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Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
screening for reproductive / developmental toxicity
data waiver
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

For DMPT, exposure based waiving is considered as appropriate since all requirements for exposure based waiving are fulfilled as it will be outlined in the following.

To 3.2.a(i): the results of the exposure assessment for DMPT covering all relevant exposures throughout the life cycle of DMPT demonstrate the absence of significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI section 3.5. The relevant exposures and the lack of significant exposure is laid out in detail in IUCLID section 3.5 and the corresponding sections of the CSR. Further explanation on the background why the exposure is considered to be not significant is given in the following paragraph.

To 3.2.a (ii) a DNEL for DMPT can be derived from results of available test data. There is no exposure to consumers and hence, those DNELs do not need to be calculated. For long-term systemic exposure in Workers, DNELS were calculated based on a 28-day repeated dose toxicity study. Allthough histological changes in the reproductive organs were not observed, there is no information on reproductive performance. Due to the omission of the information requirement for this endpoint., the higher uncertainty was considered using an additional uncertainty factor of 5. This additional factor was used based on the information provided in REACH Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012 (Appendix R.8-12 Reproductive toxicity p 131-135). An additional assessment factor of 2-5 should be considered on a case by case basis where there might be indications for adverse effects on reproductive or developmental toxicity. To 3.2.a (iii) The derived DNELs for DMPT were well below the exposures for humans. This indicates that the risk is well controlled and the exposure can be considered as not significant. Therefore, there is clear evidence that a test will not provide further information for the risk assessment.


Taking into account the argumentation for paragraphs 3.2.a (i-iii) and animal protection reasons exposure based waiving is performed for this endpoint.

Short description of key information:
Exposure Based Waiving was applied.

Justification for selection of Effect on fertility via oral route:
Exposure Based Waiving

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information