Fatty acids, montan-wax, stearyl esters

Endpoint summary

Description of key information

Skin, rabbit: not irritating

Read-across from analogue source substances 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), hexadecanoic acid, -isooctadecyl ester (CAS 72576-80-8) and docosyl stearate (CAS 22413-03-2)

 

Human data (single Patch test): not irritating

Read-across from analogue source substance docosyl docosanoate (CAS 17671-27-1)

Eye, rabbit: not irritating

Read-across from analogue source substances 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), hexadecanoic acid, -isooctadecyl ester (CAS 72576-80-8) and tetradecanoic acid, tetradecyl ester (CAS 3234-85-3)

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 from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Source: CAS 93803-87-3

Irritation parameter:

erythema score

Basis:

animal: #2 and #3, respectively

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Source: CAS 93803-87-3

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 93803-87-3

Further two in vivo skin irritation with the source substances docosyl stearate (CAS 22413-03-2) and hexadecanoic acid, -isooctadecyl ester (CAS 72576-80-8) are available.

CAS 22413-03-2:

No skin irritation effects were observed at any time point (24/48/72 h) in any animal.

CAS 72576-80-8:

No skin irritation effects were observed at any time point (24/48/72 h) in any animal.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The skin irritation study with the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) revealed slight erythema which had cleared completely within 48 and 72 h, respectively. Based on the results of the in vivo skin irritation studies with the source substances docosyl stearate (CAS 22413-03-2) and hexadecanoic acid, -isooctadecyl ester (CAS 72576-80-8) no skin irritating properties were observed. Moreover, the source substance docosyl docosanoate (CAS 17671-27-1) did not show any skin irritant properties in humans. Applying the read-across approach, no skin irritating properties are expected for the target substance Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5).

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 from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 93807-87-3

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 93807-87-3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 93807-87-3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Source: CAS 93807-87-3

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #2, respectively

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 93807-87-3

A further in vivo eye irritation with the source substance hexadecanoic acid, -isooctadecyl ester (CAS 72576-80-8) is available:

At the 1-hour reading time point, 3/3 rabbits had slight to moderate conjunctivae (scores 1, 1, 2) and 2/3 had slight chemosis (scores 0, 1, 1). The chemosis had cleared by the 24-hour reading time point, while 3/3 animals still had slight conjunctivae (scores 1, 1, 1). All eye irritation effects were fully reversible within 48 hours.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

Based on the results of the in vivo eye irritation studies with the source substances 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) and hexadecanoic acid, -isooctadecyl ester (CAS 72576-80-8) no eye irritating properties were observed in any of these studies. Applying the read-across approach similar results are expected for the target substance Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for read-across

Adequate experimental data on the skin and eye irritation potential of Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5) was not available. The assessment was therefore based on studies conducted with analogue substances as part of a read-across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Skin irritation/corrosion

CAS 93803-87-3

A study was performed according to OECD 404 to assess the skin irritation potential of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) (Notox, 1998). 0.5 g test substance was applied to the shaved skin of rabbits under semi-occlusive conditions for 4 hours. 3/3 animals had well-defined erythema (score 2) at the 1-hr reading time point. The erythema had reduced in severity by 24 hours after exposure in 3/3 rabbits (score 1, 1, 1), and had cleared completely within 72 hours for 3/3 rabbits. The mean score for the 24, 48 and 72 evaluation times was 0.67, 0.33 and 0.33. No edema was observed in any animal at any time point.

CAS 72576-80-8

A study was performed according to EU Method B.4 (similar to OECD 404) to assess the skin irritation potential of hexadecanoic acid isooctadecyl ester (CAS 72576-80-8) (Cosmepar, 1999). 0.5 g test substance was applied to the shaved skin of rabbits under semi-occlusive conditions for 4 hours. The skin irritation was scored 1, 24, 48 and 72 hours after exposure ended. No erythema or edema was observed in any animal at any time point.

CAS 22413-03-2

A skin irritation study was performed according to OECD 404 with docosyl stearate (CAS 22413-03-2) (Kannami Laboratory, 2016). The skin corrosive and irritating potential of docosyl stearate (CAS 22413-03-2) was examined in three female Japanese White rabbits. 0.5 g of the pulverized test substance was put on a lint patch and moistened with water for injection uniformly and applied to the dorsal skin of one animal, where fur was clipped, for 3 minutes, 1 hour or 4 hours (initial test). Since no skin corrosive reaction was observed in the initial test, application was conducted to two additional animals for 4 hours (confirmatory test). The same lint patch was also applied as a control substance in 4-hour application in both tests. The skin reactions were observed at 1, 24, 48 and 72 hours after removal of the application (by 24 hours after removal of application in 3 minute-application in the initial test) and scored according to the Draize's criteria. The individual mean score was 0 each in erythema/eschar formation and edema formation.

Human data

CAS 17671-27-1

In a single exposure patch test, 20 µL of undiluted docosyl docosanoate (CAS 17671-27-1) was applied to the upper back skin of 11 volunteers (BIO-HC, 2005). The test substance was placed in an aluminium cup (Finn Chamber Test), covering an area of approximately 50 mm². The cup was fixed to the test area with adhesive tape and left for 24 hours. A positive control cup containing 1% solution of sodium sulfate and a negative control cup containing distilled water, was fixed to the skin in parallell with the test cup. The skin irritation effects (erythema, edema, vesicles, cutaneous dryness, wrinkling, glazing) were assessed 30 minutes and 24 hours after patch removal and the subjective experience of the volunteers was recorded. 1/11 subjects were excluded as moderate erythema was noted at the negative control site. Slight to moderate erythema was observed at the test site in 3/10 subjects 30 minutes after exposure ended and in 1/10 24 hours after patch removal. The positive control was shown to be valid, as slight to moderate erythema was noted at the positive control site in 11/11 subjects. Therefore, Docosyl docosanoate (CAS 17671-27-1) was not a skin irritant under the chosen test conditions.

Eye irritation

CAS 93803-87-3

The eye irritation potential of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was evaluated in a study performed according to OECD 405 (Notox, 1998). 0.1 mL of test substance was instilled into one eye of 3 rabbits and left without washing. Remains of the test substance were noted in the treated eye of 3/3 animals on Day 1, while remains were present on the outside of the eyelids on Day 2 in 1/3 animals. At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point.

CAS 72576-80-8

In a study performed according to OECD 405, the eye irritation potential of hexadecanoic acid isooctadecyl ester (CAS 72576-80-8) was evaluated (Cosmepar, 1999). 0.1 mL of test substance was instilled into one eye of 3 rabbits. At the 1-hour reading time point, 3/3 rabbits showed slight to moderate conjunctival redness (scores 1, 1, 2) and 2/3 showed slight chemosis (scores 0, 1, 1). The chemosis had cleared by the 24-hour reading time point, while 3/3 animals still showed slight conjunctival redness (scores 1, 1, 1). All eye irritation effects were fully reversible within 48 hours.

Overall conclusion for skin and eye irritation

The available data with the source substances do not indicate a skin and eye irritation potential. Therefore, no skin or eye irritation potential is expected for the target substance Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5).

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physico-chemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5), data will be generated from data for source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Applying the read-across approach, the available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.