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EC number: 239-622-4
CAS number: 15571-58-1
DNEL for Long term
The target organ identified
in oral repeated dose toxicity studies with DOTE is the thymus.
Reduction of thymus weight was observed at very low levels, this is the
reason why the substance DOTE is classified as T; R48/25 according to
Directive 67/548 and as STOT RE Cat 1 according to GHS for specific
Based on the available data
from recent OECD 414 studies conducted in both rabbits and mice
administering DOTE via the oral route, no teratogenic or foetotoxic
effects were seen. In other existing studies, no reprotoxic effects were
seen at dosages lower than the thymus effects in the repeated dose
The main critical effect
identified was therefore that on the thymus and this was subsequently
considered to be the appropriate effect for which to calculate DNELs
when using the results of the toxicology studies.
For workers, it was
considered appropriate to use the recently updated MAK values to derive
the no effect level.
inhalation, systemic toxicity
A MAK-value is available for
n-octyltin compounds. MAK-value is "the biggest amount of
health-damaging gases and fumes, volatile or floating materials that can
still be born without health damage during working hours (8 hours) at
This MAK value is equal to
0.0098 mg Sn/m3.(following
update in 2012)
Forschungsgemeinschaft - Commission for the Investigation of Health
Hazards of Chemical Compounds in the Work Area - Report No. 48 2012
Molecular weight of Sn =
Molecular weight of DOTE =
DOTE = 15.8% Sn
MAK-value = 0.0098 x 100 /
15.8 = 0.062 mg/m3
DNEL (Inhalation long term, systemic effects)=
Occupational exposure to
DOTE may also occur by dermal exposure. Although no dermal repeated dose
toxicity studies is available a dermal DNEL was derived based on the
Step 1) Relevant
= 0.062 mg/m3.
This value is calculated for
workers for a chronic exposure of 8 hours per day, and 5 days per week.
2) Modification of starting point:
Calculation of internal dose =
0.062 x 10* = 0.62 mg/person
0.62 / 70 = 0.0089 mg/kg bw
Calculation of external dose
(dermal) = 0.0089 x 100/0.004**= 222.5 mg/kg bw/d
* Respiratory volume of workers
**Correction for inhalation
and dermal absorptions:
default absorption of 100%
Anin vitroabsorption study though human and rat epidermis was
performed (Ward 2003) and indicated very low absorption of tins through
rat (0.004%). We consider that dermal absorption is the same in human
and in rat.
Step 3) Assessment factors
intraspecies : none, because the MAK value is calculated for workers.
Exposure duration : none,
because the MAK value is calculated for chronic exposure.
No assessment factor is
2. GENERAL POPULATION
2.3 Long-term, oral,
Of the available long-term
studies (All conducted in the rat) the13
week repeated dose toxicity study (performed in 1970 in equivalence to
OECD 408) is selected as the starting point for DNEL derivation. Of
the available studies this is noted to have been performed using the
highest purity of the registered substance, is dosed over the longest
duration and also yields the lowest NOAEL with regards to effects on the
thymus (the critical target), acting as a precautionary measure with
regards to the establishment of the DNEL.
1) Relevant dose-descriptor
NOAEL, rats=(long term
toxicity - effects on the thymus) =10 ppm, equivalent to0.5
2) Modification of starting point:No
3) Assessment factors
-Interspecies: 2.5 x 4
(allometric scaling) = 10
-Intraspecies : 10 (general
-Exposure duration : 2
-Dose response: 1
-Quality of database:2
(the DNELs are based on older, non GLP studies whilst the OECD 414
studies are not yet finalised)
Total safety factor = 400
DNEL Value based on the
NOAEL in the 90 day repeated dose toxicity study (Anonymous 1970) :
General Pop DNEL (oral,
long term, systemic)= 0.5 / 400 = 0.00125 mg/kg bw/d
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