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Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key information:
The potential reproductive toxicity of FLL Samples 3 and 4 has been studied using a test of the combined short-term repeated dose toxicity and screening for reproductive/developmental toxicity. For both samples, there were no treatment related effects on sexual function and fertility or development of the offspring (maximum dose = 1000 mg/kg bw/d). This evidence indicates that the FLL Substances should not be classified for reproductive toxicity. A NOAEL of 1000 mg/kg bw/d was used as the starting point for all of the repeated dose DNELs developed in the preceding sections and, therefore, these DNELs would also be protective for possible reproductive effects.

Effects on developmental toxicity

Description of key information
The potential reproductive toxicity of FLL Samples 3 and 4 has been studied using a test of the combined short-term repeated dose toxicity and screening for reproductive/developmental toxicity. For both samples, there were no treatment related effects on sexual function and fertility or development of the offspring (maximum dose = 1000 mg/kg bw/d). This evidence indicates that the FLL Substances should not be classified for reproductive toxicity. A NOAEL of 1000 mg/kg bw/d was used as the starting point for all of the repeated dose DNELs developed in the preceding sections and, therefore, these DNELs would also be protective for possible reproductive effects. 

Justification for classification or non-classification

The potential reproductive toxicity of FLL Samples 3 and 4 has been studied using a test of the combined short-term repeated dose toxicity and screening for reproductive/developmental toxicity. For both samples, there were no treatment related effects on sexual function and fertility or development of the offspring (maximum dose = 1000 mg/kg bw/d). This evidence indicates that the FLL Substances should not be classified for reproductive toxicity.

Additional information