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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information

No effects on reproductive organs were found in the 90-day OECD 408 study summarized elsewhere in this dossier. In addition, there were no developmental effects reported in an OECD TG 414 study.These results suggest a low risk for reproductive toxicity; therefore, we are waiving the requirement for a reproductive toxicity study.


 


Justification for selection of Effect on fertility via oral route:


A reproduction study is scientifically unjustified based on the lack of adverse findings on reproductive organs in a 90-day repeat dose study as well as in a developmental study.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Quality of whole database:
No effects on reproductive organs were found in the 90-day OECD TG 408 study summarized elsewhere in this dossier. In addition, there were no developmental effects reported in an OECD TG 414 study. These results suggest a low risk for reproductive toxicity; therefore, we are waiving the requirement for a reproductive toxicity study.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

No adverse developmental findings were reported in an OECD 414 study when tested up to 300 mg/kg/day.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Treatment of pregnant females with Di-Tert-Butyl 1,1,4,4-Tetramethyl Tetramethylene Diperoxide (CAS# 78-63-7) at dosages of up to 300 mg/kg bw/day was not associated with any obvious treatment-related effects on clinical signs, body weight performance or food consumption. As anticipated, necropsy revealed an increased in absolute and body weight relative liver weights but there were no obvious macroscopic abnormalities apparent. Increased liver weights were also apparent for both sexes at 150 mg/kg bw/day in a Ninety Day Toxicity Study in the Rat (Harlan Laboratories Ltd Study Number 41301877) with this test item; this finding was not accompanied by any evidence of microscopic change and was considered to be adaptive in nature. The increased liver weights at 300 mg/kg bw/day are considered most likely to reflect the same adaptive process and, as such, are considered not to represent an adverse effect of treatment. A dosage of 300 mg/kg bw/day is therefore considered to represent the No Observed Adverse Effect Level (NOAEL) for the pregnant females with the No Observed Effect Level (NOEL) being 60 mg/kg bw/day.   The No Observed Effect Level (NOEL) for the in-utero survival, growth and development of the offspring was considered to be 300 mg/kg bw/day.

Justification for selection of Effect on developmental toxicity: via oral route:

Apparently well conducted study GLP.

Justification for classification or non-classification

There were no adverse effects, on reproductive organs, in a 90-day repeat dose study and no adverse developmental effects reported in an OECD 414 study.

Additional information