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Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restriction.

Data source

Reference
Reference Type:
publication
Title:
Acute, Subacute and Subchronic Inhalation Toxicity of Cyclopentene
Author:
Kimmerle G., Thyssen J.
Year:
1975
Bibliographic source:
Int. Arch. Arbeitsmed. 34, 177-184

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
4 groups of rats (10/sex/dose) were exposed to cyclopentene for 12 weeks.
Laboratory examinations of blood and urine were carried out. At the end of the exposure period all animals were sacrificed and the internal organs were macroscopically and histologically examined.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopentene
EC Number:
205-532-9
EC Name:
Cyclopentene
Cas Number:
142-29-0
Molecular formula:
C5H8
IUPAC Name:
cyclopentene
Details on test material:
Analytical purity: 99.8 % (technical)
Specific details on test material used for the study:
Appearance: pale yellow liquid
Qualities: specific gravity=0.772/20°C, slightly water-soluble, readily soluble in alcohols, hydrocarbons and chlorinated hydrocarbons

Test animals

Species:
rat
Strain:
Wistar
Details on species / strain selection:
Not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 140-150 g
- Housing: housed in groups of 5 in cages
- Diet (e.g. ad libitum): ad libitum (Altromin standard diet)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 2°C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Remarks:
presumably whole body application
Vehicle:
not specified
Details on inhalation exposure:
- Subchronic study (12 weeks) - 4 groups of rats were exposed to concentrations of 0, 112, 317 or 1139 ppm.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
- The effective cyclopentene concentration in the air was determined usign gas chromatography.
- A measured volume (1 1/min) was passed through three connected bottles in a series, each charged with 30 mL carbon tetrachloride over a period of 40 minutes.
- The carbon tetrachloride solutions were combined in a 100 mL volumetric flask and the content of cylopentene was determined.
Duration of treatment / exposure:
12 weeks
Frequency of treatment:
6 hours/day for 5 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/L air
Remarks:
control
Dose / conc.:
0.3 mg/L air
Dose / conc.:
0.9 mg/L air
Dose / conc.:
3.2 mg/L air
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
Post-exposure period: no

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: one day before the end of the inhaltation test
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: one day before the end of the inhalation test
- How many animals: all
- Parameters checked: SGPT, SGOT, AP, bilirubin, urea, creatinine, glucose
URINALYSIS: Yes
- Time schedule for collection of urine: one day before the end of the inhalation test





Sacrifice and pathology:
GROSS PATHOLOGY: Yes
heart, lungs, liver, spleen, kidneys, adrenals, thyroid, thymus and gonads
HISTOPATHOLOGY: Yes
heart, lungs, liver, spleen, kidneys, adrenals, thyroid, thymus and gonads ,prostata, lymph nodes, brain, eyes aorta, thigh-muscle and sternal bone
Statistics:
Not specified

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No noticeable changes in appearance.
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No noticeable changes in body weight.
(Body weight gain (in g) at 12 weeks: males - 106 (0.3 mg/ml), 93 (0.9 mg/ml), 93 (3.2 mg/ml) vs. 97 in the control group; females - 26 (0.3 mg/ml), 27 (0.9 mg/ml), 23 (3.2 mg/ml) vs. 25 in the control group)
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
Haemotological values, serum-enzyme activities (SGOT, SGPT, P .P), urea, bilirubin, creatinine and glucose were within the physiological range.
Urinalysis findings:
no effects observed
Description (incidence and severity):
No significant change in the composition of the urine.
Behaviour (functional findings):
no effects observed
Description (incidence and severity):
No noticeable changes in behaviour.
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
None of the mean values of absolute or relative organ weights showed signfiicant differences among groups.
Gross pathological findings:
not examined
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No histopathological changes were observed that could have been attributed ot the inhalation of cyclopentene.
Histopathological findings: neoplastic:
no effects observed

