Reaction mass of Fatty acids, C18-unsaturated, dimers and trimers, esterified with 2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

9 April 2007 to 14 May 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Principles of method if other than guideline:

- Principle of test: An intensified version of the Repeat Insult Patch Test regimen conducted under double blind conditions on a panel of more than 100 human subjects.
- Short description of test conditions: Four 24-h applications of the test substance conducted seriatim during each of weeks 1, 2, and 3, and four 24-hour applications of the test substance conducted seriatim on a native site during the challenge week. The contacted skin was examined after each application to assess and grade the elicited effect. During the initial phase the responses that were in evidence after removal of the sample were used to determine whether applications were to be continued on the same site, switched to a new site or terminated.
- Parameters analysed / observed: skin irritation/ inflammation or sensitization

GLP compliance:

yes

Type of study:

skin painting test

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18-UNSATD., trimers, tris(16-Methylheptadecyl) esters

EC Number:

600-407-9

Cas Number:

103213-22-5

IUPAC Name:

Fatty acids, C16-18-UNSATD., trimers, tris(16-Methylheptadecyl) esters

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS:

In vivo test system

Test animals

Species:

other: Human volunteers

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: human volunteers
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation:87 female volunteers between 18-81 years old, 33 male volunteers between 18-81 year old
- Housing: Volunteers returned to the laboratory each day/week

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

150 µL

Day(s)/duration:

day 1 of weeks 1, 2, and 3

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

150 µL

Day(s)/duration:

day 1 of weeks 5 and 6

Adequacy of challenge:

not specified

No. of animals per dose:

119 volunteers in the induction phase and 114 volunteers in the challenge phase all exposed to the same dose concentration.

Details on study design:

RANGE FINDING TESTS: none

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Dose applied on Monday(s) during weeks 1, 2, and 3 and checked for irritation or other clinical signs on Tuesday, Wednesday, Thursday, and Friday of each week.
- Test groups: 1
- Control group: none
- Site: right upper arm
- Frequency of applications: 1 application per week
- Duration: 24 hours
- Concentrations: 150 µL

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Dose applied on Monday(s) during week 5 and checked for irritation or other clinical signs on Tuesday, Wednesday, Thursday, and Friday of each week.
- Exposure period: a single 24 hour exposure during week 5.
- Test groups: 1
- Control group: none
- Site: right upper arm
- Concentrations: 150 µL
- Evaluation (hr after challenge): 24 hours

Positive control substance(s):

no

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Key result

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

150 µL

No. with + reactions:

0

Total no. in group:

114

Clinical observations:

No redness or other signs of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The data do not contraindicate exposure of the skin to the product represented by the sample identified as EX-1029 for usages entailing repeated applications under conditions commensurate with or less stringent than those that prevailed during the course of the this study.