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Description of key information

No signs of skin irritation were observed in any of the guideline studies (RL1) with various types of Montan waxes (Montan waxes, types CaV 102, NaV 101 and E).

In reliable studies Montan waxes, types CaV 102 and E produced slight eye irritation (RL1), but not of a magnitude requiring classification as eye irritants.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable as no effects observed at any time
Remarks on result:
other: Montan wax, type E
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applaicable as no effects observed at any time
Remarks on result:
other: Montan wax, type E
Interpretation of results:
GHS criteria not met
Conclusions:
In reliable studies members of the category of Montan waxes were not irritating to the skin of rabbits.
Executive summary:

The studies used as source investigated the skin irritating potential of members from the category of Montan waxes.

The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Reason / purpose for cross-reference:
assessment report
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable as no effects observed at any time
Remarks on result:
other: Montan wax, Type E
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable as no effects observed at any time
Remarks on result:
other: Montan wax, type E
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48 h;
Remarks:
individual mean scores 0, 0.33, 0.33; maximum score observed: 1
Remarks on result:
other: Montan wax, type E
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours;
Remarks:
grade 1 chemosis was observed at 1 hour post exposure
Remarks on result:
other: Montan wax, type E
Interpretation of results:
GHS criteria not met
Conclusions:
In reliable studies members of the category of Montan waxes (undiluted test materials) were not irritating to the eyes of rabbits.
Executive summary:

The studies used as source investigated the eye irritating potential of members from the category of Montan waxes.

The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In guideline studies (RL1) with Montan waxes, types CaV 102, NaV 101 and E (RL1) there were no signs of skin irritation. Montan wax, type NaV 101 was also tested in a less reliable study (RL3) and was not irritating to the skin of rabbits.

The only report of minor irritating properties comes from a Barail test with Montan waxes, type KPS (RL3). A slight reddening was observed after intracutaneous injection of a 1% solution in sesame oil. Lower dilutions were not irritating. However, this test protocol does not meet important criteria of today standard methods, and the dermal application of 1% solution onto shaved skin revealed no irritant properties in the same study.

Based on these results there is no concern of skin irritation by the Montan waxes included in this category.

 

Eye irritation

In guideline studies (RL1) with Montan waxes, types CaV 102 and E, there were signs of slight eye irritation (transient redness, discharge). A RL1-study with type NaV101 (pure) provoked a somewhat stronger irritating response (iris and conjunctivae reddening, chemosis), possibly an effect of a pH shift of this sodium salt of a carbonic acid. However, the effect size was clearly below the criteria for classification as an eye irritant.

In a less reliable study (RL3) tested Montan waxes, type NaV101, with the substance applied in 5 or 15% suspensions in sesame oil no eye reactions were observed. Further, a less reliable study (RL3) with Montan waxes, type KPS revealed only slight signs of irritation, confirming the results of the key studies.

 

Respiratory irritation

No information is available, but inhalation is not expected to be an exposure route of concern (see above).

Justification for classification or non-classification

No evidence for skin irritation is emerging from the guideline studies performed with Montan waxes, types CaV 102, NaV 101 and E. Therefore, the Montan waxes category members have not to be classified for skin irritation according to Regulation (EC) No 1272/2008. The Montan waxes in pure form are only very slightly irritating to the eyes in guideline studies, and the findings are supported by the less reliable (RL3) studies, leading to scores well below classification thresholds. Therefore, the Montan waxes category members have not to be classified for eye irritation according to Regulation (EC) No 1272/2008.

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