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EC number: 204-649-2
CAS number: 123-76-2
The NOAEL (No Observed Adverse Effect Level) for the test item 4-oxovaleric acid for TOXICITY in pregnant females was established as 500 mg/kg bw/day.
The NOAEL (No Observed Adverse Effect Level) for the test item 4-oxovaleric acid for PRENATAL DEVELOPMENT was established as 1000 mg/kg bw/day.
The test item was tested for prenatal developmental toxicity using the OECD Test Guideline No. 414, Prenatal Developmental Toxicity Study, Adopted by the Council on June 25th 2018.
There were no deaths of females during the study at any dose level. No adverse changes in health condition and no clinical symptoms of intoxication were observed in maternal animals following administration of the test item at any dose. In this prenatal developmental study the negative effect of the test item on the growth of maternal animals was observed at the highest dose level 1000 mg/kg bw/day. The body weight of treated females was decreased at the dose level 1000 mg/kg bw/day compared to the control group, on the 14th and 20th day of pregnancy statistically significantly. The body weight increments were significantly decreased at the dose levels 100 and 1000 mg/kg bw/day. Also value of corrected body weight of females was statistically significantly decreased compared to the control group at the highest dose level.
The weight reduction correlated with the decrease of food consumption in treated females at the highest dose. The food consumption of treated mothers was decreased from the 8th to 14th day of pregnancy at the dose level 1000 mg/kg bw/day, on the 8th day of the pregnancy with statistical significance.
Evaluation of uterus biometry detected decrease of absolute weights at the dose level 1000 mg/kg bw/day. This decrease in the absolute weight of the uterus was related to the lower necropsy body weight of the treated females whereas the relative uterine weight remains unchanged throughout all the treated as well as control groups.
Macroscopic structure of examined organs of pregnant females and reproduction parameters (number of females with live foetuses, number of live and dead foetuses, early and late resorptions) were unaffected by treatment with the test item.
Examination of the thyroid glands (absolute and relative weight of thyroid gland, histological examination of thyroid gland and serum levels of thyroid hormones) did not reveal any changes associated with the application of the test item.
Test item-related foetal mortality was not evident at any dose level. Detailed necropsy of foetuses did not reveal an increase of external and visceral variations and malformations at any dose level.
The mean body weights of foetuses were decreased at the dose level 500 and 1000 mg/kg bw/day compared to the control, but without statistical significance and dose dependence.
The mean AGD and corrected AGD of male and female foetuses in treated groups was not statistically significantly different from the control group.
No statistically significant differences with toxicological significance were recorded in number of litters during the statistical evaluation of skeletal findings.
Increased incidence of delayed ossification of some cranial bones (frontal bone, arcus zygomaticus, nasal bone) was observed at the dose levels 500 and 1000 mg/kg bw/day, without statistical significance and without dose relationship. These changes were not considered to be adverse due to their reversibility in postnatal life.
The NOAEL (No Observed Adverse Effect Level) for the test item for TOXICITY in pregnant females was established as 500 mg/kg bw/day.
NOAEL value is based on no mortality of females, no altered growth, no changes in health condition status, no alteration to thyroid parameters, no pathological findings in the dams and no dose related changes in reproduction parameters up to 500 mg/kg bw/day.
The NOAEL (No Observed Adverse Effect Level) for the test item for PRENATAL DEVELOPMENT was established as 1000 mg/kg bw/day.
This NOAEL is based on no altered growth and no significant treatment-related structural abnormalities in foetuses of pregnant rats dosed up to 1000 mg/kg bw/day.
According to the CLP Regulation (EC 1272/2008), "Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1. If deficiencies in the study make the quality of evidence less convincing, Category 2 could be the more appropriate classification.
Such effects shall have been observed in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects."
The available experimental data are adequate for classification and labelling and the substance is not classified for reproductive and developmental toxicity according to the CLP Regulation (EC 1272/2008).
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