Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
other: study ongoing
Remarks:
study ongoing
Adequacy of study:
key study
Study period:
2020-2021
Reliability:
1 (reliable without restriction)
Justification for type of information:
Following ECHA decision (CCH-D-2114361700-57-01/F) on3-p-cumenyl-2-methylpropionaldehyde, EC No 203-161-7, it was requested to conduct additional toxicological studies:
1. In vitro cytogenicity study in mammalian cells (Annex VIII, Section 8.4.2., test method: OECD TG 473) or in vitro micronucleus study (Annex VIII, Section 8.4.2, test method: OECD TG 487
2. In vitro gene mutation study in mammalian cells (Annex VIII, Section 8.4.3.; test method: OECD TG 476 or TG 490) with the registered substance provided that the study requested under 1. has negative results;
3. Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; test method: EU B.26./OECD TG 408) in rats with the registered substance;
4. Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method: EU B.31./OECD TG 414) in a first species (rat or rabbit), oral route with the registered substance;
5. Extended one-generation reproductive toxicity study (Annex IX, Section 8.7.3.; test method: EU B.56./OECD TG 443) in rats, oral route with the registered substance after providing the OECD 408 outcome.

The OECD 487, OECD 476 and OECD 414 are actually ongoing, the attached contract with the labs justify this fact. The studies will be submitted as soon as available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Remarks:
colorless to pale-yellow liquid
Details on test material:
Batch Number: VE00661246
Expiry date: 29 Aug 2021

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Wistar Han

Administration / exposure

Doses / concentrationsopen allclose all
Dose / conc.:
25 mg/kg bw/day
Dose / conc.:
75 mg/kg bw/day
Dose / conc.:
150 mg/kg bw/day
No. of animals per sex per dose:
22
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
not specified
Description (incidence and severity):
study ongoing
Dermal irritation (if dermal study):
not specified
Description (incidence and severity):
study ongoing
Mortality:
not specified
Description (incidence):
study ongoing
Body weight and weight changes:
not specified
Description (incidence and severity):
study ongoing
Food consumption and compound intake (if feeding study):
not specified
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Details on results:
study ongoing

Maternal developmental toxicity

Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Details on maternal toxic effects:
study ongoing

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Based on:
not specified
Basis for effect level:
other: study ongoing
Remarks on result:
other: study ongoing
Remarks:
study ongoing

Maternal abnormalities

Key result
Abnormalities:
not specified
Localisation:
other: study ongoing

Results (fetuses)

Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Description (incidence and severity):
study ongoing
Details on embryotoxic / teratogenic effects:
study ongoing

Effect levels (fetuses)

Remarks on result:
other: study ongoing
Remarks:
study ongoing

Fetal abnormalities

Abnormalities:
not specified
Localisation:
other: study ongoing
Description (incidence and severity):
study ongoing

Overall developmental toxicity

Key result
Developmental effects observed:
not specified
Treatment related:
not specified

Any other information on results incl. tables

study ongoing

Applicant's summary and conclusion

Conclusions:
study ongoing
Executive summary:

study ongoing