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EC number: 485-420-6
CAS number: 182918-16-7
The potential for skin and eye irritation of the test substance was not assessed. Information on irritation are derived from a strucutral analogue. Two GLP and OECD guideline conform studies (OECD 404 and 405) in rabbits were conduceted to evaluate the irritating potential of the analogue. As a result, the analogue is not irritating to skin or eyes. Clinical signs or mortalities were not observed.
The irritation-potential of the test item (intermediate) was not
determined. There are reliable studies of an analogue substance (final
product) available to assess the potential for skin and eye irritation.
The toxicity profile of the analogue as well as of the test item is
determined by the main component; the side products (5 -6%) are
structural analogues of the main product without influence on substance
toxicity. Both substances share high similarity in structure, are poorly
soluble in water and have a logPow >8. It is, therefore acceptable to
derive information on skin and eye irritation from experimental data of
this read across substance. A detailed risk assessment and read across
justification was send to the german chemical agency BAuA in 2007 with
the purpose of a national substance notification (VIIA). The read across
justification was accepted by the national agency.
In a GLP conform study the primary skin irritation
potential of the analogue (purity: > 98 weight-%) was investigated by
topical semi-occlusive application of 0.5 g to the intact left flank of
each of three young adult New Zealand White rabbits (RCC Ltd, 2002). The
duration of treatment was four hours. The scoring of skin reactions was
performed 1, 24, 48 and 72 hours after removal of the dressing. The test
item did not elicit any skin reactions at the application site of any
animal at any of the observation times (all scores 0). The individual
mean score for erythema/eschar and oedema for each of the three animals
was therefore 0. The test item caused no staining of the treated skin.
No corrosive effects were noted on the treated skin of any animal at any
measuring interval. The test substance is considered to be "not
irritating" to rabbit skin.
In a GLP conform study the primary eye irritation potential of the
analogue (purity: > 98 weight-%) was investigated by instillation of 0.1
g into one eye of each of three young adult New Zealand White rabbits
(RCC Ltd, 2002). Scoring of irritation effects was performed
approximately 1, 24, 48 and 72 hours after test item application. The
scores of each animal at the following reading times (24, 48 and 72
hours) were used in calculating the respective mean values for each type
of lesion. The primary eye irritation score was calculated by totaling
the mean cumulative scores at 24, 48 and 72 hours and then dividing the
resulting total by the number of data points. The primary eye irritation
score was 0.33 (max. 13). The eye reactions (mean values from 24 to 72
hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions,
grade 0.33 redness of the conjunctivae and grade 0.00 chemosis of the
conjunctivae. The instillation of the test substance into the eye
resulted in mild, early-onset and transient ocular changes, such as
swelling and reddening of the conjunctivae and sclerae. These effects
were reversible and were no longer evident 72 hours after treatment, the
end of the observation period for all animals. No abnormal findings were
observed in the cornea or iris of any animal at any reading. No
corrosion was observed at any of the measuring intervals. No staining of
the treated eyes by the test item was observed. Thus, the test item did
not induce significant or irreversible damage to the rabbit eye. The
test substance is considered to be "not irritating" to the rabbit eye.
Dangerous Substance Directive
The available studies are considered
reliable and suitable for classification purposes under 67/548/EEC. As a
result the substance is not considered to be classified as irritating
for skin or eyes under Directive 67/548/EEC, as amended for the 30th
time in Directive 2008/58/EC.
Classification, Labelling, and
Packaging Regulation (EC) No. 1272/2008
The available experimental test data
are reliable and suitable for classification purposes under Regulation
1272/2008. As a result the substance is not considered to be classified
for irritation under Regulation (EC) No. 1272/2008, as amended for the
second time in Directive (EC 286/2011).
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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