Registration Dossier
Registration Dossier
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EC number: 446-220-4 | CAS number: 365411-50-3
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliability 1 is assigned because the study is conducted according to the respecive OECD guidelines and GLP.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 421
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 446-220-4
- EC Name:
- -
- Cas Number:
- 365411-50-3
- Molecular formula:
- C16 H26 O2
- IUPAC Name:
- 7,7,8,9,9-pentamethyl-2H,4H,4aH,5H,6H,7H,8H,9H,9bH-indeno[4,5-d][1,3]dioxine
- Test material form:
- other: solid
- Details on test material:
- Test material has been applied in food
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- see 7.8.1
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Substance was provided in feed.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- see 7.8.1
- Details on mating procedure:
- see 7.8.1
- Duration of treatment / exposure:
- see 7.8.1
- Frequency of treatment:
- see 7.8.1
- Duration of test:
- see 7.8.1
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
actual ingested
- No. of animals per sex per dose:
- see 7.8.1
- Details on study design:
- see 7.8.1
Examinations
- Maternal examinations:
- see 7.8.1
- Fetal examinations:
- to be filled
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
see 7.8.1
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 121 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 121 mg/kg bw (total dose)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a GLP-compliant reproduction/developmental toxicity screening test, performed according to OECD Guideline 421 no effects were seen up to the highest dose tested (121 mg/kg bw) resulting in the NOAEL.
- Executive summary:
In a GLP-compliant reproduction/developmental toxicity screening test, performed according to OECD Guideline 421, 12
Wistar rats/sex/dose received Nebulone in the diet at concentrations of 0, 15, 50 and 150 mg/kg bw (0, 225, 750 or 1875 mg/kg diet) during a premating period of 2 weeks and during mating (1 week), gestation and lactation until postnatal day 4. Nebulone was h omogeneously distributed in the diets. Feed with Nebulone was freshly prepared every day because in the dose range finding it was shown not to be stable in open container for 4 days. The concentration of Nebulone was close to the intended’ in all diets. No treatment related findings were seen in the dams up to the highest dose considering appearance, general condition or behaviour. No treatment-related effects were observed in mean body weight, body weight changes and food consumption throughout the study. No effects were observed on litter size, pup sex and weight and pup survival. No treatment-related effects of toxicological relevance were observed on macroscopic and microscopic examination. Therefore in dams the highest dose of at least 121 mg/kg bw/day (based on actual intake during gestation and lactation) was a No-Observed-Adverse-Effect Level (NOAEL) for systemic and development toxicity.
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