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EC number: 500-281-4
CAS number: 98362-33-5
The objective of this study was to provide data on the sub-acute
(15-day) toxicity in rats of the test item after exposure by inhalation.
The results of this 15-day study may serve as a basis for selection of
the concentration levels for a future sub-chronic (90-day) inhalation
study with this substance.
The inhalation toxicity of the test item was studied in a
sub-acute (15-day) inhalation toxicity study in Wistar rats. Four groups
of 6 male rats were exposed nose-only to target concentrations of 0
(control) 20, 200 or 2000 mg/m3 of the test material for 6 hours/day, 5
days/week over a 15-day period, with a total of 10 exposure days.
Observations and measurements to detect adverse effects included daily
clinical observations, body weight, food consumption, organ weights and
macroscopic examination at sacrifice on the day after the last exposure.
The mean actual concentrations (± standard deviation) of the test
item (solvent free), based on gravimetric analysis, were 31 (± 16), 202
(± 10) and 2032 (± 139) mg/m3 for the low, mid and high concentration
level, respectively. The average particle size (Mass Median Aerodynamic
Diameter; MMAD) was 1.29 µm (with a geometric standard derviation (gsd)
of 2.11), 1.49 µm (gsd of 2.40) and 2.45 µm (gsd of 2.13) for the low,
mid and high concentration test atmospheres, respectively.
All animals survived until scheduled sacrifice. Treatment-related
clinical signs were seen in the high concentration group only and
consisted of dyspnoea (4 animals) and blepharospasm (2 animals) after
the first exposure, and grunting (1 animal) prior to exposure on days
In the second week of the study, growth was reduced,
concentration-dependently, in all groups exposed to the test material.
This effect was most marked on the days that the animals were exposed
(between days 7 and 10, most animals of the mid and high concentration
groups lost weight). Growth data of the first week were inconclusive due
to wide inter animal variation which probably resulted from the switch
from pelleted to powdered feed on the day before initiation of
treatment. Despite the effect on growth, mean body weights showed no
statistically significant intergroup differences. Therefore, the effect
on growth was considered to be of little toxicological significance.
Food consumption was decreased on the first exposure day in the
high concentration group and, to a limited degree, in the second week in
all exposed groups.
Absolute and relative lung weight and relative kidney weight were
statistically significantly increased in the high concentration group.
Macroscopic examination at scheduled sacrifice showed incompletely
collapsed lungs (two animals) and patches on the lung (one animal) in
the high concentration group.These findings were possibly related
Under the conditions of this study no adverse effects occurred in
the low and mid concentration groups. Therefore, the mid concentration
of 202 mg/m3 (actual concentration measured by gravimetry) was a
No-Observed-Adverse-Effect-Concentration (NOAEC) of 2,3-Epoxypropyl
neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
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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