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Diss Factsheets

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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
The protocol required that the Hill Top Chambers® be secured with Vetrap®and Dermiform ® tape. However, on Study Day 22, Elastoplast tape was used at the request of the Study Director. This deviation did not affect the integrity of the study.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted prior to the requirement for the LLNA.

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
EC Number:
249-616-3
EC Name:
Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
Cas Number:
29420-49-3
Molecular formula:
C4HF9O3S.K
IUPAC Name:
potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot number 2 and 5

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature

FORM AS APPLIED IN THE TEST (if different from that of starting material)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc. (Kingston, New York)
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: At least 6 weeks of age
- Weight at study initiation: Average 537g for males, 429g for females
- Housing: The animals will be individually housed in polycarbonate cages with contact bedding. The cages conform to standards set forth in the Animal Welfare Act (with all amendments) and the Guide for the Care and Use of Laboratory Animals, National Academy Press, Washington, D.C., 1996.
- Diet (e.g. ad libitum): Teklad Certified Guinea Pig Diet #7006 will be provided ad libitum.
- Water (e.g. ad libitum): Tap water will be provided ad libitum via an automatic watering system.
- Acclimation period: Animals will be acclimated for a minimum of seven days prior to Study Day 1 in the room where the experiment will take place.
- Indication of any skin lesions: The treatment sites will be inspected for interfering lesions, irritation, or defects that would preclude the use of any of the animals. 0nly animals with healthy, intact skin will be used.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12:12 hour light:dark cycle
- IN-LIFE DATES: From: 27 December 2001 To: 2 April 2002

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
125 mg/mL (0.1 mL)
Day(s)/duration:
Study day 1
Route:
intradermal
Vehicle:
other: 1:1 water with 50% Freund's Complete Adjuvent
Concentration / amount:
125 mg/mL (0.1 mL)
Day(s)/duration:
Study day 1
Route:
intradermal
Vehicle:
other: 1:1 water with 50% Freund's Complete Adjuvent/sterile water
Concentration / amount:
125 mg/mL (0.1 mL)
Day(s)/duration:
Study day 1
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
0.5 g
Day(s)/duration:
Study day 7
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
0.5 g (33.3% test article/petroleum)
Day(s)/duration:
Study day 22 for 24 hours
No.:
#2
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
Males only: 0.5 g (33.3% test article/petroleum)
Day(s)/duration:
Study day 29 for 24 hours
No. of animals per dose:
Males: 10 treated, 5 controls
Females: 20 treated, 10 controls (Due to equivocal results, the female portion of the study was repeated. The data for the first 15 females is maintained in the raw data, but was not included in the report)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 intradermal injections, 1 epicutaneous application
- Exposure period: Injections on study day 1. Epicutaneous on day 7 for 24 hours
- Test groups: 10/sex
- Control group: 5/sex
- Site: 4 cm x 2 cm area on back/flank
- Frequency of applications: 3 intradermal injections on study day 1, 1 epicutaneous application on study day 7 for 24 hours
- Duration: 29 days
- Concentrations: 125 mg/mL intradermal injection (0.1 mL), 0.5g epiceutaneous application

B. CHALLENGE EXPOSURE
- No. of exposures: 1 for females and 2 for males; males were rechallenged, no rechallenge for females due to lack of positive results
- Day(s) of challenge: day 22 (challenge), day 29 (rechallenge)
- Exposure period: 24 hours
- Test groups: 10/sex
- Control group: 5/sex
- Site: 4 cm x 2 cm area on back/flank
- Concentrations: 0.5g (33.3% test article/petroleum)
- Evaluation (hr after challenge): 24 and 48 hours
Positive control substance(s):
yes
Remarks:
Hexyl cinnamic aldehyde and 2-Mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Female test group
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Female test group
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Male test group
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Male test group
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: Male test group
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: Male test group
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, there was no evidene of skin sensitization following treatment with the test article.
Executive summary:

The dermal sensitization potential of the test article was evaluated in the Maximization Test using male and female Hartley guinea pigs. This study was performed in accordance with GLP (1997). The study design was based on Maximization Test methods described in Dermatotoxicology, 5 ed. (1996). The test article was prepared in Sterile Water for Injection (vehicle for intradermal induction) or petroleum jelly (vehicle for epidermal induction and challenge) just prior to each dosing procedure. The test group (10 males and 20 females) received intradermal induction injections of 0.1 ml/site of a 1:1 mixture of Freund’s Complete Adjuvant (FCA):vehicle, 125 mg/mL test article in vehicle, and 125 mg/mL test article in 1:1 FCA/vehicle. A control group (5 males and 10 females) received the same induction treatment with the exclusion of test article. The epidermal induction of sensitization was conducted under occlusion with 0.5 g test article in vehicle (test group) one week after the intradermal induction and 24 hours after pre-treatment with 10% sodium dodecyl sulfate. The control group did not receive any treatment during the epidermal induction. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of 33.33% test article and vehicle only under occlusive dressing. Skin reactions were evaluated at 24 and 48 hours after removal of the dressing. One week after the first challenge, the males were rechallenged in a similar manner. The females were not rechallenged due to a lack of positive results. Positive controls (2-mercaptobenzothiazole and hexyl cinnamic aldehyde) were recently tested to confirm the validity of the experimental technique. Three control group males and one test group male were found dead on Days 9-11. These deaths were not associated with test article treatment. No erythema or edema was observed at any site in either the control or test article group females following the first challenge. No erythema or edema was observed at any site in either the control or test article group males following the rechallenge (0% responders). Based on the results this study, there was no evidence of skin sensitization following treatment with the test article.