2-({3-(octadecanoyloxy)-2,2-bis[[](octadecanoyloxy)methyl]propoxy}methyl)-2-[[](octadecanoyloxy)methyl]propane-1,3-diyl dioctadecanoate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

no data on test substance purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Induction: Ten repeated applications of test substance to the same site (24 h application, 24 rest period between two applications).
Challenge: A single application on the treated and at naïve site. Reading of skin alterations.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)

EC Number:

263-423-1

EC Name:

2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)

Cas Number:

62125-22-8

IUPAC Name:

62125-22-8

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 55 (initially 56, but 1 subject did not complete the study)
- Sex: male/female
- Age: 19 - 65

Controls:

no

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: 2.54 x 2.54 cm Webril pads (cotton), held in place with Dermicel tape
- Volume applied: 0.15 mL
- Testing/scoring schedule:
The test substance was applied to backs of volunteers for 24h using patches followed by a 24-h (when applied on Monday and Wednesday) or a 48-h rest period (when applied on Friday). The procedure was repeated for a total of 10 applications. After the last application, a 14-day rest period followed. A single application to the original and at naïve site was used for challenge. Scoring was done 24 and 48 h after patch removal.
- Removal of test substance: no

EXAMINATIONS
- Grading/Scoring system:
0 = no visible reaction
1+ = mild erythema
2+ = well-defined erythema
3+ = erythema and edema
4+ = erythema and edema with vesiculation and ulceration

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: 55
- Number of subjects with equivocal reactions: none
- Number of subjects with irritating reactions: none

Applicant's summary and conclusion

Conclusions:

CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.