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EC number: 208-807-1
CAS number: 542-28-9
The stability of the test substance in corn
oil was demonstrated over a period of 7 days at room temperature. As the
mixtures were stored no longer than this time period, the stability was
Homogeneity control analyses
Considering the low relative standard
deviation in the homogeneity analysis, it can be concluded that
Delta-Valerolactone was distributed homogeneously in corn oil.
Concentration control analyses
The concentration control analyses of all
concentrations revealed that the values were in the expected range of
the target concentrations, i.e. were always in a range of 90-110% of the
nominal concentrations. Taken together, the results demonstrate the
correctness of the concentrations of Delta-Valerolactone.
Toxicity to reproduction: oral in
In a combined repeated dose toxicity
study with the reproduction/developmental toxicity screening test (BASF
SE, 2013) Delta-Valerolactone was administered orally by gavage to
groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels
of 0 mg/kg bw/day (test group 0), 100 mg/kg bw/d (test group 1), 300
mg/kg bw/d (test group 2) and 1000 mg/kg bw/d (test group 3). The
animals of the control group were treated in the same way with the
vehicle only (corn oil). Fourteen days after the beginning of treatment,
males and females from the same test group were mated. The duration of
treatment covered a 2-week pre-mating and mating period in both sexes,
approximately 3 week post-mating in males, and the entire gestation
period as well as 4 days of lactation in females followed by an
additional treatment until one day before sacrifice. Clinical and
detailed clinical signs, food and water consumption as well as body
weight development and gain were determined repeatelly during the study
period. Towards study end, clinicochemical and haematological
examinations, urinalysis and a functional observation battery incl.
motor activity measurements were performed. After sacrifice, parental
animals were examined by gross pathology. Selected organs were weighed
and a histopathological examination was performed. Pups were sexed and
macroscopically examined on PND0. Viability was recorded. They were
weighed on PND1 and PND4. Necropsy was performed on PND4. All pups were
examined macroscopically for external and visceral findings. Since a
detailed study summary and conclusion is already presented in the
section on repeated dose toxicity (section 7.5), the results are only
Number and status at delivery:
The mean number of delivered pups per
dam and the rate of liveborn and stillborn pups were not affected by the
A direct effect of the test substance
on the pups was not observed.
The sex distribution and sex ratios of
live F1 pups on the day of birth and on PND 4 did not show biologically
relevant differences between test groups.
The occurrence of reduced nutritional
status in two litters was assessed as being secondary to the impaired
maternal condition due to local toxicity. A direct effect of the test
substance on the pups was not assumed.
All observed findings were assessed as
All findings observed were assessed as
being incidental and not related to treatment.
Waiver: 2-generation reproduction
According to REACH regulation Annex IX
column 1 additional testing for toxicity to reproduction is not
necessary because the available data on repeated dose toxicity (Combined
Repeated Dose Toxicity Study with the Reproduction/Developmental
Toxicity Screening Test) did not indicate adverse effects on
reproductive organs, tissues or behaviour.
In a prenatal developmental toxicity study in rats according to OECD 414, Delta-Valerolactone was administered once daily by oral gavage from days 6 to 20 post-coitum at doses of 100, 300 and 1000 mg/kg bw/day. The rats of the control group received the vehicle, corn oil, alone. No maternal or developmental toxicity was observed up to the limit dose of 1000 mg/kg bw/day.Thus, the maternal and developmental No Observed Adverse Effect Level (NOAEL) for Delta-Valerolactone was established as being at least 1000 mg/kg bw/day.
Classification is not warranted
according to the criteria of EU Directive 67/548/EEC and Regulation
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.
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