Registration Dossier

Administrative data

developmental toxicity
Study period:
The study period depends on the availability of the ECHA decision on this testing proposal. The study will be conducted after approval of the testing proposal.
Data waiving:
study waived due to provisions of other regulation
Justification for data waiving:
Justification for type of information:
The main substance use is in consumer cosmetic products. According to the EU cosmetics regulation 1223/2009, performing an animal study with a cosmetic ingredient may trigger a marketing ban within the EU of cosmetic products containing this ingredient. Since the substance is a fragrance raw material, it will be contained in a vast number of cosmetic products of virtually all cosmetic product manufacturers. Thus performing additional animal studies with the substance carries a disproportionate economic financial risk, which involves not only using the customers and, therefore, the business with the substance that today supports the tonnage band update, but also may cause financial compensation claims orders of magnitude higher than the turnover with the substance itself. Therefore, currently no additional animal study can be performed and the risk assessment will continue to be based on the fertility and reproductive NOAEL derived from the OECD 422 study. The results of the OECD 422 study do not indicate that by doing so a relevant risk for workers or consumers goes uncontrolled.

Data source

Materials and methods

Test guideline
according to guideline
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of (2R*,4R*,4aR*,9bS*)-2,4-dimethyl-4,4a,5,9b-tetrahydroindeno[1,2-d][1,3]dioxine and (2R*,4R*,4aS*,9bR*)-2,4-dimethyl-4,4a,5,9b-tetrahydroindeno[1,2-d][1,3]dioxine
EC Number:
Molecular formula:
Reaction mass of (2R*,4R*,4aR*,9bS*)-2,4-dimethyl-4,4a,5,9b-tetrahydroindeno[1,2-d][1,3]dioxine and (2R*,4R*,4aS*,9bR*)-2,4-dimethyl-4,4a,5,9b-tetrahydroindeno[1,2-d][1,3]dioxine

Test animals

other: rat or rabbit

Results and discussion

Applicant's summary and conclusion