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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 1995 To December 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP OECD guideline study. No information on laboratory regular verification of test system with positive controls. Lack of details with negative control procedure.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
No data on positive control
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
No data on positive controls in the study report. According to the Test Guideline in use at the time of the test, a reliability check by the test laboratory was required every 6 months, but not necessarily concurrent with each study.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was carried out according to one of the validated OECD test guideline available at the time, i.e., prior to the development and validation of the LLNA test method.

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
EC Number:
217-288-0
EC Name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
Cas Number:
1800-91-5
Molecular formula:
C10H6F12
IUPAC Name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
Constituent 2
Reference substance name:
1,6 Divinylperfluorohexane
IUPAC Name:
1,6 Divinylperfluorohexane
Test material form:
other: Liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 1-3 months
- Weight at study initiation: 300-500 g
- Housing: 2 or 3 animals/cage in air-conditioned room ; grill cages 40.5x38.5x18 cm
- Diet (e.g. ad libitum): GLP certificate 8 GP 22 (Mucedola S.r.l. Settimo Milanese)
- Water: ad libitum
- Acclimation period: at least 5 days before the start of the test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-
- Humidity (%): 55 +/- 10
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12h/12 h (light: 7am-7pm)

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Test item applied undiluted
Day(s)/duration:
3 exposures of 6 hours, once a week
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
test item applied undiluted at challenge
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 animals/treatment group
10 animals/control group
Details on study design:
Induction phase: 3 exposures of the undiluted test item, once a week, 6 h each patch
Challenge application: 1 exposure to undiluted test material, 6h patch, 15 days after the last inductive phase
Challenge controls:
no data
Positive control substance(s):
not specified
Remarks:
at the time of test, the test guideline required reliability check with positive control substance once every 6 months.

Results and discussion

Positive control results:
No data in the study report. According to the test guideline in use the laboratory was required to check the reliability of the technique with a positive control test every 6 months.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: The results of the reliability check performed by the laboratory every 6 month was not reported in the study report

Any other information on results incl. tables

No sign of irritation was observed during the induction phase.

The body weight gain was normal throughout the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this test, the test substance did not appear to possess sensitizing properties.
Executive summary:

The sensitization of the test article, 1,6 Divinylperfluorohexane, was assessed in guinea-pig using OECD Guidelines 406 (Buehler test). The body weight gain in the animals throughout the test was normal. Twenty-four hours after 6h patch application of each inductive phase, no signs of skin irritation were observed in the animals treated with the test article. No animal treated with the test article concentration applied (undiluted) showed positive reaction at the challenge. No skin reactivity was observed in the negative control group. On the basis of this result, under the experimental conditions applied, 1,6 Divinylperfluorohexane did not appear to possess sensitizing properties.

The test method is acceptable for CLP classification purposes. No classification is required according to CLP criteria.

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