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Toxicological information

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Description of key information

Rat oral LD50 > 5000 mg/kg bw

Rat inhalation LC50 > 1895 mg/m3

Rat dermal LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

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 adverse effect observed
Dose descriptor:
LC50
Value:
1 895 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

No specific tests on the substance under registration were performed, but it is part of the Stilbene Fluorescent Whitening Agents category. Within the whole category ten over fourteen registered substances were tested and none of the existing tests arisen any concern for acute oral toxicity.

All substances of the category are big ionic molecules, generally not absorbed and quickly excreted with no effect.

The substance belongs to the group 1 of the category, in which the substitution on the triazino moiety is a diethylamine. The group is the least reactive between all the other functional groups of the category, both from a chemical and from a metabolic point of view. The most similar substances is the analogous diethylaminoderivative, less sulfonated, 1 -MSA; the dihydroxyethylamino derivatives, di- and tetrasulphonated (1 -DSA, 3a-A(NaK) and 3a-MSA) are respectively less and more water soluble; therefore, the result of acute toxicity can be interpolated on the basis of water solubility, Kow and specific functional group reactivity, between the results of those substances.

Skin adsorption has been evaluated and calculated for all members of the category (see Category Justification Report attached to the Section 13).

As it can be noted, the influence of the variability in functional groups is very low, more related to the variability in the polarity of the substance than in the potential reactivity that can arise a concern. From a metabolic point of view, an estimation was performed in order to verify if breakdown products may be formed by the dermal metabolism, using the OECD Toolbox.

Seven registered substances belonging to the category were tested for acute dermal toxicity and they represent several groups/subgroups: the results indicated a LD50 > 2000 mg/kg bw (the highest tested dose) for all members. A good GLP Klimish 1 study on CAS 16470-24-9 was chosen as representative and was here reported for acute dermal toxicity (Ciba-Geigy Ltd., 1991): it was performed at 2000 mg/Kg bw with no effect.

Because of the physical state and the trade forms, inhalation is not an appropriate route of exposure. Acute toxicity results for the other two exposure routes indicate no concern therefore no testing was performed.

One test is available on an analogous substance, performed at the maximum allowed concentration of 1890 mg/m3: no effects were observed.

In conclusion, it can be stated that the substance is not acutely toxic for all the three exposure ways.

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 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 5000 mg/kg body weight, 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).

The dermal LD50 value was established to exceed 2000 mg/kg body weight, which exceeded the highest CLP classification limit (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).

 

The inhalation LC50 value was established to be greater than 1895 mg/m3. For powder the limit for classification is ATE > 5 mg/l (i.e. 5000 mg/m3). Since no effect was observed at the tested concentration and this was the maximum reachable concentration in the test condition, it is assumed that the substance is not classified for inhalation acute toxicity.

 

In conclusion, the available experimental data are adequate for classification and labelling and the test substance is non classified for oral/ dermal/inhalation acute toxicity, according to the CLP Regulation (EC 1272/2008).