Sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 30, 2010 - Feb 01, 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to OECD TG 423.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate

EC Number:

700-540-3

Molecular formula:

C27H28F21NaO12S

IUPAC Name:

sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, KiBlegg
- Age at study initiation: 9 weeks (males) and 9 weeks (females)
- Weight at study initiation: 163g (150g - 175g)
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23 °C
- Humidity (%): 50 to 66 %
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methocel K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L and 30 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: excellent vehicle performance in long range historical data


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

Doses:

300, 2000 mg/kg

No. of animals per sex per dose:

@ 2000 mg/kg bw: 3 (m) / 3 (f)
@ 300 mg/kg bw: 3 (f)

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, and 15 of the experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All rats survived the observation period.

Clinical signs:

No signs of toxicity were seen in the 3 female rats treated with 300 mg/kg and the 3 male and 3 female rats after treatment with 2000 mg/kg bw .

Body weight:

The body weight development of the rats was inconspicuous during the study. In the femal rats treated with 300 and 2000 mg/kg the body weight development showed no constant linear increase as seen in males, but remained either the same or showed a reduction on individual days of the study.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.

Executive summary:

Study design

The test material was tested for acute toxicity in rats after single oral administration of 300 and 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 423 and according to Council Regulation (EC) No. 440/2008.

Results

No signs of toxicity were seen in the 3 female rats treated with 300 mg/kg and the 3 male and 3 female rats after treatment with 2000 mg/kg bw . The body weight development of the rats was inconspicuous during the study. In the femal rats treated with 300 and 2000 mg/kg the body weight development showed no constant linear increase as seen in males, but remained either the same or showed a reduction on individual days of hte study. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.

Conclusion

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD₅₀value is higher than 2000 mg/kg after single oral administration in rats.