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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 January 2003 to 26 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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

other: Alpk:APfSD (Wistar-derived)

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight, macroscopic examination

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality observed

Body weight:

other body weight observations

Remarks:

All the males and 4 females gained weight during the study. One female lost weight throughout the study (-6,5% compared to initial bw) Mean body weights were increased at the end of the observation period.

Gross pathology:

no abnormalities at macroscopic examination.
One male had pelvic dilatation of the kidney and a speckled thymus. As these are common spontaneous findings they were considered incidental.

Other findings:

the tests substance stained the skin brown on all animals following application.
Signs of slight skin irritation were seen in all animals, but cleared by day 13.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose of 1,2,3,4-tetrachloro-hexafluorobutane is estimated to be in excess of 2000mg/kg to male and female.

Executive summary:

A group of five males and five female Alpk: APfSD (Wistar-derived) rats received a single dermal application of 2000 mg/kg of 1,2,3,4-tetrachloro-hexafluorobutane.

The animals were assessed daily for the following 14 days for any signs of systemic toxicity and their body weights were recorded at intervals during the study. At the end of the study all the animals were killed and examinated post mortem.

None of the animals died and there were no signs of systemic toxicity. All animals gained weight throughout the study. Signs of slight skin irritation were seen in three males and all females but it had completely resolved within 9 days. There were no macroscopic abnormalities at examination post mortem.

The acute dermal median lethal dose of 1,2,3,4-tetrachloro-hexafluorobutane is estimated to be in excess of 2000mg/kg to male and female.