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EC number: 701-196-7
CAS number: -
irritation or signs of systemic toxicity were observed, except slight
erythema in 3 animals on Day 4. Variations in ear thickness during the
observation period were less than 25% from Day 1 pre-dose values. Based
on these results, the highest test substance concentration selected for
the main study was a 100% concentration.
results - main study:
No irritation of the ears was observed in
any of the animals examined.
All auricular lymph nodes of the animals of
the experimental and control groups were considered normal in size. No
macroscopic abnormalities of the surrounding area were noted for any of
No mortality occurred and no clinical signs
of systemic toxicity were observed. Body weights and body weight gain of
experimental animals remained in the same range as controls over the
LLNA skin sensitisation study was performed according to OECD/EC test
guidelines with GABEPRO® GPM-800. A reliable positive and negative
control was included. Based on the results of a pre-screen test, three
experimental groups of five female CBA/J mice were treated with test
substance concentrations of 25, 50 or 100% w/w on three consecutive
days, by open application on the ears. Five vehicle control animals were
similarly treated, but with vehicle alone (N,N-Dimethyl formamide). No
irritation of the ears was observed in any of the animals examined. All
auricular lymph nodes of the animals of the experimental and control
groups were considered normal in size. No macroscopic abnormalities of
the surrounding area were noted for any of the animals. Mean DPM/animal
values for the experimental groups treated with test substance
concentrations 25, 50 and 100% were 1112, 2154 and 1545 DPM,
respectively. The mean DPM/animal value for the vehicle control group
was 426 DPM. The
SI values calculated for the substance concentrations 25, 50 and 100%
were 2.6, 5.1 and 3.6, respectively. Based on these data, the substance
is considered to be a skin sensitiser in accordance with the CLP
Regulation (sub-category 1B), as it was shown that GABEPRO® GPM-800
could elicit a SI ≥3. An EC3 value of 29% was calculated.
a LLNA study it was shown that GABEPRO® GPM-800 could
elicit a SI ≥3. Based on this result, GABEPRO®
GPM-800 needs to be classified as a skin sensitiser, according to Regulation
(EC) No 1272/2008 on Classification, Labelling and Packaging of Substances
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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