Registration Dossier
Registration Dossier
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EC number: 939-248-8 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2012 to March 2013
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate nr 2011/40 on July 19th 2011
- Limit test:
- no
Test material
- Reference substance name:
- PROCESS OIL
- IUPAC Name:
- PROCESS OIL
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- For males: - 5 weeks
For females: - 2 weeks before paring, during mating and pregnancy, until day 5 post-partum. - Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg/day 0 mg/mL
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
100 mg/kg/day 20 mg/mL
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
300 mg/kg/day 60 mg/mL
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
1000 mg/kg/day 200 mg/mL
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 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:
- Based on the experimental conditions of the study:
- the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 1000 mg/kg/day
- the No Observed Effect Level (NOEL) for toxic effects on progeny was considered to be 1000 mg/kg/day in the absence of any treatment-related effect on pup viability, clinical signs, body weight and sex ratio up to day 5 post-partum.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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