Trifluoroiodomethane

Endpoint summary

Description of key information

Two acute toxicity studies via inhalation are available. Based on the key study, a discriminating concentration of 20969 ppm is derived.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 Nov 2018 to 23 Nov 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

2009

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

1998

GLP compliance:

yes

Test type:

traditional method

Limit test:

yes

Specific details on test material used for the study:

Test substance identification: Trifluoroiodomethane (CF3I)
Batch #: BH136-100-17-10
Date received: July 12, 2018
Composition: CF3I – 100% w/w; CAS #2314-97-8
Physical Description: Colorless liquified clear gas
Expiration Date: Not applicable.

Species:

rat

Strain:

Sprague-Dawley

Remarks:

albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAGE® Labs
- Age at study initiation: Young adult (10-11 weeks)
- Weight at study initiation: males 336-379 grams and females 221-232 grams
- Housing: group housed, except on the day of exposure, at which time they were singly housed and until the animals were deemed acceptable, based on observations, to return to group housing. Enrichment (e.g., toy) was placed in each cage
- Diet: Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum, except during the exposure.
- Water: Filtered tap water was supplied ad libitum, except during the exposure.
- Acclimation period: 23 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 32 - 57
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 9 Nov 2018 To: 23 Nov 2018

Route of administration:

inhalation: gas

Type of inhalation exposure:

whole body

Vehicle:

clean air

Remarks:

Filtered mixing

Details on inhalation exposure:

TEST SUBSTANCE
The test substance as received was a gas. The test substance was introduced into the chamber directly from the compressed cylinder provided by the Sponsor.

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The exposure chamber, air supply, and equipment used to measure airflow and chamber concentration were the same as used during the appropriate pre-test trials and are described generally below.
- Exposure Chamber: Rectangular whole body Plexiglas® chamber with a volume of 100 litres. Animals were individually housed in elevated stainless steel caging during exposure.
- Air Supply: Filtered mixing air was supplied to the inhalation chamber by an air compressor, and measured with a Mass Flow Controller. This air was introduced into the chamber to help uniformly distribute the test atmosphere by creating a vortex at the chamber inlet. Chamber airflow was monitored throughout the exposure period and recorded periodically. The exposure was conducted under slight negative pressure.
- Ambient Conditions: The temperature and relative humidity within the exposure chamber as well as the room were monitored continuously during exposure, and were measured with a temperature-humidity monitor. Temperature and relative humidity values were recorded every 15 minutes for the first hour of exposure and approximately every 15 or 30 minutes thereafter. Oxygen was monitored continuously during the exposure. The measurements were measured with Oxygen Monitor (Crowcon Tetra Gas Monitor device).
- Atmosphere Generation: The test atmosphere was generated using a regulator connected to a Mass Flow Meter attached to the pressurized gas cylinder containing the test substance.
- Exposure Period: The animals were exposed to the targeted chamber concentration for at least 4 hours. The exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium (T99). At the end of the exposure period, the generation was terminated and the chamber was operated for at least 15 minutes further with clean air to allow the test atmosphere to fully dissipate. At the end of this period the animals were removed from the exposure chamber. Prior to being returned to their cages, excess test substance was removed from the fur of each animal by rinsing with tap water and wiping with clean paper towels.

TEST ATMOSPHERE
Samples were withdrawn at several intervals from the breathing zone of the animals. Samples were collected using a SGE 500 mL syringe attached to the chamber. A known volume of atmospheric air was drawn from inside of the chamber using the syringe. Each collected sample was subsequently injected into a 20 mL headspace vial directly from the syringe. The collected samples were analysed for % active ingredient.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

20969 ppm

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

SELECTION OF ANIMALS
On the day of and prior to exposure, the rats were examined for health and weighed. Ten healthy, naive rats (five males and five females; not previously tested) were selected for test.

BODY WEIGHTS
Individual body weights of the animals were recorded prior to test substance exposure (initial) and again on Days 1, 3, 7, and 14 (terminal).

CAGE-SIDE OBSERVATIONS
All animals were observed for mortality during the exposure period. The animals were examined for signs of gross toxicity, and behavioural changes upon removal from the exposure chamber and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, and coma.

NECROPSY
All rats were euthanized via CO2 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Statistics:

Statistical analysis was limited to the calculation of the mean and standard deviation.

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 20 969 ppm

Based on:

test mat.

