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EC number: 202-936-7
CAS number: 101-37-1
Workers might be exposed to triallyl cyanurate (liquid or vapour)
during manufacture, processing or filling in appropriate containers.
During formulation, triallyl cyanurate-coated silica particles
containing 50 or 70 % TAC are obtained. Exposure may occur to liquid
triallyl cyanurate or the vapour; however, the predominant relevant way
of exposure is via triallyl cyanurate-coated silica particles.
Since no usable dose descriptors for the dermal and inhalation
exposure route are available, the only usable dose descriptor (oral
route) to derive long-term DNELs, the dermal as well as inhalation
DNELs, regarding acute and long-term effects on workers were determined
using route-to-route extrapolation, according to the ECHA guidance
document "Guidance on information requirements and chemical safety
assessment. Chapter R.8: Characterisation of dose
[concentration]-response for human health", November 2012.
For the derivation of all relevant DNELs a NOAEL of 30 mg/kg
bw/day obtained in a 90-day gavage study in rats was used. The
establishment of an acute toxicity DNEL set for effects occurring after
a single exposure of a few minutes up to 24 hours is unnecessary for
TAC, as the long-term DNEL is sufficient to ensure, that these effects
do not occur. TAC has a very low vapour pressure at room temperature and
as a consequence, the formation of aerosols can be considered
negligible. Thus, peak exposure significantly higher than the average
daily exposure and the long-term DNEL are very unlikely. In addition
since TAC did not show any irritating effects, no DNELs for local
effects were derived. The assessment of hazards for acute systemic
effects and local effects are sufficiently covered by derivation of the
DNEL for long-term systemic exposure.
As starting point for derivation of the DNELs, a NOAEL of 30 mg/kg
bw/day (for systemic effects) was used which was found in a subchronic
toxicity study performed according to OECD 408 (2012-0288-DGT). In this
GLP guideline study TAC was administered via gavage at concentrations of
10, 30 and 120 mg/kg bw/day for 90 days. Additional satellite animals
for the control, mid and high dose group for observation of
reversibility, persistence or delayed occurrence of toxic effects were
included for 56 days post treatment. A NOAEL of 30 mg/kg/day was derived
based on the significant histopathological changes in the liver in male
rats dosed with 120 mg/kg bw/day at the end of the treatment period
(which have mainly subsided after the recovery period) and other
evidence of toxicity as clinical signs, reduced body weight, effects on
functional observational battery parameters, and increased liver weights
observed in both female and male animals dosed with 120 mg/kg bw/day.
Thus, the NOAEL value of 30 mg/kg bw/day was selected as relevant dose
To convert an oral NOAEL (in mg/kg bw/day) into a dermal NOAEL (in
mg/kg bw/day, the differences in absorption between routes as well as
differences in dermal absorption between rats and humans have to be
accounted for. According to QSAR predictions obtained from the Danish
(Q)SAR database (2009), gastrointestinal absorption is presumed to be
100%, whereas dermal uptake is predicted to be low (0.001 mg/cm2/event).
Based on this, a dermal uptake of 20% is assumed. No differences in
dermal absorption between rats and humans are presumed.
The conversion of the oral NOAEL into the dermal NOAEL is
performed using the following equation:
Corrected dermal NOAEL = oral NOAEL x ABS oral / ABS dermal
= 30 mg/kg bw/day x 100 / 20 = 150 mg/kg bw/day
Subsequently, the following assessment factors are taken into
account for the final DNEL calculation: interspecies differences (4),
remaining interspecies-differences (2.5), intraspecies differences (5)
and duration extrapolation: subchronic - chronic (2), resulting in an
overall assessment factor of 100.
As a consequence, the resulting DNEL for long-term dermal systemic
effects is 1.5 mg/kg bw/day for workers.
For calculation of the DNEL for long-term inhalative systemic
effects, the dose descriptor has to be converted into a corrected
starting point by route-to-route extrapolation. According to QSAR
predictions obtained from the Danish (Q)SAR database (2009),
gastrointestinal absorption is presumed to be 100 %. The inhalative
absorption is considered to be in the same order of magnitude as the
oral absorption. Therefore no additional factor is applied for
differences between the oral and inhalative intake.
The conversion of an oral NOAEL into an inhalation NOAEC is
performed using the following equation:
For workers (light activity):
Corrected inhalatory NOAEC = oralNOAEL x 1/sRVanimal x ABSoral /
ABS inhalation x sRVhuman / wRV
The standard respiratory volume for the 8 h exposure is 0.38 m3/kg
bw for rats and 6.7 m3 (per person) in humans. The default 8-h
respiratory volume of a worker is 10 m³ taking increased activity into
For a short-term scenario of 15 min exposure, different standard
parameters are used. The standard respiratory volume for the 15 min
exposure is 0.012 m3/kg bw for rats and 0.21 m3 in humans. The default
15 min respiratory volume of a worker is 0.3125 m³.
This results in the following equations:
For 8 h exposure:
Corrected inhalatory NOAEC = oralNOAEL x 1/0.38 m3/kg bw x 6.7 m3
/ 10 m3
For 15 min exposure:
Corrected inhalatory NOAEC = oralNOAEL x 1 / 0.012m3/kg x 0.21 m3
/ 0.3125 m3
Subsequently assessment factors (AF) are listed, which have to be
taken into account for the final DNEL calculation: remaining
interspecies-differences (2.5), intraspecies differences (5), duration
extrapolation: subchronic - chronic (2), resulting in an overall
assessment factor of 25 for long-term exposure and 12.5 for short-term
exposure (no duration extrapolation applied). The inhalative DNELs for
workers are calculated according to the formula DNEL = (corrected
starting point)/(overall AF). Thus, the resulting DNEL for long-term
inhalative systemic effects is 2.12 mg/m³ and the resulting DNEL for
short-term inhalative systemic effects is 134.4 mg/m³.
Since exposure for the general public is precluded,
DNELs for the general population are not relevant and thus not derived.
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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