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EC number: 701-390-1
CAS number: -
information indicates that Tallow tripropylenetetramine is corrosive to
of dermal lesions (following 4-h application)
Days after application
Mean score erythema
Mean score oedema
= abnormal fur growth; Fr = reduced fur growth; D = desquamation; T =
thickening of skin; R= reactions extending beyond treatment site; Hy =
hyperkeratinisation; Br = brown discolourisation of skin; L = loss of
skin suppleness; H = haemorrhage of dermal capillaries; Gr = green
discoulorisation of skin; Tf = transverse folding of skin; Fi =
fissuring of skin; Sc = small scattered scabs; Gs = glossy skin, E =
eschar, P = pink coloured and shiny skin
A study was performed to assess the effects
of Amine 760 on the irritancy potential to the skin of the New Zealand
White rabbit. The method used was based on that described in the OECD
Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal
A three minute, 1 hour and 4 hours,
semi-occluded dermal application of the test material to the intact skin
of three rabbits followed by a decontamination procedure with acetone
produced irritation scores directly after patch removal and 1,2 and 3
scores for erythema were observed in all animals during first 3 days and
in two animals accompanied by eschar formation even until day 7, with
desquamation in all three animals. At end of observation period on day
14, all animals show pink and shiny skin and in two animals desquamation
is still visible. Although the report indicate no visible necrosis, the
seriousness of the effects, only partial recovery, and pink shiny
colouration indicative of skin recovery after damage, it is probably
prudent to classify as corrosive.
A very slight erythema was observed in 2 rabbits at 1 hour after the patch removal.
At 24h, 48h and 72h, the above-mentioned 2 rabbits exhibited a well-defined erythema (grade 2) that persisted up to day 5.
The third rabbit only presented a very slight erythema at 24h and 48h. This grade 1 erythema disappeared at 72h.
A very slight to slight oedema was noted at 24h, 48h and 72h in 2 rabbits. No oedema was found in the third rabbit.
Whereas a very slight to slight (grade 1 and 2 respectively) or even no erythema was found in 2 rabbits, a moderate to severe (grade 3 to 4)
erythema was observed in the third rabbit up to day 5.
A very slight to slight odemas were observed in 2 rabbits. They worsened thereafter, reaching a grade 4 at 24h and 72h,
and steadily retroceded afterwards (up to completely disappear on day 8).
E Removal of excess product using a
gauze pad soaked in distilled water
A Dry skin
* Reading the erythema around the
application site; application site: beginning of necrosis - brown skin -
- No more scoring when signs of
Reported in French. GLP, standard test: 3
rabbit exposed for 3 minutes and a further three rabbits were exposed
for 1 hour. After exposure period excess material was wiped off with
moistened cloth. Results: One hour after exposure are signs of dermal
irritation very weak in the animals exposed for 3 minutes, and moderate
in the others. After 24 hours are reactions increased in both groups.
The report concludes that the substance is corrosive following 1 hour
application. However, the effects of corrosion are not conclusive.
Specifically, no ulcers, bleeding or bloody scabs were observed in any
of the animals. Only 'top necrosis' is mentioned for one animal with
crusts visible until day 9, after which all effects had cleared.
However, considering the serious skin effects observed after one hour
exposure, for which classification as corrosive is disputable, it is
prudent to certainly assume corrosion following a four times longer
exposure of 4 hours.
See attached table Individual irritation
One rabbit was exposed to three samples of
0.5 grams of Oleyl tripropylenetetramine applied to separate skin-sites
on intact, clipped skin using a semi-occlusive dressing. The exposure
periods were 3 minutes, 1 hour and 4 hours, respectively. Skin reactions
were assessed up to 4 hours after the 3-minute exposure. Based on severe
skin reactions, no further animals were exposed to the test substance.
A 3-minute exposure to 0.5 g of Oleyl
tripropylenetetramine resulted in very slight erythema at 1 and 4 hours
A 1-hour exposure resulted in very slight
erythema immediately after exposure and in well defined erythema at 3
hours after exposure.
A 4-hour exposure resulted in dark brown
discolouration surrounded by grey discolouration at the edge of the
application area (sign of necrosis) immediately after exposure.
