Registration Dossier
Registration Dossier
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EC number: 946-752-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50 value > 2000 mg/kg bw for the pure substance (extrapolation based on results with mixture)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- 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
No information on "acute oral toxicity" of the Target Substance is available. However data on a similar substance (Similar Substance 01) has been taken into account for the assessment. More details on the substance similarity are reported in section 13.
An acute oral toxicity study (key study) was perfomed by using Sprague-Drawley strain rats. Based on the results of the range-finding study, the test substance (49 % act. integr.) was administered by gavage to 5 animals per 5 sex in doses of 2000 mg/kg bw. The animals were observed for mortality and signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. The results indicated no deaths. No signs of systemic toxicity were noted during the study. Dark red staining of the fur was noted in all males from the 1 -hour observation to the day 1 observation, and in one female at the 4 -hour and 1 day observations. Individual bodyweights were recorded prior to dosing on Day 0 and on Day 7 and 14. All animals showed expected gain in bodyweight during the study. No abnormalities were noted necropsy. The acute oral LD50 of the test material in rats was found to be greater than 2000 mg/kg bw. Since no deaths, no signs of systemic toxicity, normal bw gain, no abnormalities at necropsy were observed in the oral acute toxicity key study with the 49 % mixture, the LD50 for the pure substance is also expected to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
Based on the criteria defined by the EU and the CLP criteria, the test substance needs not to be labelled for acute oral toxicity because no death occurred in the highest dosing group of 2000 mg/kg bw that could be attributed to the test substance administration.
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