Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 August 1990 - 27 December 1990
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Internal: In line with OECD 406. Two exposure groups (60% PFOB and neat PFOB) was used with 10 animals in each group . Two control groups with 4 animals each was used.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed in 1990 before the LLNA method had been validated.

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromoheptadecafluorooctane
EC Number:
207-028-4
EC Name:
1-bromoheptadecafluorooctane
Cas Number:
423-55-2
Molecular formula:
C8BrF17
IUPAC Name:
1-bromo-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane
Test material form:
liquid
Specific details on test material used for the study:
Neat PFOB: Physical state/Appearance: Clear colourless liquidImagent LN (60% w/V PFOB):Physical state/Appearance: White liquidStorage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hra: (DH)SPF
Sex:
male/female
Details on test animals and environmental conditions:
Source: Hazleton Research Products, Inc.Age of animals at study initiation: Young adultWeight at study initiation: 350 to 550 gramsEnvironmental controls for the animal room was set to maintain a temperature of 72 deg F ± 6 deg F, a relative humidity of 50% ±20%, and a 12-hour light/12-hour dark cycle. Acclimation period: At least 7 days

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Concentration/amount used for induction: interdermal treatment 100% PFOB and Imagent LN (60% w/v PFOB), amount 2 x 0,05 ml of each; topical 100% PFOBConcentration Freunds Complete Adjuvant (FCA): interdermal 50% test substance in FCA, amount 2 x 0,05 ml; and 50% FCA in sterile water, amount 2 x 0,05ml
Day(s)/duration:
8 days
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
2 x 2 cm patch of undiluted PFOB
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test group per dose:10 animals Control group per dose: 10 animalsNaive control: 4 animals
Details on study design:
The study was conducted using 10 test animals and four naive control animals per test material. The positive control group consisted of ten animals.Induction phaseOn Day 1, animals in each test group received duplicate 0.05-mL intradermal injections of a mixture of Freund's Complete Adjuvant in sterile water, the respective test material, and a mixture of the respective test material in Freund's Complete Adjuvant. For the positive control group, the animals received duplicate 0.05-mL intradermal injections of a mixture of Freund's Complete Adjuvant in sterile water, a 5% w/ v suspension of sulfathiazole in sterile water, and a 5% w/ v suspension of sulfathiazole in Freund's Complete Adjuvant. On Day 7, animals in all three test groups and the positive control group were pretreated with 10% w/w sodium lauryl sulfate in petrolatum applied topically at the shaved area of the Day 1 intradermal injections. On Day 8, the respective test or positive control received a topical application. The respective undiluted test material was applied to saturation to a 2-cm x 4-cm patch of Whatman No. 3 filter paper and placed over the injection sites. The positive control animals received an application of a 25% w/w suspension of sulfathiazole in petrolatum. The patches were occluded and remained in place for approximately 48 hours. The naive control animals were not treated during the induction phase. Two weeks after the topical induction dose, all animals received a challenge dose. The respective undiluted test material was applied to saturation to a 2-cm x 2-cm Whatman No. 3 filter paper. The patch was applied to one site on the shaved right flank of each animal in each respective test or naive control group. The positive control animals were treated with a 10% w/w suspension of sulfathiazole in petrolatum. The sites were examined for erythema and edema at 24 and 4B hours following application.Induction phaseOn Day 1, animals in each test group received duplicate 0.05-mL intradermal injections of a mixture of Freund's Complete Adjuvant in sterile water, the respective test material, and a mixture of the respective test material in Freund's Complete Adjuvant. For the positive control group, the animals received duplicate 0.05-mL intradermal injections of a mixture of Freund's Complete Adjuvant in sterile water, a 5% w/ v suspension of sulfathiazole in sterile water, and a 5% w/ v suspension of sulfathiazole in Freund's Complete Adjuvant. On Day 7, animals in all three test groups and the positive control group were pretreated with 10% w/w sodium lauryl sulfate in petrolatum applied topically at the shaved area of the Day 1 intradermal injections. On Day 8, the respective test or positive control received a topical application. The respective undiluted test material was applied to saturation to a 2-cm x 4-cm patch of Whatman No. 3 filter paper and placed over the injection sites. The positive control animals received an application of a 25% w/w suspension of sulfathiazole in petrolatum. The patches were occluded and remained in place for approximately 48 hours. The naive control animals were not treated during the induction phase. Two weeks after the topical induction dose, all animals received a challenge dose. The respective undiluted test material was applied to saturation to a 2-cm x 2-cm Whatman No. 3 filter paper. The patch was applied to one site on the shaved right flank of each animal in each respective test or naive control group. The positive control animals were treated with a 10% w/w suspension of sulfathiazole in petrolatum. The sites were examined for erythema and edema at 24 and 48 hours following application.
Challenge controls:
No
Positive control substance(s):
yes
Remarks:
Sulfathiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
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:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
other: Naive control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Naive control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
other: Naive control
Dose level:
60% w/v
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Naive control
Dose level:
60% w/v
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
10
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No dermal reaction were observed in the test or naïve control animals treated with Imagent LN (60% PFOB) and sterilised neat PFOB. Dermal sensitisation responses were observed in animals treated with the positive control material.Imagent LN (60% PFOB) and sterilised neat PFOB were not a sensitiser in this test.