1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methylbutane-1-sulphonamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 November 2001 to 27 December 2001

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:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EC Council Directive 67/548/EEC, Annex V, Part B

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: "Allergic Contact Dermatitis in the Guinea-Pig: Identification of Contact Allergens" Magnusson B. Kligman A.M., 1970 published by C.C. Thomas, Springfield, Illinois USA

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

This study was conducted prior to the requirement for the local lymph node assay.

Test material

Test material information

Constituent 1

Reference substance name:

T-7599

IUPAC Name:

T-7599

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): T-5799
- Substance type: White powder
- Analytical purity: >99.9% 1-Butanesulfonamide, 1, 1, 2, 2, 3, 3, 4, 4, 4-Nonafluoro-n(2-Hydroxyethyl)-N-Methyl-; <0.1% Methylamine
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 07 August 2002
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Approx. 4 weeks old
- Weight at study initiation: 290-321g ( mean 312g in control group); 302-346 g (mean 320g in experiemental group)
- Housing: Group housing of 5 animals per labelled metal cage with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 fluorescent light/12 dark

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

polyethylene glycol

Induction 2

Concentration / amount:

Intradermal induction exposures: 5%
Epidermal challenge: 20%

Challenge

Challenge 1

Route:

epicutaneous, semiocclusive

Vehicle:

polyethylene glycol

Challenge 2

Concentration / amount:

Intradermal induction exposures: 5%
Epidermal challenge: 20%

No. of animals per dose:

10 experimental animals, 5 control animals.

Details on study design:

RANGE FINDING TESTS:
100%, 50%, 20%, 10%, 5%, 2%, 1% test concentrations were administered via intradermal and epidermal application using 4 animals. This test procedure was identical to the procedure used in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:Two
- Exposure period: 48 hours
- Test groups: 2 animals
- Site: clipped scapular region
- Frequency of applications: Single
- Duration: 48 hours
- Concentrations: 20%, 10%, 5%, 2%
B. CHALLENGE EXPOSURE
- No. of exposures:2 per animal
- Day(s) of challenge: 2 days
- Exposure period: 48 hours
- Test groups: 4 animals
- Site: clipped scapular region
- Concentrations:2%, 5%, 10% and 20%
- Evaluation (hr after challenge): 48 hours

Challenge controls:

alpha-hexylcinnamic aldehyde

Positive control substance(s):

yes

Remarks:

alpha-hexylcinnamic aldehyde

Results and discussion

Positive control results:

Female guinea pig of the albino Dunkin Hartley strain is an appropriate model for the performance of studies designed to evaluate the sensitising potential of a substance in a Maximisation test.

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No abnormal clinical signs were observed upon challenge.

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0%

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

No abnormal clinical signs observed upon challenge.

Remarks on result:

no indication of skin sensitisation

Results 3

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

5%

No. with + reactions:

10

Total no. in group:

10

Remarks on result:

positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There was no evidence that the test article had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of zero percent. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test article does not have to be classifed and has no obligatory labelling requirement for sensitisation by skin contact.

Executive summary:

This study was carried out based on the guidelines in the EC Commission Directive 96/54/EC, Part B.6 and OECD number 406 and EPA OPPTS 870.2600. The test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 20% concentration of the test substance. Five control animals were similarly treated with the vehicle (polyethylene glycol) alone. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application, all animals were challenged with a 20% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that the test article had caused skin hypersensitivity in the guinea pig, since no response were observed in the experimental animals in the challenge phase. This result indicates a sensitization rate of zero percent. Based on these results and according to the EC criteria for classification and labeling requirements for dangerous substances and preparations, the test article does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact.