Tetraethylammonium heptadecafluorooctanesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study according OECD 434 draft

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Principles of method if other than guideline:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semiocclusively for 24 hours. Mortality and clinical signs were examined during a 14 d post-observation period. analimals. After termination of the study a gross pathology was performed.

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Tetraethylammonium heptadecafluorooctanesulphonate

EC Number:

260-375-3

EC Name:

Tetraethylammonium heptadecafluorooctanesulphonate

Cas Number:

56773-42-3

Molecular formula:

C8H20N.C8F17O3S

IUPAC Name:

N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane-1-sulfonate

Details on test material:

tetraethylammonium perfluorooctesulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

dose mg/kg bw toxicological result*       occurrence of signs       time of death       mortality (%)

male

2000                     1/5/5                            8d-14d                            11d                     20

female

2000                      0/5/5                           2d-14d                            --                          0

* number of animals which died spontaneously and/or were sacrificed in moribund state / number of animals with signs of toxicity / total number of animals used per group

Clinical Signs

The following clinical signs were observed:

piloerection, sunken flanks, temporary clonical cramps and loss of weight in males,

a partial reddening of the test area and loss of weight in females

Body Weights

On day 8 of the study a severe loss of weight in all male animals was detected. At the end of the study all surviving male animals have had balanced the loss of weight.

A severe loss of weight in all female animals was detected. At the end of the study all females have increased the body weight but don’t have balanced the loss of weight.

The weights are given in the appendix as individual and mean values on page 24, for body weight gain see page 25.

Gross Pathology Findings

One male animal died on day 11 of the observation period.

The following changes were detected: liver and kidneys were light discolored.

The gross pathology investigations performed at the end of the post-treatment observation period in the surviving male animals and the females did not revealed any treatment-related findings

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information

Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semiocclusively for 24 hours. Mortality and clinical signs were examined during a 14 d post-observation period. analimals. After termination of the study a gross pathology was performed.

LD50 rat, male, female : > 2000 mg/kg body weight,

The following clinical signs were observed: piloerection, sunken flanks, temporary clonical cramps and loss of weight in males,

a partial reddening of the test area and loss of weight in females; one male animal died on day 11 of the observation period.

The following changes were detected: liver and kidneys were light discolored.

The gross pathology investigations performed at the end of the post-treatment observation period in the surviving male animals and the females did not revealed any treatment-related findings.

According to the OECD TG 434 for GHS a classification as Acute Tox 5, H313 (may be harmful in contact with skin). However, this classification for acute dermal toxicity has no relevance for EU countries, because in EU countries such an classification did not exist.