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EC number: 219-941-5
CAS number: 2579-20-6
Toxicokinetic assessment for 1,3-cyclohexanedimethanamine
This assessment of the absorption, distribution, metabolism and
excretion of 1,3-cyclohexanedimethanamine is derived from data produced
for its notification under the requirements of EC Regulation 1907/2006
and represents the Toxicokinetic assessment under Annex VIII of the
Identity and physico-chemical parameters
Acute oral toxicity – No mortality seen at 300 mg/kg; 100% mortality
seen at 2000 mg/kg. LD50estimated
at 700 mg/kg. In key study, no clinical signs
were seen in 300 mg/kg dose group; at 2000 mg/kg decreases in
locomotor activity and irregular respiration were seen from
10 minutes after the administration. One
animal was found dead within 6 hours of the administration, and two
animals showed hypothermia and died the day following administration. No
gross pathological findings were recorded in the 300 mg/kg group. In
all animals which died, reddish change and oedema were noted in the
forestomach and glandular stomach, and abnormal contents were
observed in the stomach and intestine. Moreover,
reddish ascites was noted in the abdominal cavity of the animal
found dead on the day of administration.
Acute dermal toxicity – LD50calculated to be
1700 mg/kg. 2 out of four rabbits died at
each of 2000 mg/kg and 1580 mg/kg dose levels, no mortality was seen
at 1260 mg/kg. Bodyweights were seen to
decrease in animals exposed above 1580 mg/kg. Gross
pathological findings were not remarkable in the survivors
necropsied 14 days after administration. Advanced
autolysis prevented pathological examination in those animals found
dead during the study.
Skin corrosivity / irritation – corrosive effects were seen in
rabbits following a 3-minute dermal exposure. Necrosis
of the application site was observed 1 hour after exposure.
Skin sensitisation – no sensitisation (0/10 animals) seen in guinea
Repeated dose toxicity, oral – OECD 422 Combined repeated dose
toxicity with reproductive / developmental toxicity screening test
(rats); NOEL = 60 mg/kg/day. One male animal
died at 300 mg/kg/day, with loss of locomotor activity seen before
death. Salivation was periodically observed in the
300 mg/kg/day dose group throughout the administration period. No
test substance-related changes in behaviour, sensory reactivity, or
motor activity were noted between the control group and treated
groups throughout the study. Body weight gain was
Gene mutation (in-vitro) – Test substance was found to have been
cytotoxic in a bacterial reverse mutation assay, however no
genotoxicity / mutagenic activity was seen in four strains of
Salmonella typhimurium or one strain of Escherichia coli, either
with or without metabolic activation. The test
substance showed the potential to induce chromosomal aberrations in
Chinese Hamster Lung cells (tested in-vitro) in the absence of
metabolic activation, although no chromosomal aberrations were seen
under the same conditions in the presence of metabolic activation.
Gene mutation (in-vivo) – The test substance did not show evidence
of having increased the induction of micronucleated polychromatic
erythrocytes in mice in vivo.
Substance has high pH and has observed corrosivity. The
substance acts quickly on dermal tissue It is likely that this substance
is highly absorbed no matter the exposure route. It
has been shown to have significant effects on the gut and in acute
studies, one animal died within 6 hours of dosing. In a repeat
dose study, it was demonstrated that there was evidence of absorption.
For example, at the high dose level (300 mg/kg/day), a male died, there
was suppression of bodyweight gain, and there were effects in the testes
(atrophy of seminiferous tubules). The findings in the stomach were
associated with the known irritant/corrosive nature of the test
However, local effects may be more prominent (especially since corrosion
is the major mechanism of action). Systemic effects
were also observed upon dermal exposure as 50% mortality was seen at the
highest dose levels.
Inhalation toxicity was not assessed due to the substance’s affect on
dermal membranes. It can be expected that sensitive lung tissue would
also experience corrosion and therefore these tests are not necessary.
Metabolism, Distribution and Elimination
Due to the speed at which effects have been observed in acute studies,
metabolic activation is unlikely needed for substance to cause toxicity.
In the repeat dose study in rats, at the end of the two week
recovery period, there was evidence of recovery or at least partial
recovery. This indicates that there is fairly rapid elimination of the
test material and consequent amelioration of the physical
(irritation/corrosive activity) and systemic toxic effects.
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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