Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
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:
Data is from peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Glyceryl Oleate
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1986
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY; Volume 5, Number 5, 1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of 2,3-dihydroxypropyl octadec-9-enoate in human by repeated insult patch test.
GLP compliance:
not specified
Type of study:
other: repeated insult patch test (RIPT)
Justification for non-LLNA method:
Not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 2,3-Dihydroxypropyl 9-cis-octadecenoate; Glyceryl monooleate
- Molecular formula : C21H40O4
- Molecular weight: 356.54 g/mole
- Substance type: Organic
- Physical State: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,3-Dihydroxypropyl 9-cis-octadecenoate; Glyceryl monooleate
- Molecular formula :C21H40O4
- Molecular weight:356.54 g/mole
- Substance type:Organic
- Physical State: Solid

In vivo test system

Test animals

Species:
other: Human
Strain:
other:
Remarks:
Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
5%
Day(s)/duration:
24 hour
Challenge
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
5%
Day(s)/duration:
24 hour
No. of animals per dose:
15 human
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 hour
- Test groups: 15
- Control group: No data available.
- Site: Topical application
- Frequency of applications: On Tuesdays, Thursdays, and Saturdays
- Duration: 10 days
- Concentrations: 5%

B. CHALLENGE EXPOSURE
- No. of exposures: 10
- Day(s) of challenge: 12-16 days
- Exposure period: 24 hour
- Test groups: 15
- Control group: No data available.
- Site: Topical application to the adjacent site of induction exposed site.
- Concentrations: 5%
- Evaluation (hr after challenge): Evaluated immediately after patch removal and 24 h later.


Challenge controls:
No data available.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Challenge
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No skin sensitization reaction was observed.
Remarks on result:
no indication of skin sensitisation
Reading:
other: Challenge
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No skin sensitization reaction was observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No indication of skin sensitization was observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
2,3-dihydroxypropyl octadec-9-enoate (111-03-5) was observed for its skin sensitizing poptential in human by repeated insult patch test. 2,3-dihydroxypropyl octadec-9-enoate was considered to be non sensitizing in human by RIPT .
Executive summary:

Skin sensitization for2,3-dihydroxypropyl octadec-9-enoate (111-03-5) was observed in human byrepeated insult patch test. An RIPT with a sunscreen formulation containing 5% test material was conducted using an occlusive patch technique. Ten 24-h induction patches on Tuesdays, Thursdays, and Saturdays were applied. The sites were evaluated after removal of each patch. After a rest period of 12-l 6-day. A 24-h challenge patch at an adjacent site was applied. These challenge sites were then evaluated immediately after patch removal and 24 h later. None of the 15 subjects was observed with skin sensitization effect during the induction phase or when challenged. Therefore 2,3-dihydroxypropyl octadec-9-enoate (111-03-5) was considered to be non sensitizing in human.