Registration Dossier

Administrative data

Description of key information

The acute oral study was performed according to OECD Guideline 423 and GLP principles and the acute dermal study was performed according to OECD Guideline 402 and GLP principles. Based on these studies, Radia 7838 is not considered toxic via oral or dermal route, in acute toxicity tests.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral:

In an acute oral toxicity study, according to OECD, EC, EPA and JMAFF test guidelines, female rats were exposed via gavage to 2000 mg/kg bw of Radiagreen RA. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Hunched posture and piloerection were noted on Day 1 only. Bodyweight gain was considered normal and no abnormalities at macroscopic examination were found. Therefore, the oral LD50 of Radiagreen RA in rats was establised to exceed 2000 mg/kg bw.

Dermal:

In an acute dermal study, performed according to OECD, EC, EPA and JMAFF test guidelines, rats were exposed by a single dermal application to 2000 mg/kg bw of Radiagreen RA for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Piloerection and chromodacryorrhoea were noted, animals recovered between Days 1 and 7. Scales and/or general or maculate erythema were seen in the treated skin-area of the animals during the observation period. Bodyweight gain was considered normal and no abnormalities at macroscopic examination were found. Therefore, the dermal LD50 of Radiagreen RA in rats was establised to exceed 2000 mg/kg bw.

Justification for classification or non-classification

Based on the studies available, Radiagreen RA is not classified for acute toxicity according to CLP Regulation (EC) No. 1272/2008 and EC Directive 67/548/EEC.