Registration Dossier
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EC number: 203-161-7 | CAS number: 103-95-7
Toxicological information
Developmental toxicity / teratogenicity
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:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-p-cumenyl-2-methylpropionaldehyde
- EC Number:
- 203-161-7
- EC Name:
- 3-p-cumenyl-2-methylpropionaldehyde
- Cas Number:
- 103-95-7
- Molecular formula:
- C13H18O
- IUPAC Name:
- 2-methyl-3-[4-(propan-2-yl)phenyl]propanal
- Test material form:
- liquid
- Remarks:
- colorless to pale-yellow liquid
- Details on test material:
- Batch Number: VE00661246
Expiry date: 29 Aug 2021
Constituent 1
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
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