Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 930-592-4 | CAS number: -
Table: Reproduction data
Dose level (mg/kg/day)
Pairs started (N)
Females showing evidence of copulation (N)
Females achieving pregnancy (N)
Females with abortion (N)
Conceiving days (duration of mating) 1 – 5 (N)
Conceiving days (duration of mating) 6 – 13 (N)
Pregnancy ≤ 21 days (N)
Pregnancy = 22 days (N)
Pregnancy ≥ 23 days (N)
Females with live pups born (N)
Females with live pups at day 4 after parturition (N)
Corpora lutea/pregnant females (average)
Implantations/pregnant females (average)
Live pups/mother at birth (average)
Live pups/mother at day 4 after parturition (average)
Sex ratio (M/F) at birth (average)
Sex ratio (M/F) at day 4 after parturition (average)
Litter weight at birth (average)
Litter weight at day 4 after parturition (average)
Pup weight at birth (average)
Pup weight at day 4 after parturition (average)
Mothers with 0 (N)
Mothers with 1 (N)
Mothers with ≥ 2 (N)
(N) – number of animals, M/F – males /females
Table: Fertility parameters
Fertility index (%)
Conception index (%)
Gestation index (%)
Percentage of postnatal loss
LOSS OF OFFSPRING
Pre-implantation (corpora lutea minus implants)
Pregnant females with 0 – 5 (N)
Pregnant females with 6 - 10 (N)
Pregnant females with 11 - 15 (N)
Pregnant females with ≥ 16 (N)
Post-implantations (implants minus live births)
Pregnant females with 0 (N)
Pregnant females with 1 (N)
Pregnant females with 2 (N)
Pregnant females with ≥ 3 (N)
Post-natal (live births minus alive at post-natal day 4)
The test substance - Reaction product of Distillates (petroleum), acid-treated heavy naphtenic and calcium oxide - was tested for reproduction toxicity using the OECD Test Guideline No. 421 Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on July 27th 1995.
Wistar rats of SPF quality were used for testing. The test substance was administered dissolved in olive oil using a stomach tube; oral application of rats was made daily. The concentrations of suspensions at all dose levels were adjusted to ensure the administered volume of 1 mL per of body weight. Four groups of animals were included in the study - 3 treated groups (doses 160, 400, 1000 mg/kg of body weight/day) and one control group (vehicle only). Each group consisted of 12 males and 12 females. The dose levels for study – 160, 400 and 1000 mg/kg/day were chosen on the basis of the results of the Dose-range finding experiment with 14-day application period.
The treated groups were administered daily for the following periods:
males and females – 2 weeks prior to the mating period and during the mating period,
pregnant females – during pregnancy and till the 3rd day of lactation,
males – after mating period – totally for 28 days,
nonpregnant females (mated females without parturition) – for 25 days after the confirmed mating.
During the study clinical observation and health status control were performed daily. The body weight and food consumption were measured weekly or in specified time intervals. Vaginal smears were prepared daily during mating period (until the presence of spermatozoa). Reproduction parameters relevant to pups (number of pups, weight of litters, sex or vitality) were also recorded.
The study was finished by gross necropsy of animals. In all males of all groups the sperm parameters: sperm motility and sperm morphology were examined. The selected organs from parental animals were removed for weighing and histopathological examination.
Body weight, food consumption, clinical status and macroscopic structure of reproductive organs of treated parental males were unaffected by treatment of the test substance.
A statistically significant difference was detected in the weight of the prostate gland – an absolute and relative weight was statistically significantly increased in males at the dose level of 1000 mg/kg/day. In absence of any changes of microscopic structure of the pituitary gland, the effect could be considered not to be of toxicological importance.
The test substance had effect on the microscopical structure of the testes without treatment-related damage of spermiogenesis. Histopathological examination of testes of parental males showed increased incidence of irrelevant changes: atrophies of germ epithelium (only sporadic or in less than 10% of the tubules), alteration of tubules in testes and vacuolations of cytoplasm of spermiogonia in males. Above mentioned histopathological changes occurred only in sporadic testicular tubules and did not negatively influence fertility of parental treated males, therefore they were not considered to be adverse.
Clinical status, weight and structure of reproductive organs of treated parental females were not significantly affected by treatment of the test substance.
Growth and food consumption of parental females was slightly but insignificantly influenced by the test substance administration.
The number of corpora lutea, implantations, number of pups and accompanied weight of litter were significantly influenced by the administration of the test substance (decrease 1000 mg/kg/day). Sex ratio, average weight of pups and postnatal development of pups were unaffected. Macroscopic abnormalities were described sporadically in pups of the highest dose level.
Number of females achieving pregnancy, number of females bearing live pups and number of females with live pups at day 4 after parturition in treated groups were similar to the control or higher than the control groups. Duration of mating and pregnancy were similar in the control and treated females.
Pre-implantation, post-implantation and postnatal losses were relatively well balanced at the treated groups and control group.
The NOAEL (No Observed Adverse Effect Level) for the REPRODUCTION of males was established at 1000 mg/kg body weight/day.
The NOAEL (No Observed Adverse Effect Level) for the REPRODUCTION of females was established at 400 mg/kg body weight/day.
The NOAEL (No Observed Adverse Effect Level) for the DEVELOPMENT of pups was established at 1000 mg/kg body weight/day.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again