Sticky or dry remnants of the test substance
were present on the skin after exposure.
The dark brown discolouration surrounded by
grey discolouration at the edge of the application area are signs of
necrosis. Following this observation, the animal was sacrificed for
humane reasons. These severe skin reactions are expected to result in
deep and thick scab formation with possible ruptures of the scab, or the
scab may drop off exposing scar tissue. Overall, these skin reactions
were considered evidence of full thickness destruction of the skin, and
hence no further animals were tested.
Based on these results and according to the:
- Globally Harmonized System of
Classification and Labeling of Chemicals (GHS) of the United Nations
(2007), Oleyl tripropylenetetramine should be classified as : skin
corrosive (Category 1C).
- Regulation (EC) No 1272/2008 on
classification, labeling and packaging of substances and mixtures, Oleyl
tripropylenetetramine should be classified as Corrosive (Category 1C)
and labeled as H314: Causes severe skin burns and eye damage.
There are two studies available that
evaluated tallow tripropylenetetraamine for dermal irritation/corrosion
in in vivo rabbit studies.
Tallow tripropylenetetraamine was evaluated
for dermal corrosion in a standard OECD 404 study (SafePharm, 116/3
,1987). A three minute, 1 hour and 4 hours, semi-occluded dermal
application of the test material to the intact skin of three rabbits,
resulted to maximum scores for erythema in
all animals during first 3 days and in two animals accompanied by eschar
formation even until day 7, with desquamation in all three animals. At
end of observation period on day 14, all animals show pink and shiny
skin. In two animals desquamation was still visible. Although the report
indicates no visible necrosis, the seriousness of the effects, only
partial recovery, and pink shiny colouration indicative of skin recovery
after damage, makes it probably prudent to classify as corrosive. (Cat.
In a second study Tallow
tripropylenetetraamine was also evaluated for dermal corrosion following
standard guidelines (CIT, 1897 TAL, 1986): 3 rabbits were
exposed for 3 minutes and a further three rabbits were exposed for 1
hour. After the exposure period, excess material was wiped off with
Results: One hour
after exposure are signs of dermal irritation very weak in the animals
exposed for 3 minutes, and moderate in the others. After 24 hours were
reactions increased in both groups.
concludes that the substance is corrosive following 1 hour application.
However, the effects of corrosion are not
conclusive. Specifically, no ulcers, bleeding or bloody scabs were
observed in any of the animals. Only 'top necrosis' is mentioned for one
animal with crusts visible until day 9, after which all effects had
serious skin effects observed after one hour exposure, for which
classification as corrosive is disputable, it is prudent to certainly
assume corrosion following a four times longer exposure of 4 hours.
evaluation of dermal corrosion/irritation for REACH substances of
various categories of Fatty amines have recently been tested. Available
data and practical experience indicated that these substances are
corrosive to the skin. However, the information was generally
incomplete, often inconsistent and of low validity. For support in the
dossiers it was considered to perform the recommended in vitro dermal
corrosion studies using human epidermal skin constructs to have adequate
endpoint coverage. By comparing the more objective results from these
studies, they were thought to be useful to demonstrate classification,
in the support of the categories, and for inter- and extrapolation for
the studies performed, including with the polyamine products, indicated
that these substances are NOT corrosive in these in vitro test
systems using human epidermis constructs, showing viability scores after
3 minutes and 1 hour not much different from controls (The
study on Tallow tripropylenetetraamine itself was not possible as the
substance could not be removed from the skin. Notox,
491242, 2009). Also for other fatty nitrile derivatives the same
results were obtained.
To evaluate the
validity of the in vitro test systems for these substance a few
further studies were performed to validate the results with in vivo studies.
polyamines, the substance which was considered likely to have the least
corrosive properties was selected for an in vivo confirmatory
study. As experience (eg. from primary fatty amines, but also indicated
by comparing cytotoxicity scores from genotoxicity studies with the
various polyamines) indicate that corrosivity diminishes with increasing
alkyl chain length, the substance oleyl tripropylene tetramine was
selected, as this has the largest alkyl chain.
related Oleyl dipropylenetriamine was evaluated in an in vivo dermal
irritation/corrosion study in rabbits (NOTOX, 491219, 2010).
