Ammonium undecafluorohexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 - 24 Apr 2018

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

adopted in 2001

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium undecafluorohexanoate

EC Number:

244-479-6

EC Name:

Ammonium undecafluorohexanoate

Cas Number:

21615-47-4

Molecular formula:

C6H4F11NO2

IUPAC Name:

2,2,3,3,4,4,5,5,6,6,6-Undecafluorohexanoic acid, ammonium salt (1:1)

Test material form:

solid

Remarks:

White powder

Specific details on test material used for the study:

- storage: at room temperature in a shaded and air-tight container in a desiccator

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Remarks:

SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hino Breeding Centers (Charles River Laboratories), Hino, Japan
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 189.1 g (first sighting study), 193.2 g (second sighting study) and 196.3 – 200.0 g (main study)
- Fasting period before study: animals were fasted overnight prior to administration (17 – 19 h)
- Housing: Group housing of 4 females per cage in stainless steel cages (260 x 380 x 180 mm) with mesh-floor
- Diet: MF pelleted diet (Oriental Yeast), ad libitum
- Water: chlorinated tap water (chloric level maintained from 3 to 5 ppm by addition of sodium hypochloride (Purelox) to tap water), ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 Mar 2018 To: 24 Apr 2018

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Administration /exposure:
VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle: 10 mL/kg bw
- Lot/batch No.: PC171219

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION:
Dosing formulation was prepared freshly on each administration day. The test substance was weighed and mixed with purified water to be dissolved. The solution was filled up to the prescribed volume with purified water to prepare the dosing formulation. The dosing formulations were administered within one hour after the preparation.

Doses:

300 mg/kg bw
(300 mg/kg bw for 1st sighting, 2000 mg/kg bw for 2nd sighting)

No. of animals per sex per dose:

300 mg/kg bw: 5 (incl. sighting study)
2000 mg/kg bw: 4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality and clinical signs continuously for 10 min after the administration, 30 min and 3 h after the administration and once daily during Days 1 to 14 after the administration. Individual body weights were recorded before dose administration and 1, 7 and 14 days post-dose.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

300 mg/kg bw: 0/4 (main study), 0/1 (1st sighting study)
2000 mg/kg bw: 1/1 (2nd sighting study) within 24 h after administration

Clinical signs:

300 mg/kg bw: No clinical signs of toxicity were observed up to the end of the 14 day observation period
2000 mg/kg bw: decreased spontaneous locomotion, decreased respiratory rate, incomplete eyelid opening and moist hair (abdomen) in 1/1 animals 3 h after administration. Lacrimation was observed 5 h after administration.

Body weight:

One animal dosed at 300 mg/kg bw showed a low body weight gain of 4.5 g one day after administration. The effect was not considered toxicologically significant, because no abnormalities were observed in the general clinical observation or necropsy.

Gross pathology:

300 mg/kg bw: Necropsy and histopathological examination revealed no substance-related findings.
2000 mg/kg bw: edematous change of limiting ridge of the forestomach was observed

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

CLP: Acute Oral (4), H302