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Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No studies are available with regard to reproduction and developmental toxicity of e-caprolactone. However, a well conducted 90-day inhalation study showed no macroscopic and histopathological effects on reproductive organs and also other systemic effects were not found during this study. The lack of systemic effects can be explained by the rapid hydrolysis in stomach and blood, resulting in the formation of 6-hydroxyhexanoic acid. No reproductive toxicity is expected for this simple aliphatic carboxylic acid.

Short description of key information:
Reproductive toxicity is not predicted based on an absence of effects in a 90-day inhalation study, the rapid hydrolysis of e-caprolactone under physiological conditions and the low predicted toxicity of the hydrolysis product.

Effects on developmental toxicity

Description of key information
A rabbit developmental toxicity study performed with the read-across substance adipic acid reports a NOAEL for maternal and developmental toxicity of 250 mg/kg bwd, the highest dose level tested.
Effect on developmental toxicity: via oral route
Dose descriptor:
250 mg/kg bw/day
Additional information

Rabbits were artificially inseminated on day 0, adipic acid (in water) was administered by gavage on gesatational days 6 through 18 at doses of 0, 2.5, 12, 54 and 250 mg/kg (FDA, 1974). A read-across is proposed because adipic acid is structurally similar to e-Caprolactone, and the toxic effects on the developing foetus would be the same. On day 29 all does were subject to Caesarean section for examination of urogenital tract and foetal examination. No maternal toxicity was observed. There was no effect on maternal survival. There was no effect on nidation or on foetal survival. The number of abnormalities seen in either soft or skeletal tissue of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. No differences between controls and treated groups were found for corpora lutea, implantations, total number of resorptions, total number of foetuses, total number of live litters and foetal weights. The NOAEL for both maternal and developmental toxicity was 250 mg/kg bw/d.

Justification for classification or non-classification

There is no indication of an effect on fertility or reproduction from the results of a 90 -day inhaltion toxicity study. e-caprolactone is rapidly hydrolysed under physiological conditions and the hydrolysis prodcut is considered unlikley to be a reproductive toxin. There was no evidence of developmental toxicity in a rabbit study performed with the read-across substance adipic acid. The available data do not therefore indicate that the substance requires classification for reproductive or developmental toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (the CLP Regulation).