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EC number: 204-541-5 | CAS number: 122-40-7
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- HUMAN HEALTH TIER II ASSESSMENT FOR Amyl and hexyl cinnamaldehyde
- Author:
- NICNAS
- Year:
- 2 017
- Bibliographic source:
- INVENTORY MULTITIERED ASSESSMENT AND PRIORITISATION (IMAP) NICNAS
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- The study was designed to investigate the reproductive toxicity effects of α-hexylcinnamaldehyde in rats by the oral route.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- 2-benzylideneoctanal
- Cas Number:
- 101-86-0
- Molecular formula:
- C15H20O
- IUPAC Name:
- 2-benzylideneoctanal
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): α-hexylcinnamaldehyde
- Molecular formula :C15H20O
- Molecular weight :216.322 g/mole
- Substance type: organic
- Physical state: liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): α-hexylcinnamaldehyde
- Molecular formula :C15H20O
- Molecular weight :216.322 g/mole
- Substance type: organic
- Physical state: liquid
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test material mixed with corn oil
DIET PREPARATION
- Rate of preparation of diet (frequency):No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food:No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Test material soluble in corn oil
- Concentration in vehicle: 12.5, 25, 50 or 1000 mg/kg bw.
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity:No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Premating exposure period: 14 days
Total exposure period: males 46 days , females 44 days
The males received the treatment for 14 days before cohabitation,through mating for a maximum of seven days and were euthanised on the day 47 of treatment.
Female rats were treated two weeks before cohabitation, through mating and were euthanised on day 45 of treatment. - Frequency of treatment:
- No data available
- Details on study schedule:
- Terminal killing: males on day 47; females on day 45 of treatment.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 12.5 mg/kg bw/day
- Dose / conc.:
- 25 mg/kg bw/day
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- Total:80
0 mg/kg bw/day: 8 male and 8 female
12.5 mg/kg bw/day:8 male and 8 female
25.0 mg/kg bw/day:8 male and 8 female
50.0mg/kg bw/day:8 male and 8 female
1000.0mg/kg bw/day:8 male and 8 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Oestrous cyclicity (parental animals):
- Estrous cyclicity was examined
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: [yes/no]
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:Clinical observeation was performed
[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, anogenital distance (AGD), presence of nipples/areolae in male pups, other:]
GROSS EXAMINATION OF DEAD PUPS: yes
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY:No data available
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY:No data available - Postmortem examinations (parental animals):
- GROSS NECROPSY: Yes
HISTOPATHOLOGY / ORGAN WEIGHTS : Yes - Postmortem examinations (offspring):
- The first group of offspring (FI) generation pups were euthanised on fifth day of lactation.
- 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:
- no effects observed
- Description (incidence and severity):
- No treatment related clinical observations were seen in the parent (P) generation of either sex.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights were unaffected in male rats.In treated P generation female rats, the body weights or body weight gains were not affected by the treatment during the pre cohabitation and the gestation periods. A significant decrease in maternal body weight in the 1000 mg/kg bw/day dose group was reported during the lactation period and was considered as the maximum tolerated dose (MTD).
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Feed consumption were unaffected in male rats.
In treated P generation female rats, the feed consumption were not affected by the treatment during the pre cohabitation and the gestation periods. - 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
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No treatment related effect was seen on oestrous cycling at any tested dose.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No treatment related effect was seen on mating and fertility at any tested dose.
Details on results (P0)
No treatment related clinical observations or gross lesions were seen in the parent (P) generation of either sex.
Body weights and feed consumption were unaffected in male rats. In treated P generation female rats, the body weights or body weight gains and the feed consumption were not affected by the treatment during the precohabitation and the gestation periods. A significant decrease in maternal body weight in the 1000 mg/kg bw/day dose group was reported during the lactation period and was considered as the maximum tolerated dose (MTD). No treatment related effect was seen on oestrous cycling, mating and fertility at any tested dose.
Body weights and feed consumption were unaffected in male rats. In treated P generation female rats, the body weights or body weight gains and the feed consumption were not affected by the treatment during the precohabitation and the gestation periods. A significant decrease in maternal body weight in the 1000 mg/kg bw/day dose group was reported during the lactation period and was considered as the maximum tolerated dose (MTD). No treatment related effect was seen on oestrous cycling, mating and fertility at any tested dose.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- body weight and weight gain
- food consumption and compound intake
- reproductive function (oestrous cycle)
- reproductive performance
- other: No treatment related effect was seen.
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
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
Effect levels (P1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related clinical effects were seen in the F1 generation pups.
- 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:
- no effects observed
- Description (incidence and severity):
- No treatment related necropsy effects were seen in the F1 generation pups.
- 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)
No treatment related clinical or necropsy effects were seen in the F1 generation pups and no developmental effects were observed.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No developmental effects were observed.
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- 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 (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for maternal and developmental toxicity was considered to be >=1000 mg/kg bw/day. When rats were treated with α-hexylcinnamaldehyde (CAS No.-101-86-0) orally.
- Executive summary:
In a one generation study conducted similarly to OECD TG 421, Crj: CD (SD) rats (eight animals/sex/dose) were fed α-hexylcinnamaldehyde (CAS No.-101-86-0) in corn oil at 12.5, 25, 50 or 1000 mg/kg bw. The males received the treatment for 14 days before cohabitation,through mating for a maximum of seven days and were euthanised on the day 47 of treatment. Female rats were treated two weeks before cohabitation, through mating and were euthanised on day 45 of treatment. The first group of offspring (FI) generation pups were euthanised on fifth day of lactation. No treatment related clinical observations or gross lesions were seen in the parent (P) generation of either sex. Body weights and feed consumption were unaffected in male rats. In treated P generation female rats, the body weights or body weight gains and the feed consumption were not affected by the treatment during the pre cohabitation and the gestation periods. A significant decrease in maternal body weight in the 1000 mg/kg bw/day dose group was reported during the lactation period and was considered as the maximum tolerated dose (MTD). No treatment related effect was seen on oestrous cycling, mating and fertility at any tested dose. No treatment related clinical or necropsy effects were seen in the F1 generation pups and no developmental effects were observed. Hence The NOAEL for maternal and developmental toxicity was considered to be >=1000 mg/kg bw/day. When rats were treated with α-hexylcinnamaldehyde (CAS No.-101-86-0) orally.
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