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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Remarks:
other: Human volunteer study
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Report of apparently well conducted human volunteer trial with detail of volunteer panel and reactions to treatment. Test material said to be directly comparable to pinene oliogomers (and reported characteristics support this). Study findings are supported by a separate (incompletely reported) human repeat-insult patch test of the same test substance in which 50 male volunteers apparently showed no skin irritation or sensitisation reactions.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Closed patch applied to skin of human volunteers for 24h: after recording of irritation, challenge by repeat patching 10-14 days later
GLP compliance:
not specified
Type of study:
other: Investigation of primary irritation and contact sensitisation using the Closed Patch procedure

Test material

Constituent 1
Reference substance name:
Foxlene Type M
IUPAC Name:
Foxlene Type M
Constituent 2
Chemical structure
Reference substance name:
Oligomerisation products of beta-pinene
EC Number:
701-246-8
Molecular formula:
Variable (dimer = C20-H34)
IUPAC Name:
Oligomerisation products of beta-pinene
Details on test material:
- sample number 1158
- substance produced by reaction directly equivalent to that now used for manufacture of pinene oligomers and identified as terpene polymer. Reported MW corresponds to the number-average MW of pinene oligomers.

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
42 adult males, 18-57 years old, 11 with declared allergies. 15 adult females, 18-57 years old, 4 with declared allergies.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: primary irritation evaluation after 1st patch removal
Group:
test chemical
Dose level:
Undiluted test substance
No. with + reactions:
0
Total no. in group:
57
Clinical observations:
No skin reactions observed
Remarks on result:
other: Reading: other: primary irritation evaluation after 1st patch removal. Group: test group. Dose level: Undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 57.0. Clinical observations: No skin reactions observed.
Reading:
other: sensitisation evaluation after 2nd patch removal
Group:
test chemical
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
No skin reactions observed
Remarks on result:
other: Reading: other: sensitisation evaluation after 2nd patch removal. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 53.0. Clinical observations: No skin reactions observed.

Any other information on results incl. tables

No skin reactions indicative of primary irritation or contact sensitisation were observed in human volunteers.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, no evidence of human contact sensitisation was obtained.