Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Adequacy of study:
supporting study
Study period:
S
Justification for data waiving:
other:

Data source

Materials and methods

GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
Test material is a member of the Category 1 Rosin and Rosin Salts from the H4R Consortium of which the Registrant is a member. The Consortium has proposed one Two Generation study on the most biologically active member of the category. If that is agreed by ECHA, then to avoid further testing on animals it is proposed to read across from that study rather than to conduct testing on the Registered substance. A read-across (analogous approach) will then be made to Registered substance, since in the stomach Registered substance reverts back to the parent substance which is insoluble in water at stomach pH. See attached hydrolytic stability report in Section 13.

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion