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EC number: 206-556-2 | CAS number: 354-32-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study report was not finalized. Only a draft report is available
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trifluoroacetyl chloride
- EC Number:
- 206-556-2
- EC Name:
- Trifluoroacetyl chloride
- Cas Number:
- 354-32-5
- Molecular formula:
- C2ClF3O
- IUPAC Name:
- trifluoroacetyl chloride
- Details on test material:
- name: trifluoroacetylchloride
presentation: liquefied gas
batch number: KF 182701.D
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were inspected for signs of illness at the beginning of the acclimatization period. No abnormalities were detected.
73 male and 73 female rats were used. Except during their stay in the exposure chamber the animals had free access to food and water. Animal room condition: 17.5-24°C, 23-78% relative humidity, 12 hour light/12 hour dark, ventilation frequency 12-15 times/hour, hygienic procedures according to standart operating procedure.
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: dry nitrogen
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- no data
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The principal method of analysis was adapted from a published method for the analysis of chloroacetyl chloride. A known volume of the atmosphere from the exposure chambers was drawn through glass absorption tubes containing a sampling substrate coated ith 9-[(N-methylamino)methyl]anthracene (MAMA). TFAC reacts with MAMA to form the stable product N-(9-anthracenylmethyl)-2,2,2-trifluoro-N-methylacetamide (MAMA-TFA).
The analysed chamber concentrations of TFAC are presented in two formats:
- Data (in microg/l) based on the absolute amount of MAMA-TFA found by HPLC and the volume of air sampled.
- Data (in ppm) corrected for the efficiency of conversion of TFAC to extractable MAMA-TFA by multiplying the tube recovery results by a factor (0.6068) - Duration of treatment / exposure:
- The rats were repeatedly exposed to the test substance (TFAC), for a period of 6 hours each day on 5 consecutive days each week, over a period of 13 weeks.
- Frequency of treatment:
- The rats were repeatedly exposed to the test substance (TFAC), for a period of 6 hours each day on 5 consecutive days each week, over a period of 13 weeks.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.10 , 0.48 and 1.99 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 male and 10 female rats for each dose and as control.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Control rats received air only.
- Positive control:
- there is not positive control.
Examinations
- Observations and examinations performed and frequency:
- - Clinical signs: All signs of ill health, together with any behavioural change or response to treatment, were recorded for each animal individually, during all study period.
- Mortality and morbidity: further checks were made early in each working day and again in the afternoon to look for dead or moribund animals.
- Bodyweight: the weight of each rat was recorded daily beginning 1 week before the start of exposures. during the treatment period, the bodyweights were recorded before exposure on the day.
- Food consumption: the quantity of food consumed by each main study rat was recorded weekly, commencing 1 week before the start of dosing.
- Ophthalmoscopy examination: the eyes of all rats were examined once before the start of exposures and at week 13, using a Keeler indirect ophthalmoscope. - Sacrifice and pathology:
- - Sacrifice: following 13 weeks of exposure all rats were killed on the Monday and Tuesday following the last exposure in week 13 (Friday). The rats were killed by intraperitoneal injection of pentobarbitone sodium and exsanguinated from the brachial blood vessels.
- Pathology: A detailed post mortem macroscopic examination of main study rats was performed. The following organs were dissected from each rats and weighted: adrenals, brain, epididymides, heart, liver, lungs, kindneys, ovaries, pituitary, prostate, seminal vesicles, spleen, testes, thymus, uterus.
- Bone marrow: necropsy of samples of bone marrow from the tibia were performed.
- Tissue preservation: samples of organs/tissues were preserved and microscopic pathology was performed.
- Immunohistochemistry: Tissues from the respiratory tract were collected to performed immunohistochemical analysis for the determination of TFA-protein complexes. - Other examinations:
- Laboratory investigations:
-Sample collection: blood and urine samples were collected from all main stydy animals during week 13 of exposure. The haematological, blood biochemical and urinalysis investigations were performed for each animals. - Statistics:
- All statistical analysis were conducted separately for male and female rats. For all parameters, the analyses were carried out using the individual animal as the basic experimental unit.
Bodyweight data were analysed using weight gain. Food consuption data were analysed using cumulative cage totals.
The following sequence of statistical tests was used for bodyweight, clinical pathology and organ weight data:
If the data consisted predominantly of one particular value, the proportion of animals with values different from the mode was analysied by appropriate methods. Otherwise:
-Bartlett's test was applied to test for heterogeneity of variance between treatments.
-Analysis of variance was followed by Student's test and Williams' test for a dose-related response although only Williams' test was reported. The Kruskal-Wallis analysis were followed by the non-parametric equivalents of the "t" test and Williams' test.
Additionally, for organ weight data, analysis of covriance was carried out adjusting for the final bodyweight where the regression coefficient describing the linear relationship between organ weight and the covariate was significantly different from zzero at the 10% level. Where there was no such relationship, analysis of variance was performed on the unadjusted values. Significance testing was performed at 5% and 1% levels.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- There were no unscheduled deaths during the study.
