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EC number: 249-044-4
CAS number: 28472-97-1
Acute rral (OECD 401): LD50 > 2000 mg/kg bw Acute dermal: LD50 > 2000 mg/kg bw Acute inhalation: RA-A from CAS 103-23-1: LC50 > 5.7 mg/L; RA-A from CAS 16958-92-2: LC50 > 3.2 mg/LStudies on acute inhalation toxicity were available for the following Read Across substances (CAS No.): 103-23-1 and 16958-92-2
Justification for grouping of substances and read-across
There are no data available on the acute inhalation toxicity of
diisodecyl azelate (CAS 28472-97-1). In order to fulfil the standard
information requirements set out in Annex VII, 8.5, in accordance with
Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from
structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006,
"information on intrinsic properties of substances may be generated by
means other than tests, provided that the conditions set out in Annex XI
are met.” In particular for human toxicity, information shall be
generated whenever possible by means other than vertebrate animal tests,
which includes the use of information from structurally related
substances (grouping or read-across).
Having regard to the general rules for grouping of substances and
read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC)
No 1907/2006 whereby substances may be predicted as similar provided
that their physicochemical, toxicological and ecotoxicological
properties are likely to be similar or follow a regular pattern as a
result of structural similarity.
Overview of acute toxicity
Acute toxicity Oral
Acute toxicity inhalation
Acute toxicity dermal
Experimental result:LD50 >2000 mg/kg bw (rat)
RA: CAS 103-23-1
RA: CAS 16958-92-2
Experimental result:LC50 >5.7 mg/L air (analytical)
Experimental result:LC50 >3.2 mg/L air (analytical)
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font.
Lack of data for a given endpoint is indicated by “--“.
The above mentioned substances are considered to be similar on the basis
of the structural similar properties and/or activities. The available
endpoint information is used to predict the same endpoints for
diisodecyl azelate (CAS 28472-97-1). A detailed analogue approach
justification is provided in the technical dossier (see IUCLID Section
Acute oral toxicity
An acute oral toxicity study with diisodecyl azelate was performed
according to OECD guideline 401 (Bien, 1993). Male and female Bor: WISW
(SPF cbp) rats were orally exposed to a single dose volume of 2.17 mL/kg
bw of the test substance to achieve a dose of 2000 mg/kg bw in a limit
test. No abnormal clinical signs or body weight changes were observed in
the 14 days observation period. No deaths occurred. Therefore the LD50
under the given conditions was set to >2000mg/kg bw.
Acute inhalation toxicity
The acute inhalation toxicity of Bis(2-ethylhexyl) adipate (CAS
103-23-1) was investigated in a limit test conducted according to OECD
guideline 403 and GLP (Gamer, 1998). 5 Wistar rats per sex were exposed
to the test substance as a liquid aerosol (MMAD= 1.4 µm) at an
analytically determined concentration of 5.688 mg/L for 4 h using a
nose/head only exposure system. No mortality occurred throughout the
study period. Clinical signs of toxicity included irregular and
accelerated respiration as well as attempts to escape and piloerection
and were completely subsided from post dosing day 5 onward. Body weights
were not affected by treatment and no abnormalities were noted at gross
pathology. Based on these results, the LC50 value for male and female
Wistar rats was assumed to be greater than 5.7 mg/L air.
The acute inhalation toxicity of Bis(tridecyl) adipate was investigated
in a study similar to OECD guideline 403 (Dalbey, 1989). Groups of 10
Sprague Dawley rats per sex were exposed to analytical atmosphere
concentrations of the test aerosol of 0.5 and 3.2 mg/L (highest
achievable dose) for 4 h using a whole body exposure system. In
addition, 10 control animals per sex were sham-exposed. An interim
sacrifice of 5 males and 5 females of each group was performed 1 day
after exposure to the test aerosol. No mortality and no clinical signs
of toxicity were observed in any of the animals during the 1- or 14-day
observation period. Body and organ weights were not affected by
treatment and no abnormalities were noted at gross pathology. The
histopathological examination did not reveal any substance-related
changes in any of the organs examined (lungs, nasal turbinates, liver,
kidney and tracheobronchial lymph node). Based on these results, the
LC50 value for male and female Sprague Dawley rats was assumed to be
greater than 3.2 mg/L air.
Acute dermal toxicity
The dermal route was tested in male and female Wistar rats according to
OECD guideline 402 (van Otterdijk, 2010). Dermal exposure of 2000 mg
diisodecyl azelate /kg bw for 24 h led to no mortalities within the
observation period of 14 days. Flat posture and/or chromodacryorrhoea
was observed among several animals on Day 1. Scales were seen in the
treated skin-area of several animals between Days 4 and 13. Body weight
gain was assumed to be normal in this study and no abnormalities were
found at macroscopic post mortem examination of the animals. The LD50
for acute dermal exposure of diisodecyl azelate was set to be >2000
Conclusions for acute toxicity
In summary, the acute oral toxicity study with diisodecyl azelate (CAS
28472-97-1) showed a LD50 value greater than 2000 mg/kg bw. For acute
inhalation toxicity, two studies are available from the structurally
similar substances bis(2-ethylhexyl) adipate (CAS 103-23-1) and
bis(tridecyl) adipate (CAS 16958-92-2). From these studies LC50 values,
of >3.2 and > 5.7 mg/L air were determined for male and female rats at
the highest achievable doses. Acute dermal toxicity data with diisodecyl
azelate (CAS 28472-97-1) showed no effects at the limit dose of 2000
Thus, the available data on diisodecyl azelate (CAS 28472-97-1) and
structural analogues indicate a very low level of acute toxicity and
thus no hazard for acute oral, dermal and inhalation toxicity was
Based on substance-specific studies and read-across from structurally
similar substances, the available data on the acute oral, dermal and
inhalation toxicity do not meet the classification criteria according to
Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore
conclusive but not sufficient for classification.
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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