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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 Oct 2017 to 02 Nov 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

29 December 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Commission Directive 2001/59/EC, Annex VI

Version / remarks:

6 August 2001

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Regulation (EC) No 1272/2008 (CLP) and amending Regulation (EC) No 1907/2006 (REACH). Globally Harmonized System

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

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-tridecafluorooctanesulphonate

Test material form:

solid

Details on test material:

Purity: 97.1%

Specific details on test material used for the study:

Purity: 97.1%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Hsd: Sprague Dawley SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS S.L., Kreuzelweg 53, 5961 NM Horst, Netherlands
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks at treatment
- Weight at study initiation: 205 to 253 g at treatment
- Housing: Sighting Study: In groups of no more than five during acclimatization, and two during the study in Makrolon type-4 cages with Lignocel S8-15 sawdust bedding. Main Study: In groups of no more than five during acclimatization and during the study in Makrolon type-4 cages with Lignocel S8-15 sawdust bedding. Different types of material specific to this species were supplied to reduce stress, enhance well-being and improve behavior.
- Diet: Pelleted standard Teklad 2014C rat/mouse maintenance diet ad libitum (supplied by Envigo RMS, S.L., batch no. 070717MA, expiry date: 3 April 2018).
- Water: Tap water in bottles ad libitum.
- Acclimation period: From 6 to 14 days between the date of arrival and treatment start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 30 to 70
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

distilled

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 5 cm
- % coverage: 10%
- Type of band/wrap: gauze patch covered with hypoallergenic, microporous adhesive band and a gauze strip

REMOVAL OF TEST SUBSTANCE
- Washing: Any product remains were removed with distilled water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg
- Constant concentration used: yes
- For solids, paste formed: yes,test item was moistened with distilled water to ensure good contact with skin

Duration of exposure:

24 hours

Doses:

- Sighting Study: 2000 mg/kg
- Main Study: as no mortality was observed in the sighting study, 2000 mg/kg was adminstered in the main study.

No. of animals per sex per dose:

- Sighting Study: Two males and two females were treated
- Main Study: Five males and five females were treated

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Clnical signs: Once during the first 30 minutes and at 1, 2, 3 and 5 hours after administration on test day 1 and during days 2 to 15
- Local signs: Before administration and daily from days 2 to 15
- Viability / mortality were checked together with clinical signs. However, it was recorded twice a day using the Pristima system.
- Body weight: On study days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: All animals were sacrificed at the end of the observation period (day 15), by intraperitoneal injection of sodium pentobarbital. The animals were then examined macroscopically.

Results and discussion

Preliminary study:

In the sighting study two males and two females were treated by dermal route on a single occasion at 2000 mg/kg. There was no mortality, clinical signs or local alterations in the administration area. Body weight was within the range commonly recorded for this strain and age. As no mortality was observed, this dose was administered in the Main Study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study at the dosage level of 2000 mg/kg.

Clinical signs:

There were no clinical signs or local alterations in the administration site during the course of the study.

Body weight:

Body weight was within the range commonly recorded for this strain and age. However, there was a 0.1 and 1.2% body weight decrease in two females during the first week, which was recovered during the final week.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality was recorded in the acute dermal toxicity test. The LD50 was determined to be higher than 2000 mg/kg bw when administered by dermal route to rats, and therefore assignment of hazard statement is unnecessary.

Executive summary:

The acute dermal toxicity of the test substance was assessed according to OECD guideline 402 and GLP principles. In this study, initially, two males and two females Sprague Dawley (Sprague Dawley®SD®) rats were treated by dermal route on a single occasion at 2000 mg/kg under semi-occlusive conditions. After 24 hours the test substance was removed with distilled water. As no mortality was observed, this dose was administered in the main study. For the main study, five males and five females were treated on a single occasion at 2000 mg/kg. The observation period was 14 days. 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 were necropsied and examined Macroscopically. All animals from the main study survived until the end of the observation period. It was determined that body weight were within the range commonly recorded in rats of this strain and age. No clinical signs, local alterations (in administration area) and macroscopic findings were observed during the course of the study.

Since no mortality was recorded after administration of the tested 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.