Registration Dossier
Registration Dossier
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EC number: 603-501-8 | CAS number: 13171-18-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August 2017 thru 22 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Sponsor (located outside the EU) performed test to satisfy US EPA new substance requirements based on guidance given by the testing laboratory. At the time the test was initiated, the sponsor had no plans to prepare/submit a REACH registration.
Test material
- Reference substance name:
- 1,1,1,3,3,3-hexafluoro-2-methoxypropane
- Cas Number:
- 13171-18-1
- Molecular formula:
- C4-H4-F6-O
- IUPAC Name:
- 1,1,1,3,3,3-hexafluoro-2-methoxypropane
- Test material form:
- liquid: volatile
Constituent 1
- Specific details on test material used for the study:
- CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- ANIMALS:
Sex: Male
Age: Young adult
Weight: 319 - 461 grams at experimental start
Source: Received from Hilltop Lab Animals, Inc. on 3 August 2017 and 24 August 2017.
HUSBANDRY:
Stainless steel cages with enrichment (e.g. toy), litter paper changed at least three times per week.
Temp: 19 - 23 deg C and 49 - 75% relative humidity
Room Air Changes/Hour: 12 and 13
Photoperiod: 12-hour light/dark cycle
Acclimitization Period: 7 or 19 days
Food: Envigo Teklad Global Guinea Pig Diet #2040; 20 g/day
Water: Filtered tap ad libitum
IDENTIFICATION:
Each cage was identified with a cage card indicating at least the study number and the ID and sex of the animal.
Each animal was given a unique ID number that was attached via stainless steel ear tag.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.4 ml
- Day(s)/duration:
- Once (1) per week for three (3) weeks for six (6) hours each.
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.4 ml
- Day(s)/duration:
- Once (1) for six (6) hours.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary Irritation Group: 4
Test Group: 20
Naive Control Group: 10 - Details on study design:
- RANGE FINDING TESTS: A preliminary irritation test was peformed on 4 animials to determine the highest non-irritating concentration (HNIC). The HNIC selected for the challenge phase was 100%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals exposed once per week for 3 weeks.
- Control group: 1 group of 10 unexposed animals served as the naive control group.
- Site: left side
- Frequency of applications: Once per week
- Duration: 3 weeks
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27 days after first induction
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals exposed once
- Control group: 1 group of 10 animals
- Site: Right
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after challenge application
- Challenge controls:
- A group of 10 animals, unexposed during the induction phase, served as a naive control group. These control animals were exposed during the challenge phase the same as the test animals.
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Not applicable.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse findings observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse findings observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse findings observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse findings observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No indication of irritation and/or sensitization response following the induction or challenge phase exposures in any animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitizer in the Buehler test.
- Executive summary:
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2600 (2003) with 20 young adult male Hartley albino Guinea pigs, the test substance was non-irritating and produced no signs of a sensitization response in any of the animals tested. Therefore, the substance was determined to not meet the criteria for classification as a skin sensitizer.
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