Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral:

The oral LD50 value of the test item in Wistar rat was established to exceed 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:
2 000 mg/kg bw
Quality of whole database:
1

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

Oral:

One in vivo test is available in complied with OECD No.423. Test item was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg body weight.

No mortality occurred.

Hunched posture and piloerection were noted for all animals between Days 1 and 4. Abnormal gait was noted for three animals on Day 1.

The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of test item in Wistar rats was established to exceed 2000 mg/kg body weight, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Justification for classification or non-classification

Oral LD50: >2000 mg/kg bw

Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1, this substance should not be classified for this endpoint.

 

Specific target organ toxicity-single exposure:

No significant non-lethal toxic effects observed in acute oral toxicity study.

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1, this substance should not be classified for this endpoint.