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EC number: 919-006-8 | CAS number: -
Repeated dose toxicity: inhalation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- sub-chronic 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 is classified as reliable without restriction because it is in compliance with OECD guidelines, as well as U.S. EPA/FIFRA, U.S. EPA/TSCA, and EU guidelines.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it is in compliance with OECD guidelines, as well as U.S. EPA/FIFRA, U.S. EPA/TSCA, and EU guidelines.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA/FIFRA Guidelines §82-4
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.2450 (90-Day Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA/TSCA Guidelines 40 CFR §798.6059, and §798.6059, 798.6200, 798.6400
- Qualifier:
- according to guideline
- Guideline:
- other: EU Guideline 87/302/EEC
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not reported
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- not reported
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations were determined by gas chromatography.
- Duration of treatment / exposure:
- Rats were exposed to vapours of cyclopentane for 90 days.
- Frequency of treatment:
- 6 hours per workday
- Remarks:
- Doses / Concentrations:
5, 10, 30 (pure), 30 (technical) mg/L
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
5.0±0.2, 10.0±0.3, 29.8±1.5 (pure), 29.8±1.8 mg/L
Basis:
analytical conc. - No. of animals per sex per dose:
- 15 males and 15 females per dose group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- not reported
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: yes
- Time schedule: General observation were made twice on weekdays and once on weekends and holidays.
- Cage side observations were not included in a table.
DETAILED CLINICAL OBSERVATIONS: yes
- Time schedule: Clinical examinations were made once per weekday during preflow and the on the day following exposure.
BODY WEIGHT: yes
- Time schedule for examinations: measured weekly
FOOD CONSUMPTION: not reported
FOOD EFFICIENCY: not reported
WATER CONSUMPTION: not reported
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: yes
- Time schedule for examinations: Examinations were carried out prior to and following exposure.
- Dose groups that were examined: not reported
HAEMATOLOGY: Yes / No / No data: yes
- Time schedule for collection of blood: Examinations of numerous parameters were preformed at the end of the exposure period.
- Anaesthetic used for blood collection: not reported
- Animals fasted: not reported
- How many animals: 10 males and 10 females
CLINICAL CHEMISTRY: yes
- Time schedule for collection of blood: Examinations of numerous parameters were preformed at the end of the exposure period.
- Animals fasted: not reported
- How many animals: 10 males and 10 females
URINALYSIS: not reported
NEUROBEHAVIOURAL EXAMINATION: yes (neurofunctional tests)
- Time schedule for examinations: performed three times during the exposure period (approximately once per month)
- Dose groups that were examined: not reported
- Battery of functions tested: not reported - Sacrifice and pathology:
- A complete necropsy was performed on 15 animals per sex, which included weighing of selected organs and gross pathological evaluation.
5 animals per sex, of those subject to neurofunctional testing, were sacrificed by perfusion fixation and examined neuropathologically. - 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):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No abnormalities were detected during clinical, neurofunctional, and clinico-pathological examinations in any of the test groups. No changes were found during necropsy or in the histo- and neuropathological examinations.
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 30 mg/L air
- Basis for effect level:
- other: Equivalent to 30,000 mg/m3; 29.8 ± 1.5 (pure) or 29.8±1.8 (technical) mg/L air was the actual concentration
- Critical effects observed:
- not specified
- Conclusions:
- Subchronic inhalation exposure up to 30 mg/L of cyclopentane vapour (i.e, technical grade or high purity) did not cause a substance-related toxic effect. The NOAEC is 30 mg/L under the conditions of this study.
- Executive summary:
Fifteen male and 15 female Wistar rats per test group were exposed to cyclopentane vapour (pure) at concentrations of 5, 10, 30 mg/L and cyclopentane vapour (technical grade) at a concentration of 30 mg/L for 6 hours per weekday for 90 days. A concurrent control group was exposed to clean air. General observation were performed twice during weekdays and once during weekends and holidays. Clinical examinations were performed once every weekday and on the day following exposure. Neurofunctional test were performed in 10 animals per sex, once before the exposure period and three times during the exposure period. A hematological and clinicochemical examination was performed in 10 animals per sex at the end of the exposure period. A complete necropsy was performed on 10 animals per sex, which included weighing of selected organs and gross pathological evaluation. 5 animals per sex, of those subject to neurofunctional testing, were sacrificed by perfusion fixation and examined neuropathologically. Subchronic inhalation exposure to up to 30 mg/L of cyclopentane vapour (i.e., technical grade or high purity) did not cause a substance related toxic effect. The NOAEC is 30 mg/L under the conditions of this study.
