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EC number: 219-941-5
CAS number: 2579-20-6
- Oral LD50, rats - LD50 between 300 and 2000 mg/kg. LD50 reported as
- Dermal LD50, rabbits - LD50 = 1700 mg/kg.
LD50 values of 1,3-BAC to rats under the condition that undiluted
1,3-BAC is orally administered to the rats of 105 ± 3.7g and 88 ± 3.9g
in body weight ± standard deviation. Male 0.74 ml/kg (0.65-0.82 ml/kg,
P=0.05) or 700 mg/kg (610-770 mg/kg, P=0.05) Female: 0.83 ml/kg
(0.71-0.94 ml/kg, P=0.05) or 780 mg/kg (670-890 mg/kg, P=0.05).
A study was performed to assess the acute oral toxicity of the test
material in the Sprague-Dawley CD strain rat. The method followed that
in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral
Toxicity" (adopted 24 February 1987) and Method B1 of Commission
Directive 92/69/EEC (which constitues Annex V of Council Directive
Following a range-finding study, a group of ten fasted animals (five
males and five females) was given a single oral dose of test material as
a solution in distilled water at a dose level of 200 mg/kg bodyweight.
The animals were observed for fourteen days after the day of dosing and
were then killed and subjected to gross pathological examination.
There were no deaths. Clinical signs of toxicity noted in two females
were hunched posture and/or noisy respiration. No other signs of
toxicity were noted.
All animals showed expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material in the
Sprague-Dawley CD strain rat was found to be greater than 200 mg/kg
bodyweight but less than 2000 mg/kg bodyweight. This supports the
findings of the key study (Kashima Labs, 2007).
An acute dermal toxicity study was conducted by Huntingdon Research
Centre, registered in Maryland, USA, on behalf of Sherwin-Williams
Chemicals, Ohio, USA, to determine the acute toxic effects by dermal
exposure of the test substance 1,3 -Bis Aminomethyl Cyclohexane.
Four groups of two rabbits with unabraded skin and two with abraded skin
were exposed to the test material for a period of 24 hours, then the
dressing removed and the exposure site washed. Dose levels assessed were
1260, 1580, 2000, and 2510 mg/kg. The exposure sites were observed for
signs of skin reactions at 24 hours, and daily thereafter for 14 days.
Animals were observed for clinical signs and mortality for 14 days.
After 24 hours of exposure, all rabbits (intact and abraded) exhibited
severe erythema and edema. Within a few days, the edema subsided and the
skin became "leathery" in appearance and to the touch. All surviving
rabbits tended to lose weight during the 14-day post-exposure period.
All rabbits died at the 2510 mg/kg level, 2/4 rabbits died at each of
the 2000 and 1580 mg/kg levels, and all rabbits at the 1260 mg/kg level
survived until the end of the 14 -day observation period.
The dermal LD50 was calculated to be 1700 mg/kg of body weight.
Acute oral toxicity:
Three studies are available regarding the assessment of
acute oral toxicity of the test substance,
1,3-Bis(aminomethyl)cyclohexane; one study performed in 2007, one in
1998, and a further study in 1980. The studies
performed in 2007 and 1998 are considered reliable, both having been
performed according to recognised test guidelines, and in compliance
with GLP. The reliability of the third study (1980)
could not be assessed as only a limited report was available, and the
level of detail in the report is insufficient to determine reliability. In
each of the 2007 and 1998 studies, 100% mortality was seen at 2000
mg/kg, and no mortality was seen at 300 mg/kg and 200 mg/kg,
respectively. Each of these results is adequate for
classification purposes, however as neither study report concluded an LD50value,
the value reported in the third (1980) study for the acute oral LD50(700
mg/kg for males) in rats will be used.
