3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 October 2017 to 2 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate

EC Number:

261-818-3

EC Name:

Potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate

Cas Number:

59587-38-1

Molecular formula:

C8H5F13O3S.K

IUPAC Name:

potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctane-1-sulfonate

Test material form:

solid

Details on test material:

Purity: 97.1%

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not classified for acute dermal toxicity in accordance with Regulation (EC) No 1272/2008 (CLP).

Executive summary:

The purpose of this study was to assess the acute toxicity of 1-Octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-, potassium salt when administered by the dermal route to rats, followed by an observation period of 14 days or more, depending on the occurrence of clinical signs of toxicity. In the Main Study, one group of ten Hsd:Sprague Dawley®SD®rats (5 males and 5 females) was treated with the substance by dermal route at a dose of 2000 mg/kg body weight.The animals were examined daily during the acclimatization period and viability and clinical signs were recorded. All animals were examined for clinical signs in the first 30 minutes after dermal application and 1, 2, 3 and 5 hours after on day 1 and once daily during test days 2-15.Administration area was also examined before administration and once daily from day 2 until the end of study. Body weights were recorded on day 1 (prior to administration) and on  days 8 and 15. All animals from the Main Study were necropsied and examined macroscopically. All animals survived until the end of the observation period. No clinical signs or local alterations (in administration area) were observed during the course of the study. Body weight was within the range commonly recorded in rats of this strain and age. No macroscopic findings were recorded at necropsy. Since no mortality was recorded after administration of the substance at the dose of 2000 mg/kg, the LD50 was found to be higher than the above-mentioned dose when administered by dermal route to rats, and therefore assignment of hazard statement is unnecessary.