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EC number: 215-397-8
CAS number: 1325-54-8
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40215.
The irritating behaviour of the substance has been determined in adequate studies in the rat and rabbits by application of the substance into the skin and into the eye. No studies are available for respiratory irritation.
Results tabulated to follow indications according to Guidance on the
application of CLP criteria
6 rabbits (3 males and 3 females) of the Russian breed were dosed with
substance in quantities of 0.5 g to the shaved skin area in order to
find out the primary irritation index. The gauze patches were removed 24
hours after application. The reaction of the skin was appraised upon
removal during an observation period of 8 days.
Under the experimental conditions employed the test material induced
reactions of the cornea, iris and conjunctiva when instilled into the
conjunctival sac of albino rabbits' eyes.
The following mean scores (24 - 72h) were calculated:
For skin irritation/corrosion there are two studies available.
Both of them were performed following test methods similar to OECD 404
(pre-GLP and non-GLP). In the study of Thomann P (1973) the test
material used for testing was CAS 1325-54-8 / EC 215-397-8. The
substance was applied to intact and abraded skin of 6 rabbits. In the
intact skin the mean reaction score was 0.7 (24h) and in the abraded
skin the value was 2.7 (24h). The effects are reversible and after 8
days there were reduced to mean reaction score 0 (intact skin) and to
0.6 (abraded skin). The substance was classified as moderately irritant
according to the USA/FDA criteria.
The results have been evaluated according to EU/CLP criteria and
following the Guidance on Application of CLP Criteria, the conclusion is
that the substance is not skin irritant. Evaluation has been made based
on the average score per animal using the results of the original study.
Any of the animals has reached the cut-off value of 2.3. No
classification is warranted with regard to skin irritation according to
In a recent study of Alvarez i Genoher N (2002), the test material
used was CAS1195028-55-7, a substance of identical structure to CAS
1325-54-8 / EC 215-397-8 in respect of the anionic components. This
substance didn't show irritating properties when applied to skin of
rabbits. This result of this study supports the classificacion as non
There are no studies available for respiratory irritation.
For eye irritation determination there are two studies available. Study
of Hagemann CH (1993) was done according to OECD405 and is GLP compliant. Supporting
study of Thomann P (1973) was done with a similar method to OECD,
non-GLP compliant. In this study, 6 rabbits have been used and the
results obtained have been checked and compared to criteria as described
in the Guidance on application of CLP criteria. In both cases the
results showed that the substance provoques a certain effect irritation
after application of the substance to eyes of rabbits, but the effects
are fully reversible after 14 days.
Based on both results the substance is considered as non-irritant to
eyes in order to do the chemical safety assessment as well as for
Skin irritation: For classification purposes the results in the
study report of Thomann (1973), have been reviewed following the
indications on the Guidance on application of CLP criteria November
2012. The mean score per animal for erythema/eschar or for oedema
doesn't fall into the range for classification of the substance as skin
irritant according to CLP Regulation(EU Regulation 1272/2008). The
substance is not classified as skin irritant according to EU Directive
Based on the results of available studies on eye irritation CAS
1325-54-8 / EC 215-397-8 was not classified as eye irritant according to
the EU DSD classification criteria (EU Directive 67/548/EEC). According
to the EU CLP classification criteria (EU Regulation 1272/2008), CAS
1325-54-8 / EC 215-397-8 is also not classifed as eye irritant.
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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