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Physical & Chemical properties

Additional physico-chemical information

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Endpoint:
additional physico-chemical information
Type of information:
other: Statement for CLP
Adequacy of study:
weight of evidence
Cross-referenceopen allclose all
Reason / purpose:
reference to other study
Reference
 Water solubility at 20°C: 9.74 mg/L (EC A.6, OECD 105 and OPPTS 830.7840: Flask method-slow stirring)
Water solubility:
9.74 mg/L
at the temperature of:
20 °C

pH of the saturated water phase: 6.4 - 6.9.

Reason / purpose:
reference to other study
Reference
In two skin irritation tests with PEMP, both performed according to OECD/ EC guidelines and GLP principles, no dermal effects were seen that would lead to classification for skin irritation. Furthermore an acute eye irritation test is available, performed with 3 rabbits according to OECD/EC guideline. As no adverse effects were seen in the treated eyes at 24, 48 and 72 hours, PEMP was found to be not irritating to the eye.
Endpoint conclusion:
no adverse effect observed (not irritating)
Endpoint conclusion:
no adverse effect observed (not irritating)
Endpoint conclusion:
no study available

Two skin irritation tests are available with PEMP, both performed according to OECD/ EC guidelines and GLP principles. The results of the two tests are identical. In the first, one rabbit was exposed semi-occlusively for 3 minutes, 1 hour and 4 hours. Subsequently two additional rabbits were exposed semi-occlusively for 4 hours. Exposure for 3 minutes did not induce adverse skin effects. Exposure for 1 hour gave an erythema score of 1 one hour after removal of the test substance and at the 24- and 48-hour observations. The erythema had fully resolved after 72 hours. Exposure for 4 hours resulted in very slight erythema at one of the treated skin site one hour after patch removal, at all treated skin sites at the 24- and 48-hour observations and at two treated skins at the 72-hour observation. One treated skin appeared normal at the 72-hour observation and two treated skin sites appeared normal at the 7-day observation.

In a second skin irritation test, three rabbits were exposed semi-occlusively for 4 hours. At one hour after removal of the test substance two of the three rabbits had very slight erythema (score 1). This was resolved after 24 hours. No other adverse skin effects were noted. No clinical signs were noted.

An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours.No adverse corneal or iridial effects were noted at any timepoint. No other effects were noted. Based on the results of this study, PEMP was found to be not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Two reliable studies are available, the study selected as key study represents the newest study (Klimisch 1).

Justification for selection of eye irritation endpoint:
One reliable study available.

Based on these data, PEMP was found to be not corrosive and not irritating to the skin, and PEMP was not irritating to the eye, therefore the substance is not classified according to Regulation (EC) 1272/2008.

Reason / purpose:
other: Reference to composition
Reference
Name:
Reaction mass of PEMP and TMP
Type of composition:
legal entity composition of the substance
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1

Data source

Materials and methods

Endpoint investigated:
other: corrosive to metals

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): PEMP product
- Appearance: Colourless transparant liquid

Results and discussion

Applicant's summary and conclusion

Conclusions:

The substance is slightly soluble in water and the pH of a saturated water phase is 6.4-6.9. The contituents of the substance do not contain halogens or strong acidic/basic groups. Furthermore the substance is not irritating to skin and eyes. It was therefore concluded that the substance does not have to be classified for the CLP hazard 'corrosive to metals' and testing does not need to be to be considered.