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International Journal of Toxicology 43(Supplement 1)
Table 2. (continued)
Test Substance
Isodecyl Alcohol
Isotridecan-1-ol
Summary Data
single dose (acute) toxicity-dermal: LD50 of a mixture of C9-11 branched alkyl alcohols in rats, >2600 mg/kg
single dose (acute) toxicity-oral: LD50 of a mixture of C9-11 branched alkyl alcohols in rats, 4600 mg/kg
reproductive and developmental toxicity: a mixture of C9-11, branched alkyl alcohols had a maternal NOAEL of 158 mg/
kg bw and a fetal NOAEL of 790 mg/kg bw in an oral (gavage) developmental toxicity study in rats
single dose (acute) toxicity -dermal: LD50 in rabbits, >2600 mg/kg bw (24-h occlusive patch)
single dose (acute) toxicity - oral: oral (gavage) LD50 >2000 mg/kg in male and female Wistar rats and >17.2 mL/kg bw in
male Carworth Wistar rats
single dose (acute) inhalation toxicity: LC0 >.3 mg/L (8 h) in male and female rats
genotoxicity: not genotoxic in an Ames test (20-5000 µg/plate, with or without metabolic activation)
dermal irritation - non-human: 4-h semi-occlusive patches and occlusive patches with undiluted test material applied for
1-15 min or 20 h were irritating to rabbit skin
sensitization - non-human: not a sensitizer in guinea pigs(n=20), with 1% and 5% for intradermal and topical induction,
respectively, and .1% used at challenge
ocular irritation: instillation of .05 mL (n=2) or .1 mL (n=3) undiluted test material into rabbit eyes for 24 h was classified
as not irritating
Tridecyl Alcohol
single dose (acute) toxicity-dermal: dermal LD50 in rabbits, 5600 mg/kg
single dose (acute) toxicity-oral: oral LD50 in rats, 17,200 mg/kg
7
Abbreviations: CHO, Chinese hamster ovary; GI, gastrointestinal; LOAEL, lowest observable adverse effect level; NOAEC, no-observable adverse effect
concentration; NOAEL, no observed adverse effect level; NOEL, no-observed effect level; NZW, New Zealand White.
8
Reference
4
Figure 1. Trimellitic acid.
Figure 2. Trialkyl trimellitates, wherein R is the alkyl residue of a
fatty alcohol.
di-(2-ethylhexyl)terephthalate; the amount of this impurity
present in the test material was not specified.2
Use
Cosmetic
The safety ofthe cosmetic ingredients included in this assessment
is evaluated on the basis of the reported use in cosmetics. The
Panel utilizes data received from the US Food and Drug Administration
(FDA) and from the cosmetics industry in determining
safety based on the expected cosmetic use. The data
received from the FDA are those collected frommanufacturers on
the use ofindividual ingredients in cosmetics by product category
in its Voluntary Cosmetic Registration Program (VCRP). Data
from the cosmetic industry are submitted in response to a survey
ofmaximum use concentration by product category conducted by
the Personal Care Products Council (Council).
Data obtained from the FDA VCRP in 201520 and submitted
by industry in response to the Council survey in 201421
indicate that 4 of the 5 ingredients included in this safety
assessment are used in cosmetic formulations; tricaprylyl/
capryl trimellitate is the only ingredient in this group that is
not reported to be used. Tridecyl trimellitate has the greatest
frequency and concentration ofuse; it is reported to be used in
409 formulations, and the maximum reported concentration of
use is 57.1% in lipstick formulations (Table 4).
The 5 trialkyl trimellitates named in this report are not restricted
from use in any way under the rules governing cosmetic
products in the European Union.22 In Australia, according to a
NICNAS report, tridecyl trimellitate cannot be classified according
to the Globally Harmonised Systemfor Classification
and Labelling of Chemicals or the Approved Criteria for
ClassifyingHazardous Substances because limited toxicity data
are available. However, it not considered to pose an unreasonable
risk to the health ofworkers, and when used at ≤40% in
foundation, lipstick, eye shadow, and eyeliner formulations
and ≤9% in hand and face creams, it is not considered to pose an
unreasonable risk to public health.9 (These concentrations were
provided to NICNAS as intended use concentrations).
Non-Cosmetic
Triethylhexyl trimellitate is a primary plasticizer used in
polyvinyl chloride (PVC) plastic.23 It has high temperature

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