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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:
25 January and 23 February
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Remarks:
The bodyweight of a number of animals used was above the upper protocol weight range of 500 g at the start of the study, however, this was not considered to have affected the validity or integrity of the study.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
not specified
Remarks:
The bodyweight of a number of animals used was above the upper protocol weight range of 500 g at the start of the study, however, this was not considered to have affected the validity or integrity of the study.
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report: T-7499; Perfluorobutanesulfonyl fluoride
- Physical state: liquid/gas
- Analytical purity: 98%
- Lot/batch no.: not advised
- Expiration date of the lot/batch: April 26 2001
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin-Hartley , Albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:D.Hall, Newchurch,Staffs, UK.
- Age at study initiation: four to seven weeks of age on arrival
- Weight at study initiation: 441 - 580 g
- Housing: housed in groups of five in suspended metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum to a vitamin C enriched guinea-pig diet.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 degrees C.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal injection and topical application.
Vehicle:
other: Alembiocol D ( a coconut oil product, supplied by Alemic Products, Salthney, Chester, England
Concentration / amount:
10% v/v Alembicol D
Challengeopen allclose all
Route:
other: topical application
Vehicle:
other: Alembiocol D ( a coconut oil product, supplied by Alemic Products, Salthney, Chester, England
Concentration / amount:
10% v/v Alembicol D
Details on study design:
RANGE FINDING TESTS:Intradermal injections (0.1ml/site) were made into the clipped and shaved flank of two guinea pigs, using a range of concentrations (0.1 to 10% v/v) of the test article in a suitable vehicle (Alemibicol D). The resulting dermal responses were assessed approximately 24 and 72 houus later. Topical application occured by saturated patches of Whatman No.3 paper with 25% v/v to as supplied of the test article in the vehicle and applied to the clipped and shaved flanks of each of four guinea pigs. Patches were semiocclusive and dressings were removed after 24 hours of exposure. The reaction sites were assessed for erythema and edema. Further examination of the sites was carried out approximatly 24 and 48 hours after removal of the dressing.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs (intradermal)
- Exposure period: 48 hours
- Test groups: test animals 10 animals
- Control group: 5 control animals
- Site: Intradermal injections in the dorsal skin fo the scapular region
- Concentrations: 1% v/v in Alembicol D
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after topical induction
- Exposure period: 24 hours
- Test groups: 10 animals
- Control group: 5 control animals
- Site: left flank of each guinea pig
- Concentrations: 50% v/v test substance in Alembicol D and as supplied. .
- Evaluation (hr after challenge): 24 and 48 hours
Positive control substance(s):
yes

Results and discussion

Positive control results:
HCA produced evidence of skin sensitisation in all of the ten animals, confirming the sensitivity of the strain of animals and reliability of the expoerimental techinique

In vivo (non-LLNA)

Results
Reading:
other: The induction exposure caused slight irritation in test animals at sites receiveing the test article, 1% v/v in Alembicol D and slight irritaiton in control animals recieving Alembicol D after intradermal injection. After topical appliaction, slight eryth
Group:
other: all groups tested
Dose level:
1% v/v in Alembicol D for intradermal injection, as supplied for the topical application and as supplied and at 50% v/v in Alembicol D.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
The above number of animals are those that had a positive response after the challenge application of the test article. 7 of the 10 test animals showed slight erythema after topical application in the indu
Remarks on result:
other: see Remark
Remarks:
Reading: other: The induction exposure caused slight irritation in test animals at sites receiveing the test article, 1% v/v in Alembicol D and slight irritaiton in control animals recieving Alembicol D after intradermal injection. After topical appliaction, slight eryth. Group: other: all groups tested. Dose level: 1% v/v in Alembicol D for intradermal injection, as supplied for the topical application and as supplied and at 50% v/v in Alembicol D. . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The above number of animals are those that had a positive response after the challenge application of the test article. 7 of the 10 test animals showed slight erythema after topical application in the indu.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test article did not produce evidence of skin sensitization in any of the ten test animals. The test article is not considered to have to potential to cause skin sensitization. As all of the animals have negative responses, the test article does not require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Commission Directive 93/21/EEC
Executive summary:

This study was performed to assess the skin sensitization potential of the test article using the guinea-pig (OECD 406, EPA OPPTS 870.2600, EEC Annex to Directive 96/54/EC, Part B, Method B.6.). The guinea pigs were dosed by intradermal injection and topical application, as these are the routes of exposure required by the test guidelines and method. Based on results of a preliminary study and in compliance with the guidelines, the following dose levels were selected: 1% v/v in Alembicol D for the intradermal injection route; as supplied for the topic application; as supplied and 50% v/v in Alembicol D. Ten test and five-control guinea-pigs were used in this study. In this study, the test article did not produce evidence of skin sensitization in any way of the ten test animals. The test article does not require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Commission Directive 93/21/EEC.