There were no clinical signs indicative of a toxic or irritant effect attributable to exposure to TFAC.
Overall mean bodyweight gains and cumulative food consumption were similar to control values.
Investigation of haematology parameters revealed a lower mean platelet volume (MPV) for high and intermediate dose males and all female TFAC-teated groups. A higher platelet distribution width (PDW) was also noted for all groups (both sexes) exposed to TFAC. The toxicological significance of the apparent shift ion the platelet size is not known.
Blood biochemistry and urinalysis parameters investigated in Week 13 were unaffected by exposure to TFAC.
There was no treatment-related findings noted macroscopically at necropsy.
The microscopic pathological examination revealed changes in the lungs and tracheobronchial lymph nodes at the high and low exposure levels only. At the high dose level macrophage aggregation and inflammation were seen in the alveolar ducts, moderate perivascular lymphoid aggregates peribronchiolar lymphoid infiltration and/or prominent germinal centres were seen. In addition, prominent germinal centres and/or medullary plasmacytosis were seen in the tracheobronchial lymph nodes of rats exposed at low dose level.
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- < 0.1 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality and clinical signs: No mortality observed during the study. No clinical signs indicative of toxic or irritating responses were observed.
Bodyweights were not affected by the exposure to TFAC
No changes were observed in blood chemistry and urinalysis
Haematology showed a lower mean platelet volume at high and mid concentration males and in all female groups. Moreover, a higher platelet distribution width was also observed in both sexes from all treatment groups. The changes in platelet size were considered of doubful toxicological significance.
Organ weight: a small increase in lung weight was observed in the high concentration group.
Histopathology: macrophage aggregates, alveolar duct inflammation and perivascular lymphoid aggregates were observed at the high dose level. Granulomatous inflammation, perivascular lymphoid aggregations and peribronchiolar lymphoid infiltration and/or prominent germinal centres were detected at the low concentration level.
No treatment-related changes were observed at the intermediate concentration.
Applicant's summary and conclusion
- Conclusions:
- Exposure of rats over a 90-day period to the vapour of TFAC at 2 ppm caused a mild inflammatory response in the lungs consistent with the corrosive nature of this material. Signs of inflammation of similar severity were observed also at the lowest tested concentration, 0.1 ppm, but not at the mid concentration (0.48 ppm). This behaviour was tentatively related by the study director to the ability of TFAC to act as a hapten. The study director speculated that TFAC could mainly act as a hapten at the lowest concentration, whereas the corrosive properties could play a role in the inflammatory response observed at the highest concentration. However this interpretation can hardly explain the total absence of inflammatory changes observed at the mid concentration.
Exposure of rats over a 90-day period to vapour of TFAC at 0.1 ppm caused a predominantly lymphocytic local response in the lungs and local lymph nodes which may represent a reaction by the immune system not induced at higher exposure levels. Although there was no effect at 0.5 ppm, a no effect level was not established in this study because exposure at 0.1 ppm elicited an apparent immune response. - Executive summary:
The sub-chronic toxicity of TFAC was studied in a 90-day inhalation toxicity study in Sprague-Dawley rats. The animals (10/sex/dose) were exposed to 0, 0.1, 0.5 and 2 ppm TFAC for 13 weeks (6 h/day, 5 days/week). Clinical signs, food and water consumption, changes in body weight were recorded daily during the study period; ocular examination was performed before the exposure period and on the last day of exposure. Blood and urine samples were collected on week 13 for the performance of clinical chemistry, hematology and urine analyses. Organ weight, gross and microscopic pathology examinations were performed at the end of the exposure period.
No mortality or clinical signs indicating irritating responses were observed during the exposure period. No changes were observed in bodyweights and food consumption. Hematology showed a slight but statistically significant decrease in mean platelet volume (in males at ≥ 0.5 ppm and in females at all tested concentrations) and in platelet distribution width (in both sexes at all tested concentrations). Lymphocyte and basophile counts were statistically significantly lower in males at ≥ 0.5 ppm, resulting in a lower white blood cell count observed in those concentrations in comparison to control. Although statistical relevance was achieved, those changes were not dose-related. An increased lung relative weight was observed in females and males exposed to 2 ppm (statistical relevance attained in females only). The histopathological examinations revealed an increased incidence of macrophage aggregates, alveolar duct inflammation and perivascular lymphoid aggregates in both sexes exposed to the highest concentration (2 ppm). Similarly, increased incidence of perivascular lymphoid aggregation was observed in both sexes of the low exposure concentration group, but not in the mid exposure concentration group in comparison to control. Furthermore other changes related to inflammatory responses in the lung (alveolar duct granulomatous inflammation), bronchus (BALT-prominent germinal centres and peribronchiolar lymphoid infiltration) and tracheobronchial lymph nodes (prominent germinal centres and protomedullary plasmacytosis) were observed in the low exposure concentration group only.
Due to the results of the histopathological examinations, no NOAEC could be assigned to this study. It should be noted that the study has not been finalized and only a draft report is available.
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