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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation / corrosion in vivo (OECD 404): not irritating

Study performed with the analogue source substance fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7)

Eye irritation in vivo (OECD 405): not irritating

Study performed with the analogue source substance isooctadecyl palmitate (CAS 72576-80-8)

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)
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
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Source: EC 701-233-7, NOF, 2008, rabbit
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Source: EC 701-233-7, NOF, 2008, rabbit
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Source: EC 701-233-7, NOF, 2008, rabbit
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Source: EC 701-233-7, NOF, 2008, rabbit
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Source: EC 701-233-7, NOF, 2008, rabbit
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Source: EC 701-233-7, NOF, 2008, rabbit
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
A reliable study conducted accordance with OECD 404 and GLP, found the test material to be non-irritating to the skin of rabbits. No skin reactions were observed at any observation time point. Erythema and edema scores were all 0.
Executive summary:

The potential of the target substance docosyl docosanoate (CAS 17671-27-1) to induce skin irritation or corrosion is estimated based on an adequate and reliable in vivo study with an analogue source substance. In this study the test substance did not induce erythema or edema formation (all scores 0). Therefore, the lack of any skin irritation or corrosion potential is taken forward to the hazard assessment and the determination of the classification of the target substance. As explained in the Analogue Justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin irritation potential.

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)
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
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 72576-80-0, Stearinerie, 1999
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 72576-80-0, Stearinerie, 1999
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Source: CAS 72576-80-0, Stearinerie, 1999
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Source: CAS 72576-80-0, Stearinerie, 1999
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Source: CAS 72576-80-0, Stearinerie, 1999
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 72576-80-0, Stearinerie, 1999
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
A reliable study conducted in accordance with OECD guideline 405 and GLP found the test material to be non-irritating to the eyes of rabbits. Mild conjunctival reactions and chemosis (max. score 1) were recorded in some animals but all eye irritation effects were fully reversible within 48 h.
Executive summary:

The potential of the target substance docosyl docosanoate (CAS 17671-27-1) to induce eye irritation or serious eye damage is estimated based on an adequate and reliable in vivo study with an analogue source substance. In this study the test substance induced only slight conjunctival reactions and chemosis (max. score 1). All eye irritation effects were fully reversible within 48 h. Therefore, the lack of an eye irritation or corrosion potential is taken forward to the hazard assessment and the determination of the classification of the target substance. As explained in the Analogue Justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the eye irritation potential.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on skin or eye irritation are available for docosyl docosanoate (CAS 17671-27-1). Adequate and reliable studies performed with analogue source substances are, therefore, used to assess the endpoints skin irritation / corrosion and eye irritation.

Skin irritation / corrosion

The skin irritation potential of fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7) was investigated according to OECD guideline 404 and GLP conditions (NOF, 2008, rabbit). The unchanged test substance was moistened with water and applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of exposure was 4 h. The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the dressing. The test substance did not elicit any skin reactions in any animal at any observation times (all erythema and oedema scores were 0). No clinical signs were observed in any of the animals. Thus, fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters did not induce significant or irreversible damage to the skin and it is concluded that the test substance has no skin irritation potential.

Eye irritation

In a study performed according to OECD guideline 405 and GLP principles (Stearinerie, 1999), the eye irritation potential of hexadecanoic acid isooctadecyl ester (CAS 72576-80-8) was evaluated. 0.1 mL of the neat test substance was instilled into one eye of three male New Zealand White rabbits. At the 1 h reading time point, 3/3 rabbits showed 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 h reading time point, while 3/3 animals still had slight conjunctivae (scores 1, 1, 1). All eye irritation effects were fully reversible within 48 h. Based on these findings, the test substance hexadecanoic acid isooctadecyl ester is not considered to exhibit an eye irritation potential.

Justification for classification or non-classification

The available data on skin and eye irritation / corrosion for adequate analogue source substances do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are conclusive but not sufficient for classification. Based on an analogue read-across approach, the target substance docosyl docosanoate (CAS 17671-27-1) is, therefore, also not classified for skin or eye irritation.