Registration Dossier
Registration Dossier
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EC number: 274-407-9 | CAS number: 70210-10-5
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity in rats by gavage.
LD50 = 636.3 mg/kg bw as active ingredient.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 636.3 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
An acute oral toxicity on rats (1994) was selected as key study. The composition of test substance was: 45 % dye and 55 % sodium lignosulphonate as dispersing agent. The parameters observed at periodic intervals up to day 14 were mortality, clinical signs, body weights and macroscopic findings after necropsy at day 14.
No clinical signs of systemic toxicity were seen during the study. Post mortem necropsy showed no abnormalities in survived animals, whereas abnormalities on lungs, kidneys, liver, intestines, stomach...were noted in animals dead during the study period.
Taking into account the 45 % purity of test material, a LD50 value of 636.3 mg/kg bw, as active ingredient, was obtained.
An acute oral toxicity study (1981) was disregarded, due to the type of dispersing agent. It is described as cresol-formaldehyde-naphtalenesulphonate condensate, i.e. a synthetic dispersing agent. Synthetic dispersants were used until sodium lignosulphonate displaced them, due to its lower toxicity. The higher acute toxicity in this study, despite the lower concentration of active ingredient of ca. 30 % with respect to ca. 45 % of the key study, may be attributed to the type of dispersant and not to the nature of the active ingredient itself.
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 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 study in rats, an oral LD50 value of 636.3 mg/kg bw was found; a LD50 of 299.4 mg/kg was disregared due to the composition of the test material, which contains ca. 70 % of cresol-formaldehyde-naphtalenesulphonate condensate as dispersant. Such dispersant is expected to contribute to the toxicity of the test material.
Accordingly, the test substance was classified for acute oral toxicity in category 4 (LD50 between 300 and 2000 mg/kg bw) in the CLP Regulation (EC 1272/2008).
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