Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
To address multiple toxicological endpoints as part of the REACH registration of the REACH registration of Aldehyde C9 (Nonanal) (Target Substance) it is proposed to read-across to Aldehyde C10 (Decyclic) (Source Substance).

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

The Target Substance and Source Substance have been characterised in Table 1 of the attached document using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling in this table, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific.

The following tables and paragraphs contain the Target Substance and information on the Source Substance used to support registration. These substances have been assessed as suitable for completing the Lead Substance data gap analysis based on the criteria established and implemented in the OECD [Q]SAR Toolbox by ECHA.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Draize AH (1959). Appraisal of the safety of chemicals in food, drugs and cosmetics, The Association of Food and Drug Officials of the United States, p52
GLP compliance:
no
Remarks:
study predates GLP
Type of study:
other: Human repeat insult patch test (HRIPT)
Justification for non-LLNA method:
LLNA not available at time of testing
Concentration / amount:
5 %
Reading:
1st reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
0
Total no. in group:
37
Clinical observations:
Little or no primary irritation was caused by the test sample.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 37.0. Clinical observations: Little or no primary irritation was caused by the test sample..
Reading:
2nd reading
Hours after challenge:
96
Group:
test group
No. with + reactions:
0
Total no. in group:
37
Clinical observations:
Little or no primary irritation was caused by the test sample.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 37.0. Clinical observations: Little or no primary irritation was caused by the test sample..

None of the 37 subjects was sensitised by the sample.

ANALOGUE APPROACH JUSTIFICATION:

- See Section 13 "Justification for read-across" document for full details.

- In summary,to address toxicological endpoints as part of the REACH registration ofNonanal(Target Substance) it is proposed to read-across toDecanal(Source Substance).

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD (Q)SAR Toolbox. From the profile, it can be seen that the two substances share structural similarities and also "mechanistic action" similarities which are both general and endpoint specific.

Therefore read-across is justified.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for sensitisation over a 48 hour period. None of the subjects tested were sensitized during the test. Therefore the test substance is not classed as sensitising.
A valid study is available for the analogue substance, Decanal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. The read-across is considered to be suitable based on the structural and “mechanistic action” similarities between the target substance (Nonanal) and source substance (Decanal) and their similar physico-chemical properties.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the absence of available data for nonanal, data for homologue decanal are presented. The test material was found to be non-sensitising in a Human Repeat Insult Patch Test (HRIPT), and this has been used as a key study. Supporting studies from 3 week fixed dose, Draize test, and guinea pig maximisation test (GPMT) support this finding. However, one positive result has been discounted which was an intradermal FCAT study.


Migrated from Short description of key information:
A valid study is available for the analogue substance, Decanal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. The read-across is considered to be suitable based on the structural and “mechanistic action” similarities between the target substance (Nonanal) and source substance (Decanal) and their similar physico-chemical properties. Further studies on Decanal were used to support the key study.

Justification for selection of skin sensitisation endpoint:
A valid study is available for the analogue substance, Decanal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. The read-across is considered to be suitable based on the structural and “mechanistic action” similarities between the target substance (Nonanal) and source substance (Decanal) and their similar physico-chemical properties. Further studies on Decanal were used to support the key study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A valid study is available for the analogue substance, Decanal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. The read-across is considered to be suitable based on the structural and “mechanistic action” similarities between the target substance (Nonanal) and source substance (Decanal) and their similar physico-chemical properties. Further studies on Decanal were used to support the key study.

The test material was found to be non-sensitising in a Human Repeat Insult Patch Test (HRIPT), and this has been used as a key study. Supporting studies from 3 week fixed dose, Draize test, and guinea pig maximisation test (GPMT) support this finding.