Exp. duration:

4 h

Mortality:

All animals survived exposure to the test atmosphere.

Clinical signs:

other: Following exposure, all rats exhibited irregular respiration. However, the animals recovered by Day 1 and appeared active and healthy for the remainder of the 14-day observation period.

Body weight:

All animals gained body weight during the study.

Gross pathology:

No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Chemical analysis of the test atmosphere

The calculated chamber and nominal chamber concentrations were 20969 ppm and 27712.73 ppm, respectively.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the single exposure acute inhalation LC50 of Trifluoroiodomethane (CF3I) is greater than 20969 ppm in male and female rats.

Executive summary:

An acute inhalation toxicity test was conducted with rats to determine the potential for Trifluoroiodomethane (CF3I) to produce toxicity from a single exposure via the inhalation (whole body exposure) route, according to OECD 403 and in compliance with GLP. After establishing the desired generation procedures during the pre-test trials, ten healthy rats (5/sex) were exposed to the test atmosphere for 4 hours. Chamber concentration of the test atmosphere was determined periodically during the exposure period. The animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days following exposure. Body weights were recorded prior to exposure (initial) and again on Days 1, 3, 7, and 14. Necropsies were performed on all animals at terminal sacrifice.

All animals survived exposure to the test atmosphere and gained body weight during the study. Following exposure, all rats exhibited irregular respiration. However, the animals recovered by Day 1 and appeared active and healthy for the remainder of the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Under the conditions of this study, the single exposure acute inhalation LC50 of Trifluoroiodomethane (CF3I) is greater than 20969 ppm in male and female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

168 018 mg/m³ air

Quality of whole database:

The study is a guideline study in compliance with GLP.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Two acute studies are available on the substance. The recent study by Product Safety Labs (2018) is designated as the key study. The study by Dodd (1997) is included as supporting information.

Acute toxicity via inhalation (Key study; OECD 403)

An acute inhalation toxicity test was conducted with rats to determine the potential for Trifluoroiodomethane (CF3I) to produce toxicity from a single exposure via the inhalation (whole body exposure) route, according to OECD 403 and in compliance with GLP. After establishing the desired generation procedures during the pre-test trials, ten healthy rats (5/sex) were exposed to the test atmosphere for 4 hours. Chamber concentration of the test atmosphere was determined periodically during the exposure period. The animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days following exposure. Body weights were recorded prior to exposure (initial) and again on Days 1, 3, 7, and 14. Necropsies were performed on all animals at terminal sacrifice.

All animals survived exposure to the test atmosphere and gained body weight during the study. Following exposure, all rats exhibited irregular respiration. However, the animals recovered by Day 1 post-exposure and appeared active and healthy for the remainder of the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Under the conditions of this study, the single exposure acute inhalation LC50 of Trifluoroiodomethane (CF3I) is greater than 20969 ppm in male and female rats.

Acute toxicity via inhalation (Supporting study; no guideline)

A traditional acute inhalation toxicity study was performed in male Fischer-344 rats (Dodd, 1997). In this study three groups of 30 rats each were exposed to 0, 0.5 and 1% (v/v) test substance for 4 hours (nose only). Ten (10) animals of each group were euthanized immediately following exposure and 3 or 14 days post-exposure. Records of signs of toxicity and body weights (prior to exposure and Days 1, 3, 7, and 14 post-exposure) were maintained. At termination, gross pathology was performed on all animals, and tissues (nasal cavity, trachea, lungs, heart, liver, spleen, thyroid glands, parathyroid, kidneys, adrenal glands, and gross lesions) were harvested for histopathological examination. Blood was drawn for haematology and clinical chemistry assays that included red blood cell count, haemoglobin, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, haematocrit, total and differential leukocyte count, total protein, albumin, globulin, alanine aminotransaminase (ALT), aspartate aminotransaminase (AST), thyroxine (T4), and thyroxine binding globulin. No mortalities occurred and no signs of toxic stress were observed. In addition, no effects on body weight and macroscopic nor microscopic pathological parameters were observed. Although some statistically significant differences in haematologic and serum chemistry parameters were observed, these were considered of no toxicological relevance. Based on these results a discriminating concentration of 10,000 ppm is derived, which is the highest dose tested.

Justification for classification or non-classification

Based on the available information, classification and labelling for acute inhalation toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.