 mg/kg bw. This is slightly lower than the limit dose of 2000 mg/kg bw as defined in the OECD testing guideline. Nevertheless, this value is not classifing the substance for acute toxicity since other supporting studies reports LD50 > 2000 mg/kg bw. Furthermore, the only effect observed was the turquoise coloration of the urine which indicates that the blue colorant is at least partly taken up by the body and eliminated via the kidneys. It is highly unlikely that an LD50 would be lower than 2000 mg/kg bw. In addition, older literature publications with limited details indicate that the LD50 in rats after gavage or intraperitoneal dosing is greater than 2000 mg/kg bw (Lu 1964). Also absence of acute oral toxicity observed in a range-finding study for a comet assay in mice is supportive of overall low acute toxicity (Sasaki 2002). The latter study has the major limitation that the post-observation period was probably only 24hours and certainly not two weeks.
Assessment of acute dermal toxicity:
Toxicokinetic data for Similar substance 1 for the oral route showed that only ca 2% of the substance is absorbed. A very low absorption can also be assumed for the dermal route because the log Pow is negative and the molecular weight is greater than 500 g/mol. The substance is not affected by the acidic pH of the stomach. In accordance with ECHA guidance, the dermal route does not need to be tested for substances causing no toxicity at the oral route at the limit dose.
No experimental data are available for Similar Substance 1 for the inhalation route.
Assessment for acute toxicity: other routes.
Poorly documented data on intraperitoneal injection are also reported to support the evaluation of Acute toxicity for Similar Substance 1. A dose of 4600 mg/kg bw has been subcutaneously administered to mice. No mortality occurred. This result confirms that the substance is of not toxic.
References:
- Lu, F.C. et al. The Acute Toxicity of Some Synthetic Colours Used in Drugs and Foods.Can. Pharm. J.97: 30.
- Sasaki et al. 2002. The comet assay with 8 mouse organs: results with 39 currently used food additives.Mutation Research.519: 103-119.
Justification for classification or non-classification
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), Part 3: Health Hazards, the substances can be classified for acute toxicity when the following criteria are met:
Category 1: 0 < LD50 <= 5
Category 2: 5 < LD50 <= 50
Category 3: 50 < LD50 <= 300
Category 4: 300 < LD50 <= 2000
Based on the available data the LD50 is expected to be greater than 2000 mg/kg bw. Terefore, the classification for acute toxicity is not justified, according to the CLP Regulation (EC 1272/2008).
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