Exposure of the skin of one animal for 4 hours with oleyl
dipropylenetriamine resulted to evidence of full thickness destruction
of the skin, and hence no further animals were tested. It was concluded
that Oleyl tripropylenetetramine should be classified as skin corrosive
In the interest of animal welfare and
to minimize any testing likely to produce severe responses in animals,
it was decided not to perform further in vivo corrosion studies
in rabbits to confirm their corrosive properties.
available data on dermal corrosion for polyamines:
dipropylene triamine (branched)
Based on FA:
Skin corrosion –viabilityin vitro:3 min1 hour
Skin corrosion –
Corr. 1B(3 min)
(In vitro dermal
corrosion: Results considered corrosive when viability is below 50%
following 3 minutes, or below 15% following 1 hour exposure)
of the substances reached a viability indicating corrosion following 1
hour exposure, even in a case where in vivo results show
corrosion following only 3 minutes exposure.Although
in that case the 3 -minute exposure showed a viability below 50% thus
mode of action follow from their structure, consisting of an apolar
fatty acid chain and a polar end of a primary amine (linked to one or
two secondary amine). The structure can disrupt the cytoplasmatic
membrane, leading to lyses of the cell content and consequently the
death of the cell.
The similar physicochemical properties
among the group of polyamines, also suggest similar behavior and
toxicological responses for these substances.
A study was performed to assess the effects
of four different decontamination procedures on the irritancy potential
of the test material to the skin of the New Zealand White rabbit (SafePharm,
116/10, 1987). These procedures consisted of gentle swabbing with
cotton wool soaked in:
a) distilled water
b) distilled water & buttermilk soap
followed by distilled water only
c) 3% (v/v) aqueous acetic acid followed by
cotton wool soaked in distilled water only
A single, three minute, semi-occluded dermal
application of the test material to the intact skin of three rabbits
followed by these decontamination procedures produced different
is no information available regarding the threshold concentration for
dermal irritation for Tallow
dipropylene triamine. For a
structurally related dodecane branched dipropylene triamine a threshold
is indicated in a report of a Buehler test in Guinea pigs for dermal
sensitisation [Huntington, 1996, Report No.: LZA 129/953059/SS,
N-(3-aminopropyl)-Ndodecylpropane-1,3-diamine Skin sensitisation in the
Guinea pig - study not included in this dossier]. A preliminary
irritation study evaluated irritation from epidermal exposures to the
substance at various concentrations in distilled water for 6 hrs under
occlusion. The highest non-irritating concentration for epidermal
exposures was established at 0.5%. Epidermal concentrations of 1%
resulted to incidental irritation, and 5% resulted to necrotic patches
in all animals. Considering that this substance is the most corrosive
substance from the group of polyamines, this value can be used as worst
case threshold concentration for the whole group of polyamines.
to eyes is assumed for substances for which dermal corrosion has been
There are two studies available that
evaluated tallow tripropylenetetraamine for dermal irritation/corrosion
in in vivo rabbit studies. Both studies show some indication of
corrosive properties to the skin, but are not completely clear.
Additionally, for tallow
tripropylenetetraamine read across is applied to the structural
comparable Oleyl tripropylenetetraamine. As this substance is considered
to represent the substance of the group of polyamines with probably the
least corrosive properties, the positive corrosive results from the in
vivo dermal irritation/corrosion study in rabbits with this substance
indicates that all polyamines should be considered corrosive to the skin
Based on the available information, it
is concluded that tallow tripropylenetetraamine should be classified as
corrosive (Cat.1C) under GHS.
Corrosive to eyes is assumed for
substances for which dermal corrosion has been established.
There is no information is available
following exposure via inhalation. However, with a vapour pressure less
than 4.7 x 10-5 Pa at 20°C, potential for inhalation of vapours is
limited. Also the use of this substance will not result in aerosols,
particles or droplets of an inhalable size, so exposure to humans via
the inhalation route will be unlikely to occur. Consequently, despite
the irritant nature of the substance, respiratory irritation is not
expected, and classification STOT-SE Cat.3 for respiratory irritation is
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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