Registration Dossier
Registration Dossier
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EC number: 208-031-3 | CAS number: 506-30-9
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Parent Screening Test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: study report
- Title:
- Screening Information Data Set for Docosanoic acid
- Author:
- MHLW
- Year:
- 1 998
- Bibliographic source:
- Ministry of Health, Labour and Welfare (MHLW, former MHW), Japan (1998), Toxicity Testing Reports of Environmental Chemicals 6, 236-246.
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)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- Molecular formula:
- C22H44O2
- IUPAC Name:
- docosanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Docosanoic acid
- Substance type: Organic
- Physical state: Solid
- Analytical purity:85.9 %
- Impurities (identity and concentrations):(C14-C20) fatty acids (10.9 %) and C 24 fatty acid (2.3%)
- Storage condition of test material:Kept at room temperature until use
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: N/A
- Age at study initiation: 8 week old
- Weight at study initiation: 312.1-363.7 g for males, 205.3- 230.8 g for females.
- Fasting period before study: N/A
- Housing:N/A
- Diet (e.g. ad libitum):N/A
- Water (e.g. ad libitum):N/A
- Acclimation period:N/A
ENVIRONMENTAL CONDITIONS
- Temperature (°C):N/A
- Humidity (%):N/A
- Air changes (per hr):N/A
- Photoperiod (hrs dark / hrs light):N/A
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- corn oil
- Details on exposure:
- Males, 42 days; Females, from 14 days prior to mating to day 3 of lactation.
Premating exposure period: Male: 14 days, Female: 14 days
VEHICLE
- Justification for use and choice of vehicle (if other than water):corn oil - Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: at the most 14days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy : until proof of pregnancy (formation of vaginal closing or sperm detection in vagina) - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 42 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0(vehicle), 100, 300 or 1000 mg/kg/day.
Basis:
- No. of animals per sex per dose:
- 0(Vehicle) : 13 male and 13 female
100 mg/kg/day : 13 male and 13 female
300 mg/kg/day :13 male and 13 female
1000 mg/kg/day :13 male and 13 female - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Clinical signs were observed at least once a day.
Parent: Performed once a day
BODY WEIGHT: Yes
- Time schedule for examinations: once a week.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes,
Food consumption was measured nearly once a week except for mating period. - Oestrous cyclicity (parental animals):
- Estrous cycle length and pattern not performed.
- Sperm parameters (parental animals):
- Sperm examination were not performed.
- Postmortem examinations (parental animals):
- SACRIFICE
Males were killed on the day after the administration period. Females were sacrificed on the day 4 of lactation. Females with
no delivery were killed 4 days after the delivery expected date. Females with no copulation were sacrificed at the termination of mating period.
Parent: organ weight: heart, liver, kidneys, thymus, testes, epididymides.
Histopathological examinations: All animals in control and 1,000 mg/kg, and any organs which have histopathological changes at the higher doses: brain, heart, liver,spleen, thymus, kidney, adrenal, testis, epididymis, urinary bladder, ovary (only for females which were non pregnant or not
copulated). - Statistics:
- Dunnett’s or Scheffe’s test for continuous data, Chi square test for copulated index and fertility index, and Mann-Whitney U test or Fisher’s test for histopathological examination data.
- Reproductive indices:
- No. of pairs with successful copulation, copulation index (No. of pairs with successful copulation/No. of pairs mated x 100),pairing days until copulation, frequency of vaginal estrus, No. of pregnant females, fertility index = (No. of pregnant animals/No. of pairs with successful copulation x 100), No. of corpora lutea, No. of implantation sites, implantation index (No. of implantation sites/No. of corpora lutea x 100), No. of living pregnant females, No. of pregnant females with parturition, gestation length, No. of pregnant females with live pups on day 0, gestation index (No. of females with live pups/No. of living pregnant females x 100), No. of pregnant females with live pups on day 4, delivery index (No. of pups born/No. of implantation sites x 100), No. of pups alive on day 0 of lactation, live birth index (No. of live pups on day 0/No. of pups born x 100), sex ratio (Total No. of male pups/Total No. of female pups), No. of pups alive on day 4 of lactation, viability index (No. of live pups on day 4/No. of live pups on day 0 x 100), body wt. of live pups (on day 0 and 4)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No statistical significant difference from controls
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No statistical significant difference from controls
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No statistical significant difference from controls
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:
- other: No abnormalities were found in all reproductive parameters (fertility index, number of implantations and implantation index) in each dose group as well as no effects on mortality,body weight food consumption and organ weights.
- Remarks on result:
- other: not specified
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- 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 abnormalities were found in all pups examined in either the external observation at day 0 or the autopsy performed at day 4 after birth.
- Histopathological findings:
- no effects observed
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No treatment related adverse effects were found in either dose group up to 1000 mg/kg. Thus, the NOAEL (No Observed adverse effect level) for maternal toxicity of docosanoic acid was considered to be 1000 mg/kg/day.
- Executive summary:
The substance Docosanoic acid (CAS No : 112-85-6) was administered orally by gavage at three doses 100, 300 or 1000 mg/kg/day to groups of male/female Crj: CD(SD) rats. The compound showed no adverse effects on copulation or fertility. No changes related to the dosing of compound were observed in gestation length, gestation index, delivery and lactation.The compound did not demonstrate any adverse effects on the body weights, food consumption,mortality,organ weights or viability of pups.
Thus, the no observed adverse effect level (NOAEL) for maternal toxicity was considered to be 1000 mg/kg/day.
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