Amphoteric Fluorinated Surfactant

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

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 403 (Acute Inhalation Toxicity)

Deviations:

no

Remarks:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Remarks:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EEC Methods for the Determination of Toxicity Method B.2 Directive 92/69/EEC

Deviations:

no

Remarks:

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

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Japan Agricultural Chemicals Regulation Laws 2-1-3 Notification 12-Nousan-8147 and Notification 13 Seisan 1739

Deviations:

no

Remarks:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Purity: 28 wt%

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 248 - 265 g (males), 182 - 234 g (females)
- Fasting period before study: No
- Housing: Except during exposure, animals were housed individually in solid bottom caging with bedding and nestlets as enrichment.
- Diet (e.g. ad libitum): Ad libitum except during exposure
- Water (e.g. ad libitum): Ad libitum except during exposure
- Acclimation period: 6 days

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

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The exposure chamber was constructed of glass (cylindrical). A polycarbonate baffle at the chamber inlet promoted uniform chamber distribution of the test atmosphere.
- Exposure chamber volume: 34L
- Method of holding animals in test chamber: During exposure, animals were individually restrained in perforated stainless steel cylinders with conical nose pieces. The restrainers were inserted into a polymethylmethacrylate faceplate attached to the exposure chamber so that the nose of each animal extended into the exposure chamber. On the day before the exposure, animals were placed in restrainers once for approximately 15 minutes to acclimate the animals to the restrainers.
- Source and rate of air: Chamber airflow was 14 L/min which provided at least 25 air changes per hour
- Method of conditioning air: Chamber oxygen concentration was 21%.
- System of generating particulates/aerosols: Chamber atmosphere was generated by aerosolization of the test substance in air with a nebulizer. The test substance was placed in a 500 mL Erlenmeyer flask (on a stir-plate with a mixing bar) and metered into the nebulizer with a console drive pump equipped with a piston. High-pressure air, metered into the nebulizer by a mass flow controller, carried the resulting atmosphere into the exposure chamber. The mass flow controller and the syringe infusion pump were controlled and monitored by an automated data system. Chamber concentrations of test substance were controlled by varying the test substance feed rate to the nebulizer.
- Method of particle size determination: Two samples to determine particle size distribution (mass median aerodynamic diameter, geometric standard deviation, and percent particles less than 1, 3, and 10 μm diameter) were taken during the exposure with a cyclone preseparator/cascade impactor and air sampler.
- Treatment of exhaust air: The test atmosphere was exhausted through a dry-ice cold trap followed by a charcoal/HEPA filter cartridge prior to discharge into the fume hood.
- Temperature, humidity, pressure in air chamber: 21°C, 81 – 87%%, pressure not reported. Relative humidity in the exposure chamber was outside the targeted parameters due to the test substance containing 36% water. The chamber environmental conditions were considered adequate for the conduct of the study, and the relative humidity values that were above the targeted maximum of 70% do not adversely affect the results or interpretation of this study.

TEST ATMOSPHERE
- Brief description of analytical method used: The atmospheric concentration of the test substance in the test chamber was determined by gravimetric analysis at approximately 30-minute intervals. Known volumes of chamber atmosphere were drawn from the sampling port through a 25 mm filter cassette containing a pre-weighed glass fibre (Type A/E) filter. The filters were weighed on a microbalance. The filter weights were automatically transferred to an automated data system, which calculated the chamber concentrations based on the difference between pre- and post-sampling filter weights divided by the volume of chamber atmosphere sampled. Gravimetric sample start- and stop-times for each sample were controlled and recorded by an automated data system. Upon completion of the exposures, sample results were transferred to a reporting and analysis system, which collated sample calculations. Because the test substance contained water and glycol solvent mixture, the gravimetric filters were placed in a desiccator overnight and weighed again the following day to determine the chamber concentration of the non-volatile ingredients in the exposure atmosphere.

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Two samples to determine particle size distribution (mass median aerodynamic diameter, geometric standard deviation, and percent particles less than 1, 3, and 10 μm diameter) were taken during the exposure with a cyclone preseparator/cascade impactor and constant flow air sampler.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The MMAD (GSD) was 3.2 μm (2.3) and 3.2 μm (2.2).

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Rats were exposed to a total atmospheric aerosol concentration of 5.6 ± 0.90 mg/L test substance (mean ± standard deviation) which contained 2.6 ± 0.31 mg/L non-volatile components (determined by wet and dry gravimetric filter weights, respectively).

No. of animals per sex per dose:

One group of 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days following exposures.
- Frequency of observations: Since the animals were restrained in nose-only exposure tubes and due to the dense atmosphere resulting from the high concentration of the test substance observations for clinical signs of toxicity could not be conducted during the exposure; however, animals were observed for mortality during the exposure. Animals were observed for mortality and clinical signs of toxicity immediately after they were removed from the restrainers following exposure. During the 14-day recovery period, all rats were observed each day for mortality and were observed for clinical signs of toxicity on test days 0, 1, 2, 3, 7, and 14.
- Frequency of weighing: Rats were weighed on test days 0, 1, 2, 3, 7, and 14.
- Necropsy of survivors performed: Yes, gross pathology.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.6 mg/L air

Based on:

other: total atmospheric concentration

Exp. duration:

4 h

Remarks on result:

other: gravimetric measurement

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.6 mg/L air

Based on:

other: non-volatile components

Exp. duration:

4 h

Remarks on result:

other: gravimetric measurement

Mortality:

No animals died.

Clinical signs:

other: One male demonstrated laboured breathing when the animals were removed from exposure chamber. All animals had their facial skin/fur stained with test article and this same clinical sign was also observed in 4/5 males and 4/5 females on the day after expos

Body weight:

The male who had laboured breathing after exposure lost 16% body weight on day 1 while the rest of the animals lost ≤ 9% body weight. All animals gained weight during the rest of the 14-day recovery period.

Gross pathology:

No gross lesions were present in the rats at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Official Journal of the European Communities (EEC Directive 93/21)

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
4-hr LC50 (rats) >5.6 mg/L total atmospheric concentration and >2.6 mg/L non-volatile components

Executive summary:

One group of 5 male and 5 female rats was exposed nose-only for 4 hours to a total atmospheric aerosol concentration of 5.6 ± 0.90 mg/L test substance (mean ± standard deviation) which contained 2.6 ± 0.31 mg/L non-volatile components (determined by wet and dry gravimetric filter weights, respectively).The aerosol size was determined twice for the atmosphere and the mass median aerodynamic diameter (MMAD) measured 3.2 μm (2.3) and 3.2 μm (2.2) [MMAD (GSD), geometric standard deviation]. All animals survived the 5.6 mg/L exposure and subsequent recovery period. One male had laboured breathing during clinical observation after animals were removed from exposure chamber. The male who had laboured breathing after exposure lost 16% body weight (BW) on day 1 while the rest of the animals lost ≤9% BW. All animals gained weight and did not show any test substance-related clinical signs on day 2 or during the rest of the 14-day recovery period. There were no gross findings for all animals at the scheduled necropsy. Under the conditions of this study, the 4-hour inhalation LC₅₀ for the test substance in male and female rats was >5.6 mg/L total atmospheric concentration and >2.6 mg/L non-volatile components.