Butane, 1,2,3,4-tetrachloro-1,1,2,3,4,4-hexafluoro-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 february 2003 to 20 June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(1998)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,4-tetrachloro-1,1,2,3,4,4-hexafluorobutane

EC Number:

938-148-1

Cas Number:

375-45-1

Molecular formula:

C4Cl4F6

IUPAC Name:

1,2,3,4-tetrachloro-1,1,2,3,4,4-hexafluorobutane

Details on test material:

- Name of test material (as cited in study report): A1112 Dimer
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 99% pure substance
- Isomers composition: not applicable
- Purity test date: not reported
- Lot/batch No.: DAD 619
- Expiration date of the lot/batch: 2005

- Storage condition of test material: ambient temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

mean score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

Mean score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Any other information on results incl. tables

There were no signs of ill-health in any animal during the study. The application site of one animal was stained by the test substance but this did not prevent the assessment of irritation.

There were no signs of irritation in one animal.

In two animals, very slight erythema and very slight oedema were seen approximately 1 hour after decontamination. very slight erythema was also seen in one of these animals 2 days after application. Additional signs of irritation consisted of desquamation in one animal and erythema beyond the application area of the other animal. All signs of irritation had completely resolved within 7 days of application.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

1,2,3,4-tetrachloro-hexafluorobutane is a slight irritant following a single four-hour application to rabbit skin.

Executive summary:

The purpose of this study was to assess the skin irritation potential of 1,2,3,4-tetrachloro-hexafluorobutane to rabbit, when administered by dermal application.

Three female rabbits each received a single four-hour application of 0.5 ml of 1,2,3,4-tetrachloro-hexafluorobutane to the shorn flank. The animals were assessed for up to 7 days for any signs of skin irritation.

There were no signs of irritation in one animal.

In two animals, very slight erythema and very slight oedema were seen approximately 1 hour after decontamination. Very slight erythema was also seen in one of these animals 2 days after application. Additional signs of irritation consisted of desquamation in one animal and erythema beyond the application area of the other animal. All signs of irritation had completely resolved within 7 days of application.

1,2,3,4-tetrachloro-hexafluorobutane is a slight irritant following a single four-hour application to rabbit skin.