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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:
From 1997-09-23 to 1997-10-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
OJ No. L383A, 29.12.92
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This in vivo skin sensitisation study was carried out before 10 May 2017, and that in compliance with EC B.6.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
430-710-1
EC Name:
-
Cas Number:
15290-77-4
Molecular formula:
C5H3F7
IUPAC Name:
1,1,2,2,3,3,4-heptafluorocyclopentane
Specific details on test material used for the study:
Batch No.: 9705-2A
Purity: 98.18 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England.
- Microbiological status of animals, when known:
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 317-405 g
- Housing: housed in groups of five in suspended metal cages with wire mesh floors
- Diet: vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC), ad libitum; Hay given weekly
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-24.0
- Humidity (%): 34-66
- Air changes (per hr): Ca. 15
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Alembicol D
Concentration / amount:
30% v/v / 0.1 mL
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% / 0.4 mL
Day(s)/duration:
six days after the injections
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
100%, 50% v/v
Day(s)/duration:
two weeks after the topical induction
No. of animals per dose:
Test: 10
Vehicle controls: 5
Details on study design:
RANGE FINDING TESTS:
Animals were pre-treated with an intradermal injection of Freund's complete adjuvant, 50 : 50 with water for irrigation (Ph.Eur.), approximately two weeks prior to the start of the preliminary investigations.
Intradermal injections concentrations: 0.1 % - 100% v/v
Typical application concentrations: 30 %, 50 %, 70%, 100 % v/v。
Maximum concentration not causing irritation affects in the preliminary study: 100%.

MAIN STUDY
A. INDUCTION EXPOSURE
- Induction intradermal injections - test animals:
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 20 x 40 mm area within the clipped area.
Injectables for the test animals were prepared as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation (Ph.Eur.).
2. Test item, 30% v/v in Alembicol D.
3. Test item, 30% v/v in a 50 : 50 mixture of Freund's complete adjuvant and Alembicol D.

- Induction topical application - test animals:
Six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.5 mL per site of 10% w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later a 20 x 40 mm patch of Whatman No. 3 paper was saturated with approximately 0.4 mL of test item, as supplied. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm"). This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.

- Induction - control animals:
Treated similarly to the test animals with the exception of the test substance was omitted from the intradermal injections and topical application.


B. CHALLENGE EXPOSURE
- Challenge - control and test animals:
The control and test animals were challenged topically two weeks after the topical induction application using test item, as supplied and 50% v/v in Alembicol D.
Hair was removed by clipping and ten shaving from an area on the left flank of each guinea-pig. A 20 x 20 mm patch of Whatman No. 3 paper was saturated with approximately 0.2 mL of HFCPA, as supplied and applied to an anterior site on the flank. The test item, 50% w/w in Alembicol D was applied in a similar manner to a posterior site. The patches were scaled to the flank for 24 hours under strips of “Blenderm" covered by “Elastoplast" wound round the trunk and secured with “Sleck".
- Evaluation: evaluated 24 and 48 hours after removal of the patches.


OTHER:
- Clinical signs: observed daily for signs of ill health or toxicity
- Bodyweight: recorded on Day 1 (day of intradermal injections) and on the last day observations were made of dermal responses to the challenge applications.
Challenge controls:
30% and 100%
Positive control substance(s):
yes

Results and discussion

Positive control results:
Hexyl cinnamic aldehyde (HCA): 10/10, 10/10 positive results obtained in two recent tests.
Benzocaine and mercaptobenzothiazole (MBT): 10/10, 9/10 positive results obtained in two recent tests.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% v/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% v/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100% v/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100% v/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% v/v
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% v/v
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% v/v
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% v/v
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of ill health or toxicity recorded
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Dose level:
50, 100% v/v
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: test material: HCA
Group:
positive control
Dose level:
83.33 and 40 % v/v
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: MBT
Group:
positive control
Dose level:
83.33 and 40 % w/v
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: MBT

Any other information on results incl. tables

Signs of irritation during induction:

Intradermal: Necrosis was recorded at sites receiving Freund' s Complete Adjuvant in test and control animals.Slight irritation was seen in test animals at sites receiving test item 30% v/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.

Topical: Slight erythema was observed in test and control animals.

Challenge: no dermal reactions observed

Bodyweight: No effects

Applicant's summary and conclusion

Interpretation of results:
other: Not classified.
Conclusions:
The test item did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test aniamals.
Executive summary:

This study was designed to assess the skin sensitisation potential of test item using the guinea-pig following EC B.6. Ten test and five control animals were used.

Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected: Intradermal injection: 30% v/v in Alembicol D; Topical application: As supplied; Challenge application: As supplied and 50% v/v in Alembicol D.

The test item did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test animals.