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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
sensitisation data (humans)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Type of sensitisation studied:
skin
Study type:
study with volunteers
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the skin sensitisation of glyceryl linoleate.
- Short description of test conditions: Human patch test.
- Parameters analysed / observed: Skin sensitisation/irritation.
GLP compliance:
not specified
Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 91
- Sex: Males and females
- Age: 18 - 65
Clinical history:
Not applicable - volunteer study.
Controls:
Liquid paraffin patches served as the negative control
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Draize repeat insult patch test

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn chambers with Scanpor tape applied to the upper back
- Vehicle / solvent: Liquid paraffin
- Concentrations: 50%
- Volume applied: 0.02 ml
- Testing/scoring schedule: Test days 1, 2, 4, 7, 9, 11, 14, 16 and 18
- Removal of test substance: 23 hours and 47 hours

EXAMINATIONS
- Grading/Scoring system: 0 (no visible reaction) to 5 (bullous reaction)
- Statistical analysis: Not specified.
Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 74
- Number of subjects with irritating reactions: 0

Conclusions:
Glyceryl linoleate did not induce irritation or sensitisation in the modified Draize repeat-insult patch test.
Executive summary:

Glyceryl linoleate was assessed for sensitisation potential in the modified Draize repeat-insult patch test. Human volunteers (n=74) were treated with glyceryl linoleate patch tests. The patch tests used were Finn Chambers on Scanpor tape with 50% glyceryl linoleate in liquid paraffin. An initial induction patch was applied to the back for 23 hours on test day 1, then patch tests were applied for 47 hours on test days 2, 4, 7, 9, 11, 14, 16 and 18. Reactions were scored after patch removal on a scale of 0 (no visible reaction) to 5 (bullous reaction). On test day 35, challenge patches were applied to the back for 47 hours and scored 1 and 49 hours after patch removal. Glyceryl linoleate did not induce skin irritation or sensitisation in the human repeat insult patch test.

Data source

Reference
Reference Type:
publication
Title:
Final Report of the Amended Safety Assessment of... (see remarks)
Author:
Cosmetic Ingredient Review
Year:
2004
Bibliographic source:
International Journal of Toxicology 23(Suppl. 2):55-94

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the skin sensitisation of glyceryl linoleate.
- Short description of test conditions: Human patch test.
- Parameters analysed / observed: Skin sensitisation/irritation.
GLP compliance:
not specified

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 91
- Sex: Males and females
- Age: 18 - 65
Clinical history:
Not applicable - volunteer study.
Controls:
Liquid paraffin patches served as the negative control
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Draize repeat insult patch test

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn chambers with Scanpor tape applied to the upper back
- Vehicle / solvent: Liquid paraffin
- Concentrations: 50%
- Volume applied: 0.02 ml
- Testing/scoring schedule: Test days 1, 2, 4, 7, 9, 11, 14, 16 and 18
- Removal of test substance: 23 hours and 47 hours

EXAMINATIONS
- Grading/Scoring system: 0 (no visible reaction) to 5 (bullous reaction)
- Statistical analysis: Not specified.

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 74
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
Glyceryl linoleate did not induce irritation or sensitisation in the modified Draize repeat-insult patch test.
Executive summary:

Glyceryl linoleate was assessed for sensitisation potential in the modified Draize repeat-insult patch test. Human volunteers (n=74) were treated with glyceryl linoleate patch tests. The patch tests used were Finn Chambers on Scanpor tape with 50% glyceryl linoleate in liquid paraffin. An initial induction patch was applied to the back for 23 hours on test day 1, then patch tests were applied for 47 hours on test days 2, 4, 7, 9, 11, 14, 16 and 18. Reactions were scored after patch removal on a scale of 0 (no visible reaction) to 5 (bullous reaction). On test day 35, challenge patches were applied to the back for 47 hours and scored 1 and 49 hours after patch removal. Glyceryl linoleate did not induce skin irritation or sensitisation in the human repeat insult patch test.