Registration Dossier
Registration Dossier
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EC number: 210-848-5 | CAS number: 624-48-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD 421 dd 2 October 2013, under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 624-48-5
- IUPAC Name:
- 624-48-5
- Reference substance name:
- Dimethyl maleate
- EC Number:
- 210-848-5
- EC Name:
- Dimethyl maleate
- Cas Number:
- 624-48-6
- Molecular formula:
- C6H8O4
- IUPAC Name:
- dimethyl (Z)-but-2-enedioate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- see 7.8.1 Toxicity to reproduction
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- see 7.8.1 Toxicity to reproduction
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- see 7.8.1 Toxicity to reproduction
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- see 7.8.1 Toxicity to reproduction
- Duration of treatment / exposure:
- First Test Item Adminismtration: Day 1 of pre-pairing
Pre-Pairing: 14 days
Pairing: 14 days maiximum
Gestation: Approx. 21 days
Treatment ends: females: on day 3 post partum; males: on day before sacrifice
Necropsy: females: on day 4 post partum; males: After a minimum of 28 days treatment. - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Exposure groups: 0, 50, 200 and 400 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- per dose group: 12 males and 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- see 7.8.1 Toxicity to reproduction
Examinations
- Observations and examinations performed and frequency:
- see 7.8.1 Toxicity to reproduction
- Sacrifice and pathology:
- see 7.8.1 Toxicity to reproduction
- Other examinations:
- see 7.8.1 Toxicity to reproduction
- Statistics:
- see 7.8.1 Toxicity to reproduction
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL (No Observed Effect Level) for general toxicity in males and females was considered to be below 50 mg/kg/day, but the NOAEL (No Observed Adverse Effect Level) for general toxicity in males and females was considered to be 200 mg/kg/day.
The NOEL (No Observed Effect Level) and the NOAEL (No Observed Adverse Effect Level) for reproduction/developmental toxicity was considered to be 200 mg/kg/day. - Executive summary:
see 7.8.1 Toxicity to reproduction
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