2,2,3,3,4,4,5,5,6,6-decafluoro-6-trifluorovinyloxyhexanenitrile

Endpoint summary

Description of key information

The skin sensitization potential of MV5CN was evaluated in an in vivo study. The result of the study was:

Not sensitizing when tested according to OECD 406.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Version / remarks:

1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

This study was conducted prior to the development of the REACH regulation and the requirement for LLNA testing as the preferred in vivo method. The GPMT that was conducted was performed in compliance with OECD GLP according to OECD GL 406 and is adequate for hazard assessment and communication.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 3
- Purity.: 93.8%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness at approximately 5C in a refrigerator, light protected, under nitrogen
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: is acceptable for 4 hours
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): Solubolized in Tylose H 4000 G4 PHA for intradermal induction; unchanged for dermal induction
- Preliminary purification step (if any): No data
- Final concentration of a dissolved solid, stock liquid or gel: No data
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): Not applicable

FORM AS APPLIED IN THE TEST (if different from that of starting material) : 5% test article in Tylose H 4000 G4 PHA; unchanged for dermal induction

Species:

guinea pig

Strain:

other: HsdPoc:DH (Harlon)

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlon Winkelmann GmbH, Gartenstrasse 27, D33178 Borchen
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: No data
- Age at study initiation: No data
- Weight at study initiation: 321-415 g
- Housing: 5 animals per cage
- Diet: ad libitum
- Water: ad libitum)
- Acclimation period: at least 5 days
- Indication of any skin lesions: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20C
- Humidity (%): 50%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
- IN-LIFE DATES: From: 22 May 2001 To: 22 June 2001

Route:

intradermal

Vehicle:

other: Tylose 4000 G4 PHA

Concentration / amount:

5%

Day(s)/duration:

7 days

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%

Day(s)/duration:

48 hours

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100%

Day(s)/duration:

24 hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

10 (treatment), 5 (control)

Details on study design:

RANGE FINDING TESTS: Highest non-irritating concentration for dermal induction was 100% and for intradermal induction was 5% based on range finding study

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2; dermal and intradermal
- Exposure period: 9 days
- Test groups: 2 x 0.1mL of 5% test substance in Tylose H 4000 G4 PHA for intradermal induction and 0.5mL of 100% test substance for dermal induction
- Control group: 2 x 0.1mL of 100% Tylose H 4000 G4 PHA for intradermal induction and 0.5mL of 100% Tylose H 4000 G4 PHA for dermal induction
- Site: dorsal area
- Frequency of applications: Not applicable
- Duration: 9 days
- Concentrations: 5% for intradermal induction and 100% for dermal induction

B. CHALLENGE EXPOSURE
- No. of exposures: 1, dermal
- Day(s) of challenge: Study day 22
- Exposure period: 24 hours
- Test groups: 100% test substance
- Control group: 100% test substance
- Site: dorsal area
- Concentrations: 100% test substance
- Evaluation (hr after challenge): 24 hours

Positive control substance(s):

no

Key result

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

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

100%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

100%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

No skin reactions were observed in the control and the test groups during the challenge phase (0% response). Based on the results of this study, MV5CN is not classified for skin sensitization.

Executive summary:

The skin sensitization potential of MV5CN was evaluated in the Guinea Pig Maximization Test (GPMT). This study was performed in compliance with OECD GLP (1999). The test method was based on OECD 406 (1992), U.S. EPA OPPTS 870.2600 (1998), and Commission Directive 96/54/EC Annex IV C, Part B.6. A pre-test that used 5.0%, 1.0%, and 0.2% MV5CN diluted in Tylose H 4000 G4 PHA (vehicle) determined that 5.0% was the tolerant intradermal injection concentration for 2 female Harlan guinea pigs. Another pre-test on 3 animals determined that undiluted MV5CN was the primary non-irritant concentration. The validity of the test system is confirmed by a periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the maximization test. Each animal (5 females in control group, 10 in test group) received two intradermal injections within a dorsal area of 2 x 4 cm. These injection sites were left uncovered. Test group animals received the following intradermal injections: 50% Freund's Complete Adjuvant emulsion (mixed immediately before use), 5% MV5CN in Tylose H4000 G4 PHA, and 5% MV5CN in 50% Freund's Adjuvant. Control group animals received the same intradermal injections except that the vehicle replaced the 5% MV5CN. Seven days later, 0.5 mL of undiluted MV5CN (treatment group) or the vehicle (control group) was administered on a 2 x 4 cm cellulose patch to the site of the intradermal injection. This patch was then kept under an occlusive bandage, which was covered with an impermeable film and an elastic bandage for 48 hours. The occlusive bandage was removed after 48 hours, and any irritation was recorded. Animals were not treated with 10% SDS before dermal induction due to strong skin irritation reactions at the sites treated with Freund's Adjuvant. Fourteen days later, 0.5 mL of undiluted MV5CN was administered on a 2 x 2 cm cellulose patch to the left flank of each animal. The patch was kept under an occlusive bandage (as described above) for 24 hours, and then any remnants of MV5CN were washed off with warm water. Skin reactions (erythema and edema) were evaluated at 24 and 48 hours after removal of the dressing. Body weights and clinical observations were recorded. No changes in body weight or abnormal systemic clinical signs. Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. In addition, necrosis was observed at the injection sites treated with MV5CN in Freund's Adjuvant. The administration sites treated with MV5CN in Tylose H 4000 G4 PHA showed slight erythema and slight edema. Intradermal injections of the vehicle alone exhibited no signs of irritation. After the dermal induction treatment, the administration sites treated with MV5CN, or the vehicle alone showed no signs of irritation. No skin reactions were observed in the control and the test groups during the challenge phase (0% response). Based on the results of this study, MV5CN is not classified for skin sensitization.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Justification for classification or non-classification

Based on the result of the study, MV5CN is not classified as a skin sensitizer.