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EC number: 425-200-9
CAS number: 188570-78-7
Skin Irritation:An in vivo study according to OECD guideline 404 and in compliance with GLP is available. The results of the study do not warrant classification as a category 2 skin irritant according to CLP. Although prolonged effects for the full 14 day observation period were noted in two animals these consisted of barely perceptible erythema which are considered less severe than prolonged effects leading to classification (i.e. alopecia, hyperkeratosis, hyperplasia and scaling).Eye Irritation:An in vivo study according to OECD guideline 405 and in compliance with GLP was conducted. The study showed very slight to well-defined conjunctival irritation, however this was not sufficient to warrant classification.
Table 1 Dermal
Rabbit no. & sex
E = Erythema
O = Oedema
60 minutes after removal of the dressing
of the stratum corneum (Characterised by dryness and sloughing)
A study was performed to assess the skin
irritation potential of Montaverdi to the rabbit. The method followed
was that described in:
EEC Methods for the determination of
toxicity, Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B,
Method B.4. Acute toxicity (skin irritation) and OECD Guideline for
Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion".
Adopted: 17 July 1992. Three rabbits were each administered a single
dermal dose of 0. 5 ml of the test substance and observed for up to 14
days. A single semi-occlusive application of Montaverdi to intact rabbit
skin for four hours elicited persistent welldefined dermal irritation.
Reactions had resolved in one animal by Day 10 but slight erythema was
noted in the remaining two rabbits at study termination on Day 14. The
effects seen in 2 of the animals for the 14 day observation period were only
minimal in nature and therefore classification as a category 2 irritant is
Table 1 Ocular
Rabbit no. and sex
Region of eye
Day after instillation
- Pilot animal
An in vivo study was performed to assess the
eye irritation potential of Montaverdi to the rabbit. The method
followed was that described in:
EEC Methods for the determination of
toxicity, Annex to Directive 92/69/EEC (01 No. L383A, 29.12.92), Part B,
Method B.5. Acute toxicity (eye irritation) or OECD Guideline for
Testing of Chemicals No. 405, "Acute Eye Irritation/Corrosion". Adopted:
24 February 1987. Three rabbits were each administered a single ocular
dose of a volume of 0.1 ml of the test substance and observed for three
days after instillation. A single instillation of Montaverdi into the
eye of the rabbit elicited transient very slight to well-defined
conjunctival irritation. The scores obtained however do not lead to
classification according to the criteria set out in the DSD 67/548/EC or
the CLP Regulation (EC) 1272/2008.
Based on the scores obtained in the skin and
eye irritation study, in accordance with the classification criteria set
out in the DSD 67/548/EC and the CLP Regulation (EC) 1272/2008 the
substance does not need to be classified for skin or eye 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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