Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 OCT 2015 - 8 FEB 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 FEB 1987

Deviations:

yes

Remarks:

The room temperature during the study was transiently outside the anticipated range (measured temperature 18.9 - 24.1°C). This minor transient deviation did not influence the integrity or outcome of the study.

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz (18 NOV 2014)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

sodium 1,5-dioxo-1,5-bis({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy})-3-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)pentane-2-sulfonate

EC Number:

700-541-9

Cas Number:

1472634-24-4

Molecular formula:

C27H34F15NaO12S

IUPAC Name:

sodium 1,5-dioxo-1,5-bis({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy})-3-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)pentane-2-sulfonate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Weight at study initiation: 267 - 271g (males), 210 - 221g (females)
- Housing: The rats were kept individually in type III Makrolon cages, with a shelter and a play tunnel, on softwood bedding material.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 24.1°C
- Humidity (%): 47.2 - 67.3%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 36 cm²
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residue of the test item was wiped off with a dry cloth.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single dermal administration of 2000 mg/kg
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 (5f / 5m)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, 15
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen.

Clinical signs:

other: No clinical signs of toxicity were observed. The application site was brownish stained in all rats after removal of the gauze patch and test item.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

Under the conditions of the present study, the test item revealed no acute toxic potential after single dermal administration in rats. The LD50 value is considered to be higher than 2000 mg/kg.

Executive summary:

Study design

This GLP study was performed according to the OECD Guideline for Testing of Chemicals 402: "Acute dermal toxicity" (adopted on February 24, 1987) and the Council Regulation (EC) No. 440/2008. The test item was applied to the skin of 5 female and 5 male rats at 2000 mg/kg (limit test) by single dermal administration for 24 hours followed by a 2 -week observation period. Mortality and clinical signs were monitored for at least 6 hours after start of exposure and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.

 

Results

No mortality occurred during the course of this study.

No clinical signs of toxicity were observed.

The body weight development was inconspicuous throughout the study.

The gross pathological examination revealed no organ alterations.

 

Conclusion

Under the conditions of the present study, the test item revealed no acute toxic potential after single dermal administration in rats. The LD₅₀ value is considered to be higher than 2000 mg/kg.