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EC number: 939-894-0 | CAS number: -
Assessment of irritancy effects to skin and eye.
The relative mean viabilities of the test item treated tissues were as follows:
240 minutes exposure
60 minutes exposure
3 minutes exposure
Table1 Mean OD562Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Mean OD562of individual tissues
Mean OD562of duplicate tissues
Relative mean viability (%)
Negative Control Item
Positive Control Item
*= The mean viability of the negative control tissues is set at 100%
The test item was classified as non-corrosive to the skin. The following classification criteria apply:
EU DSD (67/548/EEC): Not classified for corrosivity.
EU CLP (1272/2008/EC)/ UNGHS: Not classified for corrosivity.
UN Packing Group:Non-Corrosive.
Table1 Mean OD562Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Mean OD562of triplicate tissues
Relative individual tissue viability (%)
± SD of Relative mean viability (%)
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
The test item was classified as non-irritant. The following classification criteria apply:
EU DSD & CLP Not classified for Irritation.
UN GHS Not classified for Irritation (category 3 can not be determined).
Table1 Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex
IPR = 0
Time After Treatment
E = Degree of Opacity
F = Area of Cornea Involved
Score (E x F) x 5
Score (D x 5)
A = Redness
B = Chemosis
C = Discharge
Score (A + B + C) x 2
Table2 Individual Total Scores and Group Mean Scores for Ocular Irritation
Individual Total Scores At:
Group Mean Score
Table3 Individual Body Weights and Body Weight Change
Rabbit Numberand Sex
Individual Body Weight (kg)
Body Weight Change (kg)
IPR=Initial pain reaction
- = Observation not required - considered to be zero for calculation of Group Mean Score
An assessment in vitro was not conducted. This is because OECD Guideline 438 is not a full test for eye irritation, and only provides information on whether a substance is a severe eye irritant. A negative finding would need to be followed by an in vivo study. Equivalent information on irritancy information can be obtained from the in-vitro skin corrosivity study. As this study was negative , severe eye irritation was not anticipated as the substance was not corrosive. It was considered appropriate to proceed directly to an in vivo test on these grounds.
The test item produced a maximum group mean score of 7.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
No classification is applicable.
The following data sets support the assessment of the substance as a “non-irritant”.
Evaluation under REACH Progress Report 2010, Pg 32 states as follows:
Annexes VIII-X requires an in vivo test to assess Skin irritation/corrosion. However, there are currently several in vitro methods available that can be used in a weight-of-evidence approach, to fully replace animal testing.
It is generally agreed that the EU B.46 (OECD 439) in vitro methods for Skin irritation represent a full replacement of the respective in vivo method (OECD 404) in a tiered testing strategy and in conjunction with in vitro skin corrosivity tests, if necessary. It should be noted that B.46 method does not address corrosivity; therefore, in case of positive result in a B46 test, a test addressing skin corrosion has to be performed.
It is recommended that the following testing strategy is followed when performing in vitro tests to assess skin-irritation and corrosion (see also Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance) - Skin corrosion shall be tested first; in case of positive results, no further testing is necessary; the substance shall be classified accordingly.
- If the results of the skin corrosion test is negative, then a skin irritation study according to EU method B.46 shall be performed; if the result is positive, no further testing is necessary but classification of the substance.
A negative result in the B.46 test does not need to be confirmed by additional testing.
Consequently, the default testing strategy would stop after testing skin irritation in vitro. No further in vivo testing would be required.
As the substance was negative in both in vitro screening studies, it is considered acceptable to waive the in vivo skin irritation study result on the above basis.
No corneal effects were noted during the in vivo study. Iridial inflammation was noted in one treated eye one hour after treatment. No effects were noted at 24 hours.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48-Hour observations and in one treated eye at the 72-Hour observation. Two treated eyes appeared normal at the 72-Hour observation and one treated eye appeared normal at the 7-Day observation.
No data is available for this endpoint; this is not a prescribed REACH endpoint. Historical use of white oils suggests that these materials are not respiratory irritants; the vapour pressure is not sufficiently high enough to cause effects. No effects are predicted.
Results of the studies are as follows:
The test item was classified as non-irritant and non-corrosive on the basis of two in vitro screening assessments. . The following classification criteria apply:
UN GHS Not classified for Irritation (category 3 cannot be determined).
Justification is detailed above for this overall classification.
The test item was classified as a mild irritant only on the basis of one in vivo assessment. The following classification criteria apply:
UN GHS Not classified for Irritation.
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