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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study. But full details not available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study dates from 2001 before the preferred method for REACH was LLNA.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
3,3,4,4,5,5,6,6,6-nonafluorohexene (PFBE) supplied by DuPont
Colour: colourless
Consistency: liquid
Odour: ether-like
Boiling point: 58°C
Relative density: 1.4 kg/l

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: No information
- Weight at study initiation: <500g
- Housing: in pairs in Makrolon cages (Type IV)
- Diet (e.g. ad libitum): Altormin GmbH D-32791 Lage/Lippe ad libitum
- Water (e.g. ad libitum): drinking water ad libitium
- Acclimation period: No information

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): No information
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: No information

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% PFBE
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% PFBE
No. of animals per dose:
10 (5 controls)
Positive control substance(s):
yes
Remarks:
2% Benzocain solution

Results and discussion

Positive control results:
The positve control data are obtained from historical background data of this laboratory. The possible control group is not tested concurrently with this study but is a historical background data group from a study performed during April/May 2000. The positive control group comprised 10 animals.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2 ml of 100% PFBE
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Behaviour unchanged
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
2 ml 100% PFBE
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Behaviour unchanged

Any other information on results incl. tables

Results of the Preliminary Study

In a preliminary study no skin reactions were noted after topical application with or without depilation, the intracutaneous injection caused a moderate and confluent erythema 24 to 72 hrs after treatment.

Hence, it was decided to use a 100% concentration of ZONYL® PFBE for the 1st (intracutaneous) induction stage, the 2nd (topical) induction stage and the challenge.

Main Study

A 100% concentration of ZONYL® PFBE chosen for the 1st (intracutaneous) induction stage produced a discrete or patchy erythema (grade 1 ) and a moderate and confluent erythema (grade 2), 25 and 48 hours after application in all animals, respectively. The skin was coated with sodium laurylsulfate one day before stage 2 (topical) induction (day 6 after the first induction) in order to induce a local irritation as the preliminary test revealed no irritating potential for a 100% concentration of ZONYL® PFBE. A moderate and confluent erythema was noted in all animals 49 and 72 hours after stage 2 induction (day 7 after the first induction) with a 100% concentration of ZONYL® PFBE . The challenge on day 23 with 2 ml ZONYL® PFBE/animal ( 100% concentration) revealed no skin irritation in any of the animal tested. Hence, ZONYL® PFBE had no sensitising properties for the depilated skin. Aqua ad iniectabilia (control) employed during the challenge stage 3 revealed no skin reactions per se. Animals of this strain treated with Benzocaine exhibited a sensitising reaction in all of the animals in the form of a discrete or patchy erythema (grade 1). The body weight gain of the animals treated with ZONYL® PFBE was within the range of the control during the experiment. No adverse effects on behaviour were observed.

Conclusion

In the main test on guinea pigs carried out in accordance with OECD Guideline 406, according to Magnusson and Kligman, PFBE did not exhibit a skin sensitising effect.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a test on guinea pigs carried out in accordance with OECD Guideline 406, according to Magnusson and Kligman, PFBE did not exhibit a skin sensitising effect.
Executive summary:

In a test on guinea pigs carried out in accordance with OECD Guideline 406, according to Magnusson and Kligman, PFBE did not exhibit a skin sensitising effect.