Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: EOGRTS without extension of Cohort 1B, without Cohorts 2A and 2B, and without Cohort 3; Justification: see attached document in the field "attached background material" .
Type of information:
experimental study planned
Study period:
2016-2018, depending on ECHA's timeline for permission. Minimum 30 months from Final Desicion
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: to be performed according to Guideline and under GLP.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EOGRTS
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Read-across from the structural analogues TETA (CAS 90640 -67 -8) and HEPA (68121 -73 -7) is proposed. Read-across and intrapolation from these two structural analogues should be sufficient for a proper hazard identification as well as risk assessment

Test animals

Species:
rat
Strain:
other: to be determined
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
plus neutralisation with HCl to pH < 9
Details on exposure:
exposure by gavage to ensure proper dosing, neutralisation to pH < 9 will be required because of the corrosive nature of the substance.
Details on mating procedure:
according to OECD protocol
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
according to OECD protocol
Duration of treatment / exposure:
according to OECD protocol
Frequency of treatment:
according to OECD protocol
Details on study schedule:
according to OECD protocol
No. of animals per sex per dose:
according to OECD protocol

Examinations

Parental animals: Observations and examinations:
according to OECD protocol
Estrous cyclicity (parental animals):
according to OECD protocol
Sperm parameters (parental animals):
according to OECD protocol
Litter observations:
according to OECD protocol
Postmortem examinations (parental animals):
according to OECD protocol
Postmortem examinations (offspring):
according to OECD protocol
Statistics:
to be determined.
Reproductive indices:
according to OECD protocol
Offspring viability indices:
according to OECD protocol

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion