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EC number: 264-140-6
CAS number: 63429-28-7
Skin irritation: irritating (similar to OECD 404, GLP, Read-across, WoE, rel. 2)Eye irritation: not irritating (similar to OECD 405, read-across, K, rel. 2)Respiratory irritation: no data available
7.3.2/1: Mean eye irritation response data of 6 animals at each
Score at time point / Reversibility
Average time for reversion
7.3.2/2: Eye irritation response data for each animal at each
Score at time
24 h (Day 1)
0 / 0 / 0 / 0 / 0 / 0
1 / 2 / 1 / 0 / 0 / 1
1 / 1 / 1 / 0 / 0 / 1
1 / 3 / 2 / 0 / 0 / 0
48 h (Day 2)
0 / 2 / 0 / 0 / 0 / 0
0 / 1 / 0 / 0 / 0 / 0
72 h (Day 3)
Average 24, 48 and 72 h
0.33 / 1.33 / 0.33 / 0 / 0 / 0.33
0.33 / 1 / 0.33 / 0 / 0 / 0.33
0.33 / 2.33 / 0.67 / 0 / 0 / 0
Average time (unit) for reversion
an eye irritation study, 0.1 g of undiluted test material was instilled
into the right eye of 6 albino rabbits while the left eye remained
untreated and served as control. The eyes were not rinsed after the
instillation of test material. Animals were observed at 24, 48 and 72 h
after instillation of test material into eyes and then on Days 5 and 7.
The reactions in the conjunctivae (redness, chemosis and discharge), the
iris and the cornea (opacity and area involved) were scored according to
the “Illustrated guide for grading eye irritation by hazardous
calculated mean score for each animal within 3 scoring times (24, 48 and
72 h) were 0.39 for redness, 0.33 for chemosis, 0.0 for iris lesions and
0.0 for corneal opacity. The observed conjunctival reactions were fully
reversible within 5 days.
the test conditions, the test material is not classified as irritating
to the eyes according to the annex VI of the Regulation EC No. 1272/2008
some details on test animals and experimental conditions were missing,
this study is considered as acceptable and satisfies the requirement for
eye irritation endpoint.
supporting substance is considered adequate for read-across purpose (see
Iuclid section 13 for justification).
No studies were available on the substance
itself regarding skin and eye irritation, therefore a read-across
approach was used. The supporting substances are considered adequate
for read-across purposes (see Iuclid section 13 for additional
Skin irritation / corrosion:
Two studies were identified on the
-cyclohexen-1-yl)-3-buten-2-one (Toxicol, 1992, rel. 2).
Both studies were performed similarly to
the OECD Guideline No. 405 and in compliance with GLP but observation
period was 7 days only, with non-reversible effects at the end of the
0.5 mL of test material was applied on the
clipped skin of the flank area of 3 female New Zealand White rabbits.
Test sites were covered with a semi-occlusive dressing for 4 h. Skin
irritation was assessed and scored according to the Draize scale at 1,
24, 48, 72 and 168 h after removal of the patches.
In the first study (Toxicol, 1984), o ne
hour after dosing, very slight to well defined erythema and slight
oedema were observed. At 24 h observation, well defined erythema and
slight to moderate oedema were observed. Very slight to slight
oedematous response was observed at 48 h after dosing. Moderate oedema
was again observed in one rabbit 72 h after dosing, other irritant
reactions remaining unchanged. The individual scores for each animal
within 3 scoring times (24, 48 and 72 h) were 2.0 / 2.0 / 2.0 for
erythema and 1.3 / 2.7 / 2.0 for oedema. At 168 h observation, very
slight to well defined erythema and oedema were observed; animals
exhibited desquamation from the surface of the treated skin.
Reversibility was not observed in any of the treated rabbits.
In the second study (Toxicol, 1985), one
hour after dosing, very slight to well defined erythema and very
slight to moderate oedema were observed. 24 h after dosing, some
changes to the intensity of oedematous reaction ware apparent; very
slight to severe oedema was observed. 48 h after dosing, very slight
to well defined erythema and slight to moderate oedema were observed.
The moderate response described had declined slightly by the seventy
two hour observation when well defined erythema and slight oedema were
observed together with desquamation from the skin surface. The
individual scores for each animal within 3 scoring times (24, 48 and
72 h) were 0.3 / 2.3 / 1.7 / 1.0 for erythema and 0.3 / 3.0 / 2.3 /
0.3 for oedema. At 168 h observation, the irritant response was
generally maintained and desquamation from the treated skin surface
was noted in three of the four animals.
Based on the scores, on the inflammation
persisting at the end of the observation period and on the presence of
desquamation, the substance requires classification for skin
A key study was identified on the
(Biosearch, 1979). In this eye irritation study performed similarly to
the OECD Guideline No. 405, undiluted test material was instilled into
the eye of 6 rabbits. The eyes were not rinsed after instillation of
the test item. Animals were observed at 24, 48 and 72 h after
instillation of test material into eyes and then on Days 5 and 7.
The calculated mean score for each animal
within 3 scoring times (24, 48 and 72 h) were 0.39 for redness, 0.33
for chemosis, 0.0 for iris lesions and 0.0 for corneal opacity. The
observed conjunctival reactions were fully reversible within 5 days.
The substance does not require
classification for eye irritation.
substance has no harmonized classification according to the Regulation
(EC) No. 1272/2008 including ATP6.
Based on the available information on the
analogue, the registered substance should be classified as Skin
irr. Category 2 (H315: Causes skin irritation) according to the Annex VI
of the Regulation (EC) No. 1272/2008 (CLP).
additional self-classification is proposed regarding eye irritation
according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
information was available regarding respiratory irritation.
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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