It was noted that when the effect of the test material
administered as neat substance was compared to the effect when
administered as a formulation (i.e. a diluted form), the neat material
caused more severe toxic effects and resulted in a lower LD50than
when administered in a diluted formulation. As this effect was only
noted in the preliminary test of the 1998 study, and only tentatively
explored in the 1980 study (test material was administered to mice as a
formulation as it could not be accurately dosed as pure substance,
however one group was dosed with pure substance for comparison), the
effect was not accurately quantified.
Acute dermal toxicity:
An acute dermal toxicity study was conducted to determine
the acute toxic effects by dermal exposure of the test substance 1,3
-Bis Aminomethyl Cyclohexane.
Four groups of two rabbits with unabraded skin and two
with abraded skin were exposed to the test material for a period of 24
hours, then the dressing removed and the exposure site washed. Dose
levels assessed were between 1260 and 2510 mg/kg. The exposure sites
were observed for signs of skin reactions at 24 hours, and daily
thereafter for 14 days. Animals were observed for clinical signs and
mortality for 14 days.
After 24 hours of exposure, all rabbits (intact and
abraded) exhibited severe erythema and edema. Within a few days, the
edema subsided and the skin became "leathery" in appearance and to the
touch. All surviving rabbits tended to lose weight during the 14-day
post-exposure period. All rabbits died at the 2510 mg/kg level, 2/4
rabbits died at each of the 2000 and 1580 mg/kg levels, and all rabbits
at the 1260 mg/kg level survived until the end of the 14 -day
The dermal LD50was calculated to be 1700 mg/kg
of body weight.
It was noted that the acute dermal toxicity study
described above would not generally be considered sufficiently reliable
for use as a key study (it was judged to be a Klimisch score 3 for
reliability), however as the material is classified is corrosive (note
results in section 7.3), testing for acute dermal or acute inhalation
toxicity would not generally need to be conducted (as stated in Annex
VIII of the REACH regulation). On this basis, additional testing for
acute toxicity by inhalation or by dermal route would not be
recommended, and the result from the Huntingdon Research Centre study
will be used for classification purposes, and for the calculation of the
Justification for selection of acute toxicity –
Although the nominated study (1980) was not as reliable as the other
available studies (2007 and 1998), the 2007 and 1998 studies did not
conclude an exact value for the LD50 (rather, a range was indicated for
each study). The value for the LD50 concluded in the 1980 study is
consistent with the conclusions of the other two studies; on this basis
the LD50 value in rats is used as the dose descriptor for the CSA.
Each of three acute oral toxicity studies in rats concluded that the
LD50 value was in the range 200 - 2000 mg/kg, and two of these studies
confirmed that the LD50 value was in the range 300 - 2000 mg/kg.
According to the GHS system (EC Regulation 1272/2008 used for the
purposes of this classification), the substance should be classified as
acute oral toxicity category 4.
The acute dermal toxicity was assessed and the LD50 value was found to
be 1700 mg/kg. On this basis, the test substance should be classified as
acute dermal toxicity category 4 according to GHS (as described in EC
With respect to classification for Specfic Target Organ Toxicity
following a Single Exposure (STOT SE), treatment-related effects were
observed at necropsy in the stomachs of rats treated orally with the
substance at 2000 mg/kg (Kashima Labs, 2007). It was noted that the
level at which these effects were observed was lethal to all tested
animals; no such effects were seen at the next lowest dose level (300
mg/kg). As it cannot be confirmed that these effects occur at sub-lethal
doses it is considered that the substance does not meet the criteria for
classification as STOT SE. It is considered likely that the effects seen
in the stomach of the deceased animals is related to the effect causing
the mortality, for which the substance has been classified as acute
category 4, as noted above.
It was noted that sub-lethal effects (oedema and erythema, followed by
"leathery" appearance of the skin following the subsidance of the oedema
and erythema) were seen in all animals dosed in the Acute Dermal
Toxicity study. It is considered that these effects are due to the
corrosive nature of the substance; because 1,3-BAC is already classified
for Skin Corrosion (please refer to dossier section 7.3) a supplementary
classification for specific target organ toxicity following a single
dermal exposure (STOT SE, dermal route) is not justified.
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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