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EC number: - | CAS number: -
Skin irritation/corrosion: not irritating (OECD 404, GLP, analogue approach)Eye irritation: not irritating (OECD 405, GLP, analogue approach)
Intact skin reactions
Abraded skin reactions
The skin irritation potential was tested in New Zealand White rabbits. The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Under the conditions of the present experiment the test compound was found to cause a slight irritation when applied to intact and abraded rabbit skin. One animal died after 6 days.
The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results according to the CLP Regulation (1272/2008), because the raw tables are included into the study report. Only the intact skin reactions were considered.
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).
The test was performed on 3 male and 3 female New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into
the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed.
The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.
Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa.
One animal died at Day 7. No symptoms had been observed previously.
The criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline. The scoring system used for the corea opacity and degree of density, for the iris and conjunctivae redness and chemosis is the same of that reported into the OECD, but the timing for the removal of the substance are very different (30 seconds in the current study and 1 hours in the OECD). Nevertheless, because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (1272/2008).
The mean values from gradings at 24, 48 and 72 hours for both rinsed and unrinsed eyes were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.
Therefore the substance does not meet the criteria to be classified as eye irritating.
There are no data available for the skin and eye irritation potential of CAS 12004488-68-5. In order to fulfil the standard information requirements, a read-across from structurally related substance was conducted.
An acute dermal irritation study performed similar to OECD Guideline 404 to evaluate the skin irritation potential of CAS# 16470-24-9 is available. Six New Zealand rabbits were treated with 0.5 g of the test substance for 24 h under occlusive conditions. The animals were observed for 7 days. Under the conditions of the present experiment the test compound was found to cause a slight irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 1.5. One animal died after 6 days but no symptoms had been observed previously. Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin). Therefore, the test substance is not considered irritating to the skin.
An acute eye irritation study was performed according to OECD Guideline 405 under GLP conditions. 0.1 g of the unchanged test substance was instilled to the left eye of three male and three female New Zealand White rabbits. The untreated right eye served as control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed. The eye irritation was appraised with a slit-lamp on Day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa. The primary irritation index was found to be: unrinsed eyes = 0.4; rinsed eyes = 0.1. One animal died at Day 7 but no symptoms had been observed previously. All effects were fully reversible within 48 hours. Therefore, the test substance is not considered eye irritating in this study.
Based on read-across from the structurally similar substances, the available data for skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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