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EC number: 239-701-3
CAS number: 15625-89-5
are valid study data available to assess the acute oral, dermal and
inhalation toxicity of trimethylolpropane triacrylate (TMPTA).
according to other protocols:
a BASF company study report (BASF 1980, Gelbke H. P.) TMPTA dissolved in
cellulose(10.0; 6.8; 4.6 and 3.2 g/kg bw) was administered
via gavages to 10 (5m; 5f) rats. Mortality, clinical signs and
bodyweight was examined 1h, 1d, 2d, 7d, 14d after application. In result
a LD50 of 3680 mg/kg bw was calculated after 14 days.
study was conducted to assess the single dose toxicity of
trimethylolpropane triacrylate (TMPTA) in Sprague-Dawley rats using the
standard acute method (Cytec, Bionetics, Hart E. R. 1972). Groups of 5
Sprague-Dawley rats/dose (sex unspecified) received a single oral
(gavage) dose of 50.0, 127.5, 315.1, 785, 1999, 5000 mg/kg TMPTA. The
three lower doses were administered as 10% suspensions stabilized by the
incorporation of 5% acacia, while the three higher doses were
administered undiluted. Parameters evaluated included survival and
clinical observations on the day of dosing and at least daily thereafter
for 14 d. No mortalities were observed except in two of the five animals
in the 5000 mg/kg bw group. In conclusion, the single oral median lethal
dose (LD50) TMPTA in rats was calculated to be > 5000 mg/kg bw.
both available studies indicate a LD50 above 2000 mg/kg bw only a low
degree of oral acute toxicity is expected.
the report of the BASF
study is written in German,the
used as supporting study. The well-conducted
documentation of the Bionetics study(1972a)assigns
this study as key study.
acute dermal toxicity of TMPTA was determined using 6 Sprague Dawley
rats (BASF 1981, Jäckh). All rats received a dosage of 2000mg/kg bw
applied on a 50cm2area on the shaved back/flank. After 24h exposure the
test item was removed. Observation was carried out for 14 days. One of
the used animals died on day 1 all other survived the treatment. General
intoxication symptoms could (apathy,dyspnoea,
bad general condition) be observed for some animals. Necropsy shows no
unusual findings for the surviving animals, whereas the early died
animal shows ulceration of the glandular stomach and acute dilation of
the heart chamber. Local findings like redness and oedema could be
observed for all treated animals. Based on this study the mean lethal
dose for 14 days was determined as > 2000 mg/kg.
study was conducted to evaluate the acute dermal toxicity TMPTA in
rabbits (Cytec, Litton Bionetics 1972, Hart E. R.). Therefore, sixteen
albino rabbits were prepared by careful removal of the hair with
electric clippers. Planned areas of application were identified and in
half of the animals the area was lightly abraded. After weighing the
animal, the calculated dose was applied, and the entire area covered
with a rubber dam, held in place by tape. The dose levels applied were
0.315, 0.795, 1.99 and 5.0 mL/kg bw TMPTA. Four animals were included in
each dose group. 24 h later, the binders were removed, and an effort
made to remove any remaining material from the skin surface. A score of
the local effects, according to the method of Draize, was recorded. The
animals were observed repeatedly for seven days at the end of which time
they were killed, and necropsy was performed. One mortality was observed
at dose levels 1.99 and 5.0 mL/kg bw. In some cases, TMPTA caused no
erythema or oedema,
but in others caused severe effects. The author concludes that, the
single dermal median lethal dose (LD50) of TMPTA was determined to be
4.7 mL/kg bw (i. e. 5170 mg/kg bw) in rabbits.
both available studies indicate a LD50 above 2000 mg/kg bw no dermal
acute toxicity hazard is expected.
studies were well conducted and met general accepted scientific
principles. Both study results points to the same hazard range
the BASF study(1981)is
only available in German, the Cytec study(1972b)is
used as key study.
acute inhalations toxicity risk of TMPTA was determined with Sprague
Dawley rats according to H. F. Smyth et al: Am. Ind. Hyg. Ass. J. 213,
95-107 (1962) (BASF 1980, Klimisch H. J.). Therefore,rats
were exposed up to 7 h against a vapour pressure saturated test
atmosphere. In result,all
animals survived the highest exposure time (7h) without symptoms or
unusual section findings.
study was conducted to evaluate the acute inhalation toxicity TMPTA in
rats (Cytec, Industrial Bio-test 1976, Goode J. W.). Therefore 5rats/sex
were exposed to the vapour
of TMPTA at a single concentration of 0.55 mg/L air
(nominal) for 6 h followed by and observation period of 14 days. Body
weight was measured during the observation period and necropsy was
performed at the end of this period.
were no reactions noted during exposure or during the 14-day observation
period. The average body weight gains were within the normal limits.
Necropsy, performed on all rats at the end of the observation period,
did not reveal any gross pathologic alterations. In conclusion, the
single median lethal inhalation (LC50) of TMPTA was determined to be
greater than 0.55 mg/L after 6 h exposure in rats.
there was no increased in mortality found when TMPTA is applied to the
rodents at saturation concentration, no inhalation toxicity hazard
derives from vapour exposure from these study results.
studies were found to be satisfying to meet general scientific accepted
principles, but both were less in documentation and did not follow a
guideline. The BASF study report(1980)is
only available in German and some important information are missing. But
both studies were used as information source. Nevertheless, as only,the
sufficient in documentation for risk assessment;values
deriving from this study are used for risk assessment.However,none
of the studies is used as key study.
following information is taken into account for any hazard / risk
oral toxicity, rats, company protocol: LD50 (oral, rat) = 3680 mg/kg bw
(BASF 1980, Gelbke, H. P.)
oral toxicity, rats, company protocol: LD50 (oral, rat) >5000 mg/kg bw
(Cytec, Bionetics, Hart E. R., 1972)
inhalation toxicity, rats, company protocol LC50 (inhalation, 6h, rat) >
0.55 mg/L (saturation) (Cytec, Industrial Bio-test 1976, Goode J. W.)
dermal toxicity, rats, company protocol: LD50 (dermal, rat) > 2000 mg/kg
bw (BASF 1981, Jäckh)
dermal toxicity, rabbits, company protocol: LD50 (dermal, rabbit) > 5170
mg/kg bw (Cytec, Litton Bionetics 1972, Hart E. R.)
data for TMPTA indicate a low acute toxic potential.
As the LD50
(rat) for acute oral toxicity and for acute dermal toxicity is
determined above 2000 mg/kg bw TMPTA has not to be classified as acute
dermal toxic or acute oral toxic according to GHS (Regulation (EU)
1272/2008) and also not to be classified according to DPD (67/548/EEC).
inhalation toxicity test reveals no deaths in the highest administered
concentration (LC0 = 0.55mg/L). This concentration reflects the maximum
vapour concentration (saturation concentration). Based on the physical
properties the maximum attainable concentration for the vapour is
reached therefore the substance has to not to be classified for acute
inhalation toxicity according to GHS (Regulation (EU) 1272/2008) and DPD
(67/548/EEC) based on the results of vapour inhalation.
for oral, inhalation and dermal toxicity:
GHS: Acute tox
5, H303 (May be harmful if swallowed)
1272008): no acute toxicity classification for any exposure route
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