3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl)-hexane

Skin sensitisation

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

Test material information

Constituent 1

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)

Induction

Induction 1

Route:

intradermal

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

100%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

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).