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EC number: 609-530-2
CAS number: 38172-91-7
Skin irritation (OECD 404; BASF AG, 1987): not irritatingEye irritation (OECD 405, BASF AG, 1987): irreversible effects on the eye
The skin irritation potential of the test
substance was evaluated based on a test according to OECD guideline 404.
The fur of three animals (2 males, 1 female) was clipped and the
undiluted test substance was applicated using a test patch (2.5 x 2.5
cm) soaked with 0.5 ml of the undiluted test substance. The patch was
applicated onto the upper third of the back or flank. After an exposure
period of 4 hours the skin was washed with Lutrol and Lutrol/water (1:1)
followed by a 72 hours observation period with readings after 30 min and
60 min after the removal of the test patches and 24 h, 48 h and 72 h
after the beginning of application. Untreated skin sites of the same
animal were used as negative control. The severity of substance induced
edema and erythema was quantified for each time point using the
following values: 0 = none, 1 = very slight, 2 = well-defined, 3 =
moderate to severe, 4 = severe to very severe. The edema and erythema
scores were calculated as mean of the single values of the time points
24 h, 48 h and 72 h and all three animals. The test substance did not
cause any edema or erythema except in one male which developed a very
slight erythema extending beyond the area of exposure after 4 hours
which was fully reversible within 20 hours. The mean erythema and edema
scores were 0.0 in each of 3/3 animals after 24/48 and 72 hours and the
test substance was classified as not irritating to the skin.
The eye irritation potential of the test
substance was evaluated in a test according to OECD guideline 405. A
single application of 0.1 ml of the unchanged test substance was given
into the conjunctival sac of the right eyelid of three rabbits (2 males,
1 female). The substance was not washed out. Eye effects were documented
1 h, 24 h, 48 h, 72 h, 8 days, 15 days and 21 days after the
application. The untreated eyes of the animals were used as negative
control. The severity of substance induced eye effects was quantified
for each time point using the following values: opacity and swelling (0
= none, 1 = very slight, 2 = well defined, 3 = moderate to severe, 4 =
severe to very severe), redness (0 = normal, 1 = slight, 2 =
well-defined, 3 = severe) and iris (0 = normal, 1 = circum-corneal
injection, 2 = iritis). The irritation scores were calculated as mean of
the single values of the time points 24 h, 48 h and 72 h and all three
animals: Cornea score = 0.2 (mean score 0 in 2/3 animals; 0.7 in 1/3
animals), conjunctivae score = 1.6 (mean score 2 in 1/3 animals; 1 in
1/3 animals; 1.7 in 1/3 animals), iris score = 0.0 (mean score 0 in each
of 3/3 animals) and chemosis score = 0.4 (mean score 0 in 2/3 animals;
1.3 in 1/3 animals). Effects on cornea opacity was fully reversible
within 72 hours in 1/3 animal, not reversible within 21 days in 1/3
animals (grade 2 at the end of the observation period) and one animal
did not develop cornea effects. Redness was fully reversible within 72
hours in 1/3 animals, within 8 days in 1/3 animals and not reversible
within 21 days in 1/3 animals. Swelling was fully reversible within 24
hours in 2/3 animals and not reversible within 21 days in 1/3 animals.
One male animal showed contracted pupils starting 48 hours after
application until day 21. Eight days after application of the test
substance this animal also developed small retractions in the eyelid,
loss of corneal tissue and suppuration. These effects persisted
unchanged until day 21. Furthermore this animal showed marginal
vascularization of the cornea on day 21 while the second male did not
show any of these effects at any time point. The female developed loss
of corneal tissue and contracted pupils only 48 hours after application
of the test substance. These effects were fully reversible within 24
hours. Based on the irreversible effects in one animal, the test
substance hold the risk of serious eye damage.
Effects on eye irritation: corrosive
Based on the skin irritation study,
classification of skin irritation is not warranted according to EU
directive 67/548/EEC and EU classification, Labelling and Packaging of
Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Based on the eye irritation study, the test
substance poses the risk of serious damage to the eye (R41) according to
EU directive 67/548/EEC and has to be classified as Eye irritant Cat. 1
according to EU classification, Labelling and Packaging of Substances
and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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