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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Justification for non-LLNA method:
Study available before the requirement for testing using the LLNA method was implemented.
Reading:
other: unspecified
Group:
test chemical
No. with + reactions:
0
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
not sensitizing

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: repeated insult patch Test on humans
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Study available before the requirement for testing using the LLNA method was implemented.

Test material

Constituent 1
Reference substance name:
Reference substance 006
Cas Number:
56863-02-6

In vivo test system

Test animals

Species:
other: humans
Sex:
not specified

Study design: in vivo (non-LLNA)

No. of animals per dose:
102
Details on study design:
Undiluted Linoleamide DEA was evaluated for sensitization using 102 individuals in an RIPT. Ten 48-h occlusive induction patches were followed, after a 2-week nontreatment period, by a single 48-h occlusive challenge patch. No reactions
were observed to any induction or challenge patch. Linoleamide DEA was not an irritant or sensitizer

Results and discussion

In vivo (non-LLNA)

Results
Key result
Group:
test chemical
Total no. in group:
102
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not sensitizing