This study was given a Kilimsh score of 1, reliable without restriction. The study had minor discrepancies that are listed in the overall remarks/attachments comment box in this robust summary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA/FIFRA Guidelines §82-4
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.2450 (90-Day Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA/TSCA Guidelines 40 CFR §798.6059, and §798.6059, 798.6200, 798.6400
- Qualifier:
- according to guideline
- Guideline:
- other: EU Guideline 87/302/EEC
- GLP compliance:
- not specified
Test material
- Details on test material:
- - Name of test material (as cited in study report): cyclopentane
- Substance type: C5 aliphatics
- Physical state: gas
- Analytical purity: Test groups were exposed to pure cyclopentane at concentrations of 5, 10, and 30 mg/L. One test group was exposed to technical grade (i.e., approximately 78% cyclopentane) at a concentration of 30 mg/L.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not reported
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- not reported
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations were determined by gas chromatography.
- Duration of treatment / exposure:
- Rats were exposed to vapours of cyclopentane for 90 days.
- Frequency of treatment:
- 6 hours per workday
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
5, 10, 30 (pure), 30 (technical) mg/L
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5.0±0.2, 10.0±0.3, 29.8±1.5 (pure), 29.8±1.8 mg/L
Basis:
analytical conc.
- No. of animals per sex per dose:
- 15 males and 15 females per dose group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- not reported
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: yes
- Time schedule: General observation were made twice on weekdays and once on weekends and holidays.
- Cage side observations were not included in a table.
DETAILED CLINICAL OBSERVATIONS: yes
- Time schedule: Clinical examinations were made once per weekday during preflow and the on the day following exposure.
BODY WEIGHT: yes
- Time schedule for examinations: measured weekly
FOOD CONSUMPTION: not reported
FOOD EFFICIENCY: not reported
WATER CONSUMPTION: not reported
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: yes
- Time schedule for examinations: Examinations were carried out prior to and following exposure.
- Dose groups that were examined: not reported
HAEMATOLOGY: Yes / No / No data: yes
- Time schedule for collection of blood: Examinations of numerous parameters were preformed at the end of the exposure period.
- Anaesthetic used for blood collection: not reported
- Animals fasted: not reported
- How many animals: 10 males and 10 females
CLINICAL CHEMISTRY: yes
- Time schedule for collection of blood: Examinations of numerous parameters were preformed at the end of the exposure period.
- Animals fasted: not reported
- How many animals: 10 males and 10 females
URINALYSIS: not reported
NEUROBEHAVIOURAL EXAMINATION: yes (neurofunctional tests)
- Time schedule for examinations: performed three times during the exposure period (approximately once per month)
- Dose groups that were examined: not reported
- Battery of functions tested: not reported - Sacrifice and pathology:
- A complete necropsy was performed on 15 animals per sex, which included weighing of selected organs and gross pathological evaluation.
5 animals per sex, of those subject to neurofunctional testing, were sacrificed by perfusion fixation and examined neuropathologically.
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):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No abnormalities were detected during clinical, neurofunctional, and clinico-pathological examinations in any of the test groups. No changes were found during necropsy or in the histo- and neuropathological examinations.
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 30 mg/L air
- Basis for effect level:
- other: Equivalent to 30,000 mg/m3; 29.8 ± 1.5 (pure) or 29.8±1.8 (technical) mg/L air was the actual concentration
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Subchronic inhalation exposure up to 30 mg/L of cyclopentane vapour (i.e, technical grade or high purity) did not cause a substance-related toxic effect. The NOAEC is 30 mg/L under the conditions of this study.
- Executive summary:
Fifteen male and 15 female Wistar rats per test group were exposed to cyclopentane vapour (pure) at concentrations of 5, 10, 30 mg/L and cyclopentane vapour (technical grade) at a concentration of 30 mg/L for 6 hours per weekday for 90 days. A concurrent control group was exposed to clean air. General observation were performed twice during weekdays and once during weekends and holidays. Clinical examinations were performed once every weekday and on the day following exposure. Neurofunctional test were performed in 10 animals per sex, once before the exposure period and three times during the exposure period. A hematological and clinicochemical examination was performed in 10 animals per sex at the end of the exposure period. A complete necropsy was performed on 10 animals per sex, which included weighing of selected organs and gross pathological evaluation. 5 animals per sex, of those subject to neurofunctional testing, were sacrificed by perfusion fixation and examined neuropathologically. Subchronic inhalation exposure to up to 30 mg/L of cyclopentane vapour (i.e., technical grade or high purity) did not cause a substance related toxic effect. The NOAEC is 30 mg/L under the conditions of this study.
This study was given a Kilimsh score of 1, reliable without restriction. The study had minor discrepancies that are listed in the overall remarks/attachments comment box in this robust summary.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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