Registration Dossier
Registration Dossier
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EC number: 221-717-7 | CAS number: 3209-22-1
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
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
Test material
- Reference substance name:
- 1,2-dichloro-3-nitrobenzene
- EC Number:
- 221-717-7
- EC Name:
- 1,2-dichloro-3-nitrobenzene
- Cas Number:
- 3209-22-1
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 1,2-dichloro-3-nitrobenzene
- Details on test material:
- test substance purity: 99.15%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- admnistration period: male 44 days, females from day 14 before mating to day 3 of lactation.
- Details on mating procedure:
- no data given
- Duration of treatment / exposure:
- admnistration period: male 44 days, females from day 14 before mating to day 3 of lactation; terminal kill: male day 45; females: day 4 of lactation.
- Frequency of treatment:
- daily
- Details on study schedule:
- admnistration period: male 44 days, females from day 14 before mating to day 3 of lactation; terminal kill: male day 45; females: day 4 of lactation.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1, 5, 25, 100 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5 per dose and sex
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects on fertility
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects on offspring
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No adverse effects on fertility and offspring were indicated.
Applicant's summary and conclusion
- Executive summary:
Rats were treated with 1,2-Dichloro-3-nitrobenzene in a Repeated Dose Toxicity study and Reproductive/Developmental Toxicity Screening Test (OECD 422). The rats were treated with 0 (vehicle), 1, 5, 25 or 100 mg/kg bw/day test substance. No adverse effects on reproduction and offspring were indicated. Based on the findings obtained, a NOAEL for fertility and offspring of 100 mg/kg bw/day and is suggested.
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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