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Toxicological information

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:
10 April 2000 to 12 May 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Appropriate testing and auditing guidelines were followed. Biological assessments were very clear allowing for easy assignment of classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A Guinea Pig Maximization Test was conducted prior to the requirement for the Local Lymph Node Assay.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
435-790-1
EC Name:
-
Cas Number:
297730-93-9
Molecular formula:
C9H5F15O
IUPAC Name:
3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl)hexane
Details on test material:
- Name of test material (as cited in study report:
T-7145
- Substance type: clear colorless liquid
- Physical state: volatile liquid
- Analytical purity: . 99.5%
- Lot/batch no.: Lot 4
- Expiration date of the lot/batch: 30 September 2000
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 5 weeks old
- Weight at study initiation: 400 grams average
- Housing: 5 animals per labelled metal cage with wire-mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5+ days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:10 April 2000 to 12 May 2000

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
No. of animals per dose:
10/5 (treated/controls)
Details on study design:
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 24
- Test groups: 0.15 mL test substance
- Control group: 0.15 mL vehicle
- Site: scapular
- Frequency of applications: one
- Duration: 24 hours
- Concentrations: neat
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours
- Test groups: One-10 animals
- Control group: one- 5 animals
- Site:flank
- Concentrations: neat
- Evaluation 24 and48 hours after challenge
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
neat
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects related to sensitzation were noted
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: neat. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects related to sensitzation were noted.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Not a skin sensitizer
Executive summary:

Guinea pigs were injected intradermally with a 100% concentration of HFE-7500 and epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone. Approximately 24 hours before the epidermal induction. Two weeks after the epidermal application all animals were challenged with test substance and vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. Therefore, HFE-7500 is not considered to be a skin sensitizer under the conditions of this study (T-7145).