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EC number: 629-765-4
CAS number: 1226892-44-9
No data on acute toxicity is available for"Fatty acids C18 unsat,
reaction products with triethylenetetramine" (or TO + TETA). Read-across
is performed with ""Fatty acids C18 unsat, reaction products with
diethylenetetramine" (or TO + DETA).
Acute Oral Toxicity LD50 > 2000 mg/kg for rat (LD50 cut-off: 2500
mg/kg bw). No acute dermal and inhalation toxicity studies were
performed on the substance due to its corrosive properties.
Assessment of acute oral toxicity with Tall
oil diethylenetriamine imidazoline in the rat (Acute Toxic Class
The study was carried out based on the
guidelines described in:
OECD No.423 (2001) "Acute Oral Toxicity,
Acute Toxic Class Method"
Commission Regulation (EC) No 440/2008, B1
tris: "Acute Oral Toxicity, Acute Toxic Class Method"
EPA, OPPTS 870.1100 (2002), "Acute Oral
JMAFF guidelines (2000) including the most
recent partial revisions.
Initially, Tall oil diethylenetriamine
imidazoline was administered by oral gavage to three female Wistar rats
at 300 mg/kg body weight. In a stepwise procedure additional groups of
females were dosed at 300 and 2000 mg/kg body weight. All animals were
subjected to daily observations and weekly determination of body weight.
Macroscopic examination was performed on the day of death or after
terminal sacrifice (Day 15).
One female at 2000 mg/kg was found dead on
Day 4. No (further) mortality occurred at 300 and 2000 mg/kg.
Clinical signs observed during the study
period were as follows:
Hunched posture, piloerection, lethargy,
uncoordinated movements, rales, lean appearance and/or ptosis between
Days 1 and 2; one female showed hunched posture and rales throughout the
observation period, along with lean appearance and piloerection on Day
Hunched posture, piloerection and/or
lethargy between Days 1 and 5.
One female at 300 mg/kg showed body weight
loss throughout the observation period. Other animals at 300 mg/kg
showed normal body weight gain.
One female at 2000 mg/kg found dead on Day 4
showed body weight loss between Days 1 and 4. Three other females at
2000 mg/kg showed no body weight gain or slight body weight loss between
Days 1 and 8. Body weight gain among the (other) surviving females at
2000 mg/kg during the (remainder of the) observation period was
considered to be normal.
One female at 300 mg/kg showed gaseous
distension of the gastro-intestinal tract. No further macroscopic
abnormalities were noted among other animals at 300 mg/kg.
Three females at 2000 mg/kg showed a stomach
and right lateral lobe of the liver grown together with the diaphragm.
No macroscopic abnormalities were noted in the other animals at 2000
mg/kg, including the female found dead on Day 4.
No explanation could be found for the
differing macroscopic findings between the two treated groups at 2000
The oral LD50 value of Tall oil
diethylenetriamine imidazoline in Wistar rats was established to exceed
2000 mg/kg body weight.
According to the OECD 423 test guideline,
the LD50 cut-off value was considered to be 2500 mg/kg body weight.
As explained in
the category justification, For cross-reading in general use is made
with data of same or lower EA-length where available, and that of Tall
oil + DETA representing the worst case. This dossier is for the
substance "Fatty acids C18 unsat, reaction products with
triethylenetetramine" (or TO + TETA). As for the substance itself no
toxicological information is available, cross-reading has been applied
to TO + DETA.
Tall oil + DETA
was tested for acute oral toxicity in two different studies, both
according to acute toxic class method. Both studies show the same
outcome showing 1 resp. 2 deaths out of 6 dosed at 2000 mg/kg, and no
mortality at 300 mg/kg.
At 300 mg
clinical signs included Hunched posture, piloerection, lethargy,
uncoordinated movements, hypersalivation, dyspnoea, and/or lean
appearance, which in an incidental animal lasted until the end of the
All other studies
with AAI substances show similar acute oral toxicity,
all with a LD50 > 2000 mg/kg bw. There is possibly a small tendency of
decreased toxicity with increasing size of the EA.
Acute toxicity amidazolines:
TO + DETA >2000
mg/kg bw ,Cat.5; ATC cut off 2500mg/kg
TO + DETA >2000
mg/kg bw, Cat.5; ATC cut off 2500mg/kg
TO + TEPA >2000
mg/kg bw, Cat.5; ATC cut off 2500mg/kg
C16-18,C18 unsat+TEPA>2000 mg/kg
bw, Cat.5; Limit test 20% mortality
TO + Poly(Amide) >2000
mg/kg bw ,Cat.5; ATC cut off 5000mg/kg
Acute dermal toxicity: AAI are
corrosive to the skin. Testing for acute dermal toxicity is therefore
not justified. Toxicity following dermal exposure is characterised by
local tissue damage, rather than the result of percutaneously absorbed
Acute inhalation toxicity:
Physical-chemical properties of AAI indicate a low likelihood for
exposure via inhalation having a boiling point > 300 °C and a low vapour
pressure (0.00017 mPa at 25°C for DETA based AAI).
Furthermore, the substance is
classified as corrosive and no acute toxicity testing should normally be
Acute oral exposure of Tall oil + DETA
show limited acute toxicity, with a LD50 above 2000 mg/kg bw. Hence no
classification is required.
Acute dermal testing with corrosive
materials is not justified. As a consequence no classification can be
made for acute dermal toxicity. Effects will be characterised by local
tissue damage. Systemic uptake via skin is likely to be very limited.
The low acute oral toxicity indicate a low systemic toxicity.
No classification for acute dermal
toxicity is therefore indicated.
Also for acute inhalation toxicity
information for classification is lacking, and is testing not justified.
Due to very low vapour pressure is the likelihood of exposure low.
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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