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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human repeated insult patch test
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
1,5,10-trimethylcyclododeca-1,5,9-triene, epoxidised
EC Number:
945-746-6
Molecular formula:
Not Applicable
IUPAC Name:
1,5,10-trimethylcyclododeca-1,5,9-triene, epoxidised
Test material form:
not specified

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 50 subjects;
- Sex: 29 males; 21 females
- Age: Males: 22-48 years (Caucasian); 28 year (negro); 23-34 years (oriental) /females: 19-52 years (Caucasian); 30 year (oriental)
Clinical history:
None
Controls:
White Petrolatum
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Occlusive
- Description of patch: oval-shabed adhesive patches (1" x 1-1/4") with curcular gauze centers
- Vehicle / solvent: White petrolatum
- Concentrations: 2% in White Petrolatum
- Volume applied: Approximately 0.3 mL
- Testing schedule:
Phase I (Induction phase): Total of 9 induction applications
Phase III (challenge phase): 2 weeks after the last induction, on a new skin site, for 24-hr

EXAMINATIONS
Grading/Scoring system: Scoring Criteria for Skin Irritation Reactions

- Erythema and Eschar Formation:
No reaction: 0
Very slight erythema (barely perceptible): 1
Mild, well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

- Oedema Formation:
No reaction: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edge of area well-defined by definite raising): 2
Moderate oedema (area raised approximately 1 mm): 3
Severe oedema (area raised more than 1 mm and extending beyond area of exposure): 4

- Statistical analysis: None

Results and discussion

Results of examinations:
SYMPTOMS
None

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
Under the condition of the study, the test material is not a skin sensitizer at 2% in White Petrolatum.
Executive summary:

A panel of 50 male and female human volunteers participated in a repeat insult patch test in which a 2% in White Petrolatum of the test material was applied under occlusive patches. During the induction phase nine patches were applied. Two weeks after the last induction application, a challenge patch was applied and the sites scored 24 h (after removal of patch).

 

Under the conditions employed in this study, there was no evidence of sensitisation to the test material.