Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 October 2020 - 25 March 2021

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate

EC Number:

940-803-1

Molecular formula:

This is a multi-constituent susbstance there is no molecular formula or molecular weight range available

IUPAC Name:

Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate

Test material form:

liquid

Specific details on test material used for the study:

Batch number W19011506 JAN 18, 2019
Expiry date 15 January 2021
Purity ~30% active in water

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Healthy nulliparous and non-pregnant female RccHan™:WIST albino rats were obtained from Envigo RMS (UK) Ltd.

Sex:

female

Details on test animals or test system and environmental conditions:

Animals were housed inside a limited access rodent facility (Building F21, Room 044/045).
The facility was designed and operated to minimize the entry of external biological and
chemical agents and to minimize the transference of such agents between rooms.
The animal room was kept at positive pressure with respect to the outside by its own supply
of filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature
and relative humidity controls were set to maintain the range of 20 to 24C and 40 to 70%
respectively. Any minor deviations from these ranges would not have had an adverse effect
on the animals and would not affect the integrity or validity of the study. Artificial lighting
was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per
24 hours. Environmental parameters are archived with the departmental raw data.
Periodic checks were made on the number of air changes in the animal rooms. Temperature
and humidity were monitored daily.
Alarms were activated if there was any failure of the ventilation system, or temperature limits
were exceeded. A stand-by electricity supply was available to be automatically brought into
operation should the public supply fail.
The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each
cage contained a quantity of autoclaved softwood bark-free fiber bedding. Cages, food
hoppers, water bottles and bedding were changed at appropriate intervals.
The animals were allowed free access to a standard rodent diet (Teklad 2014C Diet). This
diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
Potable water taken from the public supply was freely available via polycarbonate bottles
fitted with sipper tubes.
Each cage of animals was provided with Aspen chew blocks or balls for environmental
enrichment. Chew blocks or balls were provided throughout the study and were replaced
when necessary. Each cage of animals was provided with a plastic shelter for environmental
enrichment, which was replaced at the same time as the cages.
Each batch of diet was analyzed routinely by the supplier for various nutritional components
and chemical and microbiological contaminants. Supplier’s analytical certificates were
scrutinized and approved before any batch of diet was released for use. The quality of the
water supply is governed by regulations published by the Department for Environment, Food
and Rural Affairs. Certificates of analysis were received routinely from the water supplier.
Certificates of analysis were received routinely from the supplier of the chew blocks or balls.
Since the results of these various analyses did not provide evidence of contamination that
might have prejudiced the study, they are not presented.
No other specific contaminants that were likely to have been present in the diet or water were
analyzed, as none that may have interfered with or prejudiced the outcome of the study was
known.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with
electric clippers taking care to avoid damaging the skin, exposing an area equivalent to
approximately 10% of the total body surface area.
The test item was applied by spreading it evenly over the prepared skin. The treatment area
was covered with porous gauze held in place with semi-occluded surgical tape encircled
firmly around the trunk of the animal.
Treatment in this manner was performed on Day 1 (day of dosing) of the study only.
At the end of the 24 hours exposure period the dressing was carefully removed and the
treated area of skin was washed with warm water (30 to 40°C), to remove any residual test
item.
A record of the weight of the formulation dispensed and the amount remaining after dosing
was made. The balance of these two weights was compared with the predicted usage as a
check that the doses had been administered correctly.
Formulations were stirred before and throughout the dosing procedure.

Duration of exposure:

24h

No. of animals per sex per dose:

1 or 2

Control animals:

not required

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths and no systemic response to treatment in any animal.

Other findings:

Bandage reactions were seen in animals 71 and 72 from Day 2, these reactions had resolved
by Day 7 and 4, respectively. No other dermal irritation was seen in any animals.

Applicant's summary and conclusion

Conclusions:

The acute median lethal dermal dose (LD50) to rats of Thetawet FS-8250 was demonstrated to
be greater than 2000 mg/kg body weight.
Thetawet FS-8250 is included in Category 5/Unclassified, according to the Globally
Harmonised System (GHS).