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Registration Dossier
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EC number: 225-918-0 | CAS number: 5146-66-7
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Subacute(repeated dose study)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from Commission of the European Communities
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Commission of the European Communities DG XI
- Author:
- Prepared by-Germany
- Year:
- 2 007
- Bibliographic source:
- CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES Recommended form to be used for the proposed classification and labelling of a dangerous substance under Directive 67/548/EEC, January 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 407 and was performed under GLP conditions
- Principles of method if other than guideline:
- Repeated dose orral toxicity study of 3,7-Dimethylocta-2,6-dienenitrile in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3,7-dimethylocta-2,6-dienenitrile
- EC Number:
- 225-918-0
- EC Name:
- 3,7-dimethylocta-2,6-dienenitrile
- Cas Number:
- 5146-66-7
- Molecular formula:
- C10H15N
- IUPAC Name:
- 3,7-dimethylocta-2,6-dienenitrile
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): 3,7-dimethylocta-2,6-dienenitrile
- Molecular formula (if other than submission substance): C10H15N
- Molecular weight (if other than submission substance): 149.236 g/mole
- Smiles notation (if other than submission substance): N#C\C=C(\CC\C=C(\C)C)C
- InChl (if other than submission substance): 1S/C10H15N/c1-9(2)5-4-6-10(3)7-8-11/h5,7H,4,6H2,1-3H3/b10-7+
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- olive oil
- Details on exposure:
- No data available
- Details on mating procedure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
- Details on study schedule:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 150 and 450 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- Total: 60
0 mg/kg bw:10 male, 10 female
50 mg/kg bw: 5 male, 5 female
150 mg/kg bw: 5 male, 5 female
450 mg/kg bw:10 male, 10 female - Control animals:
- not specified
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- No data available
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Reproductive organ weight and histopathology were examined.
- Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P0)
Organ weights : No statistically significant differences in absolute or relative weights of testes, epididymides or ovaries were observed as compared to control, except for increased relative testes and epididymides weights in 450 mg/kg bw males. The absolute organ weights were unchanged but the body weights of 450 mg/kg bw dose group were clearly decreased thus leading to a calculated increase in the relative weights of testes and epididymides thus, the calculated organ weight differences can be regarded as to be artefacts. Repeated dose study data do thus not indicate any potential of geranylnitrile to impair fertility.
Histopathology: Histopathology did not detect any corresponding or other substance-related effects on gonads
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 450 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on reproductive organ weight, grosspathology and Histopathology
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P1)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Effect levels (F1)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to 450 mg/kg bw when Wistar male and female rats were treated with 3,7-Dimethylocta-2,6-dienenitrile orally by gavage in olive oil for 24 days.
- Executive summary:
In a repeated dose oral toxicity study, Wistar male and female rats were treated with 3,7-Dimethylocta-2,6-dienenitrile in the concentration of 0, 50, 150 and 450 mg/kg bw orally by gavage in olive oil. Decrease in body weight was observed in 450 mg/kg bw treated male rats. No statistically significant differences in absolute or relative weights of testes, epididymides or ovaries were observed as compared to control, except for increased relative testes and epididymides weights in 450 mg/kg bw males. The absolute organ weights were unchanged but the body weights of 450 mg/kg bw dose group were clearly decreased thus leading to a calculated increase in the relative weights of testes and epididymides thus, the calculated organ weight differences can be regarded as to be artefacts. Repeated dose study data do thus not indicate any potential of geranylnitrile to impair fertility. In addition, no histopathological changes were observed in reproductive organ of treated male and female rats as compared to control. Therefore, NOAEL was considered to 450 mg/kg bw when Wistar male and female rats were treated with 3,7-Dimethylocta-2,6-dienenitrile orally by gavage in olive oil for 24 days.
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