Reaction mass of bis(polysubstituted hexanoic acid) bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) diphosphate and bis(polysubstituted hexanoic acid) 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl phosphate and polysubstituted hexanoic acid bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen diphosphate and polysubstituted hexanoic acid bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate and polysubstituted hexanoic acid 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl hydrogen phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

TLF-11073

IUPAC Name:

TLF-11073

Details on test material:

- Purity: 22.82% solids in water

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 208.8 - 235.3 g
- Fasting period before study: yes; 16-16.5 hours prior to dosing
- Housing: singly in polycarbonate pans that contained bedding with enrichment (i.e., Shepherd's™ Cob + PLUS™).
- Diet (e.g. ad libitum): ad libitum except for fasting period prior to dosing; food was returned to the rats approximately 3-3.5 hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Air changes (per hr): Not Reported
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Maximum dose volume applied: Not Reported

Doses:

5000 mg/kg (corrected for percent solids (22.82%))

No. of animals per sex per dose:

3 female rats at a dose of 5000 mg/kg. The dose for each rat was corrected for percent solids (22.82%).

Control animals:

no

Details on study design:

- One rat was initially dosed. The remaining 2 rats were simultaneously dosed 2 days later.
- Duration of observation period following administration: 14 days
- Frequency of observations: at the beginning of fasting, just before dosing (test day 0), once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter.
-Frequency of weighing: on test days –1, 0, 7, and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

other: solids

Mortality:

No deaths occurred during the 14 days after dosing.

Clinical signs:

The rats exhibited no clinical signs during the 14 days after dosing.

Body weight:

No body weight losses occurred during the 14 days after dosing.

Gross pathology:

Gross discoloration of the lungs was observed in two of three rats. This is a non-specific finding and is common in rats of this strain and age.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 (female rats) > 5000 mg/kg, adjusted for purity (22.8% solids).

Executive summary:

A single dose of test substance was administered by oral gavage to 3 fasted female rats at a dose of 5000 mg/kg, adjusted for purity (22.8% solids). One rat was initially dosed. The remaining 2 rats were simultaneously dosed 2 days later. The rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. All rats were necropsied to detect grossly observable evidence of organ or tissue damage. No deaths occurred. The rats exhibited no clinical signs or body weight losses during the study.

Gross discoloration of the lungs was observed in two of three rats. This is a non-specific finding and is common in rats of this strain and age. No other gross findings were observed. Under the conditions of this study, the oral LD50 for the test substance was greater than 5000 mg/kg for female rats.