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: 203-127-1
CAS number: 103-60-6
Dermal NOAEL > 1000 mg/kg bw/day, 90 days rat male/female, methodolgy similar to OECD 411, Mulhern et al. (1990).
The subchronic dermal toxicity of the test material was investigated
following a procedure in line with that noted in the standardised
guideline OECD 411. During the study groups of 12 male and 12 female
rats were dosed daily with test material via topical application under
an occlusive dressing, for a period of 6 hours per day for 13
consecutive weeks. The groups were dosed at a constant volume of 2 mL/kg
bw at concentrations of 100, 300 and 1000 mg/kg bw/day in diethyl
phalate. A vehicle control was run concurrently for comparison.
Under the conditions of the study there were no notable intergroup
differences or toxicologically significant effects noted when assessing
changes in; body weight, food consumption, water consumption,
haematology, clinical chemistry, urinalysis, organ weights, necropsy
findings or histological findings. Transient incidences of slight
desquamation and erythema were observed, in all animals at similar
incidence and severity.
Overall, exposing rats to the test material for 13 weeks with at dose
levels of up to 1000 mg/kg bw/day produced no notable findings. The NOEL
was therefore taken to be > 1000 mg/kg bw/day.
The supporting study, Api (2004), determined the repeated dose toxicity
of the test material in a study performed to sound scientific
principles. Sprague-Dawley CD rats (12 per sex per dose) were exposed to
the test material at 0, 100, 300 or 1000 mg/kg bw/day for 6 hours per
day over thirteen consecutive weeks. Animals were observed for clinical
signs, skin irritation, body weight, food consumption and water
consumption. Samples were also collected from 10 males and 10 females
for urinalysis, haematology and clinical blood chemistry. After 13 weeks
of dosing, animals were sacrificed and necropsied. Selected organs were
examined and weighed. Histopathologic examinations were performed on
major tissues from all animals in the control and high-dose groups and
the kidneys from all dose groups. The control and test group animals all
exhibited transient, slight desquamation and erythema of the skin
sporadically throughout the dosing period. Body weight and food
consumption showed only normal variability. No treatment related effects
were detected in the clinical observations, mortality, haematology,
blood chemistry, urinalysis or findings at necropsy, and
histopathological examination. Under the conditions of the test, no
local skin irritation or systemic signs of toxicity were observed up to
the maximum concentration tested. Therefore the NOEL was determined to
be greater than 1000 mg/kg bw/day. This study was reported with a
sufficient level of detail to assess the quality of the submitted data
and was assigned a reliability score of 2, in accordance with Klimisch
Owston et al. (1981) was also provided as supporting evidence on the
basis of read-across to phenyethyl alcohol.The read-across approach has
been used since phenylethyl alcohol is structurally similar to the test
material but is more toxicologically active. The results presented are
therefore taken to be the worst case scenario.Phenethyl alcohol was
administered percutaneously to groups of Sprague-Dawley rats (15
rats/sex/dose) at 0, 0.25, 0.50, 1.00 or 2.00 mL/kg bw/day for 90 days.
Control animals were not shaved and did not receive any treatment.
Animals were observed for clinical symptoms of toxicity and behavioural
abnormalities. Body weights and food consumption were examined weekly.
Ophthalmic examinations were performed on the eyes of all animals before
treatment and at week 13. Blood samples were collected at weeks 6 and 13
for haematology and clinical chemistry analysis. The rats were
sacrificed at week 13 and autopsied. Microscopic examination of tissues
was performed. Weight gain was depressed in both sexes given 1.00 or
2.00 mL/kg bw/day. No effect on food intake was observed. Survival rate
was unaffected and ophthalmological examination was unremarkable. Male
rats dosed with 2.00 mL/kg bw/day revealed a decrease in haemoglobin
concentration and white blood cell count at weeks 6 and 13. Organ weight
measurement at all dose levels and microscopic examination of a large
variety of tissues did not reveal any treatment related effects.
Significant increases in the relative weights of brain, kidneys and
gonads occurred in the 2.00 mL/kg bw/day, and were related to the
reduced body weights. Relative liver weights were increased at all doses
among the females and both absolute and relative liver weights were
decreased in males given 1.00 mL/kg bw/day. The decrease in liver
weights noted in the males at 1.00 mL/kg bw/day was not observed in the
2.00 mL/kg bw/day group and was not considered to be toxicological
significant. The NOEL for phenyethyl alcohol was determined to be 0.50
mL/kg bw/day, which based on the read-across approach, was considered to
be the worst case scenario for the substance to be registered. The study
provides sufficient details on material and methods, and also a detailed
description of the results, but only body weight data are presented. The
study appears to have been conducted in line with good scientific
principles and is in basic compliance with the standardised OECD
guideline. In line with Klimisch (1997) the study was assigned a
reliability score of 2.
Repeated Dose Oral and Inhalation Toxicity
Exposure via the dermal route is the most appropriate route of exposure
for the submitted substance. Further testing either via inhalation or
the oral route are considered less appropriate and have been omitted on
According to the criteria outlined in Regulation (EC) No. 1272/2008 and
Directive 67/548/EEC, the substance does not meet the criteria for
classification as under repeat dose toxicity and specific organ toxicity.
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.
Do not show this message again