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EC number: 274-570-6
CAS number: 70321-86-7
- Skin: The substance did not cause skin
irritation in the rabbit skin. Neither erythema nor oedema was evident
within 7 days following a 24 hour exposure duration.
- Eye: Conjunctival reactions were seen in
2 of 6 animals. The effects on the conjunctivae were fully reversible
in all affected animals within 7 days after instillation. Very slight
corneal opacity which was seen in only 2 of 6 animals was fully
reversible by day 4 following instillation.
In accordance with conventional practice, only results of the non
scarified skin sections are adopted in the final assessment for skin
As a consequence of the poor documentation of the results (only
average scores but not individual animal scores were provided), the
parameters conjunctivae redness and swelling could not be assessed fully
for unwashed eyes. Nevertheless, from the documented results, it is
evident that conjunctival effects were totally absent in one animal over
the observation period (score = 0), fully reversible in the
second animal within 48 hours after start of treatment and fully
reversible in the third animal by day 7.
In a primary
dermal irritation study, performed using a method identical to that
described in the Federal Register, 38, No.187 §1500.41. 0.5 g of the
test substance (no data on analytical purity) was applied under
occlusive cover to the intact and abraded skin (2.5 x 2.5 cm) of 6
rabbits of Himalayan breed. Treatment was terminated (skins were not
washed) 24 hours following application and the animals were observed for
up to 7 day in which time irritation was scored according to the Draize
method 24, 48 and 72 hours after begin of treatment. Average scores per
animal - computed from the individual scores on intact skin at the 24,
48 and 72 hour post start of treatment – were 0 for erythema (maximal
attainable score = 4), and 0 for edema (maximal attainable score = 4).
No signs of skin irritation were evident by the end of the observation
period (day 7).
Because of its
lack of scientific justification and gross deviation from today's
acceptable standardized procedures for the appraisal of skin irritation,
results from the abraded skins are not included in the final judgment
for skin irritation of the test substance.
The eye irritation potential of the test
substance was determined in a procedure identical to the procedure
described in the Federal Register 38, No.187
§1500.42. 0.1 g of the substance was applied to the
conjunctival sac of the left eye of each of 6 rabbits (Himalayan breed).
After application the eye lids were closed for ca. one second. The right
eye remained untreated and served as control. Thirty seconds after
instillation, treated eyes of 3 of 6 animals were rinsed with water (10
mL). Irritation was appraised after 24, 48, 72, 96 and 168 hours.
Appraisal of eye irritation was according to the method of draize.
Average draize scores after 24, 48 and 72 hours were calculated per
animal for corneal opacity, iritis, conjunctivae redness and chemosis.
No indication of eye irritation was seen in
those animals whose eyes were washed. All scored parameters (redness,
corneal opacity, chemosis, iritis) in the 3 animals whose eyes were
washed produced a draize score of 0 (over the entire observation period).
As a consequence of the poor
documentation of the results - only average scores and no individual
animal scores were provided, - the parameters conjunctivae redness and
swelling could not be fully assessed for unwashed eyes (In this study
conjunctivae was appraised as a combination of effects resulting from
redness, swelling and discharge). Nevertheless, from the documented
results, it is evident that conjunctival effects were totally absent in
one animal (score = 0) over the observation period and fully reversible
within 48 hours and day 7 in the second and third animal, respectively.
Taken together, this indicates a low irritation potential of the test
Classification, Labelling, and Packaging
Regulation (EC) No. 1272/2008
The available experimental test data are
reliable and suitable for the purpose of classification. Based on the
criteria laid down in Regulation (EC) No.1272/2008, as amended for
time in Directive EC 944/2013, classification for
skin and eye irritation is not warranted.
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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