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EC number: 254-075-1
CAS number: 38668-48-3
Based on an OECD Guideline 422 and GLP study with
diisopropanol-p-toluidin, the NOAEL for reproductive toxicity was
considered to be 20 mg/kg bw/day for all relevant endpoints, which was
the highest dose tested in female animals.
stability of the test substance in corn oil was demonstrated over a
period of 7 days at room temperature. The analytically determined test
substance concentrations in the vehicle were in the expected range of
the nominal concentrations (91.5 -103.2%) for all formulations.
Combined Repeated dose Toxicity study with
the Reproduction/Developmental Toxicity Screening Test: oral route
In a combined repeated dose toxicity study
with the reproduction/developmental toxicity screening test (BASF SE,
2013, OECD 422) diisopropanol-p-toluidin was administered to Wistar rats
(4 groups of 10 male and 10 female animals each) via oral gavage at dose
levels of 0, 2.5, 10, 40 mg/kg bw/day (males) and 20 [40 on pre-mating
day 0] mg/kg bw/day (females). The duration of treatment covered a
2-week pre-mating and mating period in both sexes, approximately 1 week
post-mating in males, and the entire gestation period as well as 4 days
of lactation and two weeks thereafter in females. Mortality, clinical
signs, body weight, food and water consumption were assessed at regular
intervals. At the end of the study functional observation battery and
motor activity parameters were determined. Clinicochemical and
hematological examinations as well as urinalyses were performed in 5
animals per sex and group towards the end of the administration period.
At necropsy, selected organs were weighed and the animals were examined
macroscopically and histopathologically. Relevant reproductive
parameters and indices were determined. The pups were sexed,weighed and
examined for macroscopically evident changes. Their viability was
recorded. At necropsy, all pups were sacrificed under isoflurane
anesthesia with CO2 and examined macroscopically for external and
No mortality and no clinical signs were
observed for male animals. Three female animals of the high dose group
(40 mg/kg bw/d) were found dead on premating day 1. In addition, nine
females showed severe tremors on premating day 1. After reduction of the
dose level to 20 mg/kg bw in female animals no signs of general systemic
toxicity were observed. No treatment-related effects were observed in
mean body weight, body weight changes, food and water consumption of
exposed animals throughout the study. Neurological testing did not
indicate any neurotoxic potential of the test item. No treatment related
changes among hematological, clinical chemistry and urinalysis
parameters were observed. When compared to the control (set up 100%),
the mean absolute liver weights were significantly increased in male
animals of the 2.5 and 40 mg/kg bw/d dose group. Absolute liver weights
of male animals did not show a dose response, there were no significant
changes in relative liver weights, and a histopathological correlate was
not detected, therefore increased absolute liver weights were regarded
as incidental. All other mean absolute weight parameters in males and
all weight parameters in females did not show significant differences
when compared to the control group. At gross lesions and histopathology
examination all findings were considered to be incidental or were
biologically equally distributed over control and treatment groups.
Parameters for reproductive performance i.e. male and female mating and
fertility index, gestation index and postimplantation loss revealed no
test substance-related adverse findings. Two mating pairs of the low
dose group, one pair of the mid dose group and three pairs high dose
group were recorded as not pregnant. Thereby, two male animals of the
high dose group showed gross lesions and histopathological findings. The
findings were considered to be incidental or spontaneous in origin and
without relation to treatment. For F1 pups, viability/mortality, sex
ratio, clinical observation, body weight data and necropsy examinations
indicated no adverse findings and were assessed as being spontaneous in
nature and without biological relevance. In conclusion, based on
mortality and tremors noted at 40 mg/kg bw/d the No Observed Adverse
Effect Level (NOAEL) for females was established at 20 mg/kg bw/day. As
no systemic toxicity was observed in males the NOAEL was established at
40 mg/kg bw/d. Due to the lack of any relevant findings the NOAEL for
reproductive performance and fertility as well as the NOAEL for
developmental toxicity in the F1 progeny was considered to be 40 mg/kg
bw/d in males and 20 mg/kg bw/d in females.
In an OECD Guideline 414 and GLP study with diisopropanol-p-toluidin in rats, the NOAEL for maternal and prenatal developmental toxicity was 20 mg/kg/day, which was the highest dose tested in female animals.
Under the conditions of this prenatal developmental toxicity study, the
oral administration of Diisopropanol-p-toluidin to pregnant Wistar rats
from implantation to one day prior to the expected day of parturition
(GD 6-19) at doses as high as 20 mg/kg bw/d caused neither evidence of
maternal nor developmental toxicity.
In conclusion, the no observed adverse effect level (NOAEL) for maternal
and prenatal developmental toxicity is the highest tested dose of 20
Prenatal Developmental Toxicity Study in Wistar Rats Oral Administration
In a prenatal developmental toxicity study, the test substance
diisopropanol-p-toluidin was administered to pregnant Wistar rats daily
by gavage from implantation to one day prior to the expected day of
parturition (GD 6-19) to evaluate its potential maternal and prenatal
Neither clinical examinations nor determination of food consumption and
body weights revealed any relevant difference between animals receiving
2.5, 7 or 20 mg/kg bw/d diisopropanol-p-toluidin and the control. No
differences of toxicological relevance between the control and the
treated groups were determined for any reproductive parameters, such as
conception rate, mean number of corpora
lutea, mean number of implantations, as well as pre- and
postimplantation loss. Similarly, no influence of the test substance on
fetal weight and sex distribution of the fetuses was noted at any dose.
Overall, there was no evidence for toxicologically relevant adverse
effects of the test substance on fetal morphology at any dose.
Based on the results obtained from
reproduction/developmental testing (OECD 422, OECD 414), the test
substance is not considered to be subject to classification and
labelling for toxicity to reproduction/development according to
Regulation (EC) No 1272/2008 (CLP).
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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