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EC number: 213-834-7 | CAS number: 1025-15-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
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- Specific investigations
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
28 days oral NOAEL (male rat): 15 mg/kg bw/day
28 days oral LOAEL (male rat): 50 mg/kg bw/day
28 days oral NOAEL (female rat): ≥50 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 15 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
In a GLP guideline study according to OECD guideline 407 rats (6 per sex and dose) were administered triallyl isocyanurate via gavage at concentrations of 5, 15 and 50 mg/kg bw/day for 28 days (2003-0756-FGT). An additional satellite group of 12 rats (6 per sex and dose) in the control, mid and high dose group for observation of reversibility, persistence or delayed occurrence of toxic effects were included for 14 days post treatment.
All animals survived to the end of the study and no test substance
related effects were observed in clinical signs. Suppressed body weight
gain was observed in males and females of the 50 mg/kg bw/day group.
Decreased food consumption was noted in males of the 50 mg/kg group from
day 21 to day 28 of administration. Haematological examination did not
show any substance-related differences between control and treated
animals. Acidification of urine was observed in males of the 50 mg/kg
bw/day dose group at the end of the exposure period. Blood chemistry
examination revealed increase in ASAT, ALAT and LDH, and decrease in
inorganic phosphorus in males of the 50 mg/kg bw/day group, increase in
AlP in females of the high dose group, and increase in total cholesterol
and phospholipid in males and females of the 50 mg/kg bw/day group.
Pathological examinations in animals sacrificed on day 29 revealed
increases in liver weight in males and females of the 50 mg/kg bw/day
group, and dark red discoloration of the liver in males of the high dose
group. Hypertrophy of central hepatocytes in males of the 5 and 15 mg/kg
bw/day groups and in males and females of the 50 mg/kg bw/day group were
found at histopathological examination of livers. In addition, single
cell necrosis of hepatocytes was observed in males of the 50 mg/kg
bw/day group, vacuolation of central hepatocytes in males of the 5 and
50 mg/kg bw/day groups, bile thrombi and pericholangitis in males and
females of the 50 mg/kg bw/day group, and hypertrophy of bile duct cells
in males in the 50 mg/kg bw/day group.
During recovery period a significant body weight gain increase was
observed in male and female rats, which received 50 mg/kg bw/day for 28
days. Thus, after the recovery period, the changes observed in body
weight were no longer observed. In addition 15 days after the end of
treatment there were no longer any differences between control and
treated animals regardingfood consumption, urinalysis, blood chemistry
parameters and necropsy. A significant increase in relative liver weight
in females of the high dose group was still present after the recovery
period. However this increase was to a less extent compared to the
degree after the end of the treatment period. In females of the high
dose group no longer any liver effect was noted after recovery period at
histopathology. In addition single cell necrosis and vacuolation of
central hepatocytes were no longer observed in male rats. For the change
in hypertrophy of central hepatocytes, bile thrombus, pericholangitis
and hypertrophy of bile duct cells the frequency or degree was reduced.
Hypertrophy of central hepatocytes, pericholangitis and hypertrophy in
bile ductal cell was found each in 3 males of the 50 mg/kg bw/day group.
Bile thrombus was noted in 5 males of the high dose group. Eosinophilic
inclusion bodies, seen in 2 males of the 15 mg/kg bw/day and in 4 males
of 50 mg/kg bw/day group and microgranulomas, which reflect restoration,
were found in the central region. Thus, based on these findings after
recovery period of 14 days reversibility of the changes was suggested.
The NOAEL is considered to be 15 mg/kg bw/day for males based on the significant histopathological changes in the liver still present after recovery period in the 50 mg/kg bw/day group. A NOAEL of ≥50 mg/kg bw/day is applied for females due to no adverse effects observed after recovery period. The liver was identified as target organ.
The applied test concentrations in the 28-day study were based on the results of a pre-study in rats, in which concentrations of 17, 50, 150 and 450 mg triallyl isocyanurate/kg bw/day were administered for 14 days. Two males of the 150 mg/kg bw/day dose group died and five deaths occurred in females and males of the 450 mg/kg bw/day group. In the 50 mg/kg bw/day group increased liver weight was observed in both sexes. In males of the 50 mg/kg bw/day group, higher ASAT, ALAT and cholesterol values were determined. In females of the 50 mg/kg bw/day group, lower haematocrit values, higher ALAT and higher cholesterol values were found.
In another subacute study similar to OECD guideline 407 rats (10 per sex and dose) received triallyl isocyanurate by oral gavage administration in concentrations of 1, 10 and 100 mg/kg bw/day (Komsta et al., 1989). Biochemical and haematological parameters as well as histopathological changes were evaluated after 14 days of dosing. In the high dose group 3 males and 2 females were killed for human reasons after 10 or 11 doses. Significantly suppressed body weight in males and females of the 100 mg/kg bw/day group was observed. No clinical signs, no changes in haematological parameters and no induction of liver mixed function oxidases were noted in any of the dose groups. Affected clinical parameters in the high dose group were decreased alkaline phosphatase, decreased glucose, potassium, calcium, inorganic phosphorus and uric acid levels as well as increased bilirubin and sorbitol dehydrogenase activity. Pathology revealed spleen, lymph nodes, thymus and kidney as the targt organs. Increased liver and kidney weights and decreased spleen weights were oberved in males receiving 100 mg triallyl isocyanurate/kg bw/day. All males and one female of the high dose group had smaller spleens and occasionally dark liver and kidneys. The spleen in the animals sacrificed before study termination were also smaller in size and the kidneys in one of the males were darker. Moderate to severe thymic atrophy was observed, which was more prominent in male animals. Males also revealed moderate to severe atrophy of the mesenteric lymph nodes and mild to moderate renal tubular degenerative changes. Follicular and mantle zone atrophy was observed in the spleen and was more prominent in male animals.
Since toxic effects were restricted to the high dose group animals, the NOAEL was determined to be 10 mg/kg bw/day for males and females, respectively. However in general, the changes induced by triallyl isocyanurate were in general more severe in males than in females.
In a not-reliable publication by Bidnenko (1969) rats (6 per dose) were administered daily triallyl isocyanurate at 1/5, 1/10 and 1/20 of the LD50 (corresponding to approx. 35, 70 and 140 mg/kg bw/day) for three months. The author reported death of 5 of 6 animals applied 1/5 of the LD50 and decreased body weight in the treated rats. No further information was provided.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Justification for classification or non-classification
The available data on repeated oral toxicity of the test substance meet the criteria for classification as "STOT RE 2, H373" according to Regulation (EC) 1272/2008 and as "Xn (R48/22)" according to Directive 67/548/EEC.
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