Registration Dossier
Registration Dossier
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EC number: 217-288-0 | CAS number: 1800-91-5
Skin sensitisation
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:
- 1 995
- 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
- 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
- Reference substance name:
- 1,6 Divinylperfluorohexane
- IUPAC Name:
- 1,6 Divinylperfluorohexane
- Test material form:
- other: Liquid
Constituent 1
Constituent 2
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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