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EC number: 202-486-1
CAS number: 96-18-4
not sensitising, (OECD TG 406, guinea pig maximisation test); study
Shell Development Company (1980C) / key (Hartley-Albino guinea pigs,
Buehler Test, OECD TG 406)
In the present study (Shell Developmental Company 1980C)
1,2,3-trichloropropane was tested for its skin sensitizing properties
using the Buehler Test with male and female Dunkin-Hartley guinea pigs
in general compliance to OECD TG 406 as at 1980. The test item was
tested at the highest non irritating concentration as derived from a
pretest (0.5 mL of neat test item) under occlusive conditions for 6 h
per exposure (3 induction exposures, 1 challenge exposure). None of the
animals in the test group showed a sensitization reaction, while the
positive test group (agent: 2,4-dinitro chlorobenzene) showed the
sensitivity of the test system. Based on this result
1,2,3-trichloropropane is not a skin sensitizer in this test system and
a classification for skin sensitization CLP (REGULATION (EC) No
1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as
implementation of UN-GHS in the EU is not necessary.
5 males and 5 females per group were clipped on the back 48 prior to
treatment and finally depilatated with Neet hair remover 24 h prior to
treatment. 4 groups were used: a "vehicle" control group (corn oil, even
though in the treatment groups the test material was applied undiluted),
a positive control group (agent: 2,4-dinitro chlorobenzene) and two test
groups - one for sensitization and one for irritation. The irritation
group and the "vehicle" control group were not treated with the test
item during the induction, while the two other groups were treated with
the respective substance on day 2, 9 and 26. Substances were applied to
patches which were placed laterally from the midline of the back on the
left front quadrant of the exposure areas with the gauze pads adjacent
to, but not overlapping, the midline of the backs. On day 30 the two
test groups were treated similarly with 1,2,3 -trichloropropane but on a
different site, laterally on the right rear quadrant. Positive and
negative controls were treated accordingly and all animals were scored
for skin reactions 24 and 48 h after challenge exposure using the Draize
- The classification of the key parameter is based on results of
the study Shell Development Company (1980C) / key (Hartley-Albino guinea
pigs, Buehler Test, OECD TG 406) considered to be fully reliable and
compliant to OECD TG 406 by the SIDS INITIAL ASSESSMENT REPORT For SIAM
18 - 1,2,3-Trichloropropane as at 2004. Shell Development Company
(1980C) / key (Hartley-Albino guinea pigs, Buehler Test, OECD TG 406).
In an additional study that is only available from a secondary source
this finding is confirmed (guinea pig maximisation test; Bio/dynamics
Inc. (1985), Buehler test). In Clark (1977, guinea pig maximisation
test) slight positive results were found. Nevertheless these effects
would not be sufficient for classification. Anyway the study is regarded
unreliable as the study was conducted with 1,2,3 -trichloropropane of a
purity of 92 % without any information on the nature of the impurities.
Therefore 1,2,3 -trichloropropane is deemed not to be a skin sensitizer
which is in-line with the current classification and labelling.
- No information on the sensitising potential of
1,2,3-trichloropropane via the inhalation route is available. As
1,2,3-trichloropropane is not a sensitizer via the dermal route the risk
that the substance is a respiratory sensitizer is regarded negligible.
- Based on the results presented above, 1,2,3 -chloropropane is
not a skin sensitizer and therefore does not need to be classified for
skin sensitization according to CLP as implementation of UN GHS in the
EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE
- No information on the sensitising potential of1,2,3
-chloropropane via the inhalation route is available. As 3-chloropropene
is not a sensitizer via the dermal route the risk that 3-chloropropene
is a respiratory sensitizer is regarded negligible. Based on this
reasoning 3 -chloropropene does not need to be classified for
respiratory sensitization according to CLP as implementation of UN GHS
in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL).
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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