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
> 3.2 other: mg/l
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Results of haemotological examinations

 concentrationmg/l  haemoglobing/100ml  RBC10^6/mm³  Thrombocytes 10^3/mm³ PVC %   Leucocytes              
           Total 10^3/mm³  Neutro-phils % Baso-phils%   Eosino-phils%  Lympho-cytes% Mono-cytes% 
 Males                    
 0  14.6 8.43  995  49  7.6  17  1  0  8   0
 0.3  14.4 8.45  1016  48  8.2  14  2  0  84  0 
 0.9  14.9 8.30  1003  50  5.8  18  1  0  81  0 
 3.2 14.4  34  980  48  79  16  1  0  83  0 
                     
 Females                    
 0  14.0 7.78  1063  60  5.5  17  1  0  82  0 
 0.3 14.3  7.93  1095  61  5.1  16  2  0  82  0 
 0.9  14.1 8.02  1066  58  5.8  15  2  0  83  0 
 3.2 15.0  8.51  1118  58  6.1  19  1  0  80  0 
                     

means of groups of 10 rats

Results of clinical chemistry examinations

 concentrationmg/l SGOT mU/ml  SGPTmU/ml  APmU/ml  Ureamg/100ml Creatinine mg/100 ml Glucose mg/100 ml  Bilirubin    mg/100 ml     
 Males                    
 0  30.7 18.1  22.6  55.0  0.88  86.5  0.18       
 0.3  33.6 21.1  239  56.1  0.95  86.6  0.10       
 0.9  28.5 17.0  212  58.1  0.85  85.0  0.10       
 3.2  28.1 18.5  218  51.5  0.90  89.6  0.14       
                     
 Females                    
 0  33.8 15.8  156  51.9  0.92  87.1  0.15       
 0.3  33.6 15.5  146  52.1  0.93  88.2  0.12       
 0.9  33.0 15.9  149  48.2 0.94  85.2  0.16       
 3.2  33.7 15.6  153   48.9 0.90  89.2  0.17       
                     
                     

means of groups of 10 rats

Absolute and relative organ weights

 Sex andconcentration (mg/l) Organ                            weights   Terminal body weight
   Thyroid Thymus  Heart  Lung  Liver   Spleen Kidneys  Adrenals  Gonads     
 Absolut organ weight (mg)                      
 Males                      
 0  10.1 140   718  1027  7565  393  1733  30.0  2886    252
 0.3  10.2  151  723  1051  8097  388  1810  29.6  2821    261
 0.9  10.7  145  705  1046  7128  386  1659  27.8  2986    213
 3.2  10.7  155  721  1026  7630  382  1794  30.1  2869    244
                       
 Females                      
 0  9.0  133  518  847  4974  292  1407  37.7  42.9    167
 0.3  9.1  150  535  881 4907   305  1418  35.8  44.5    168
 0.9  9.3  151  542  831  5105  290  1407  36.3  42.9    169
 3.2  9.4  142  515  851  4886  291  1386  36.4  41.0    701
                       
 Relative organ weight (mg/100 g bw)                      
 Males                      
 0  4.0  55  285  409  3003  157  689  11.9  1167    
 0.3  3.9  58  278  403  3095  149  693  11.3  1061    
 0.9  4.3  58  284  423  2970 155   666  11.2  1205    
 3.2  4.3  63  296  422  3121  157  717  12.3  1181    
                       
 Females                      
 0  5.4  80  310  488  2970 175   857  22.6  25.7    
 0.3  5.4  89  319  527  2925  182  841  21.3  26.5    
 0.9  5.5  89  321  493  3027  172  835  21.5  25.4    
 3.2  5.5  88  320  530  2981  180  832  22.7  25.8    

Applicant's summary and conclusion

Conclusions:
This study investigated the repeated dose toxicity of the test substance, cyclopentene, when administed to rats at concentrations of up to 1120 ppm for 12 weeks. The NOAEL was determined to be > 3.2 mg/L in both male and female Wistar rats.
Executive summary:

This study investigated the repeated dose toxicity of the test substance, cyclopentene, when administed to rats at concentrations of up to 1120 ppm for 12 weeks. The NOAEL and LOAEL weree determined to be > 3.2 mg/L in both male and female Wistar rats.

The 23 -week exposure of cyclopentene caused no noticeable changes in behvaiour, appearance or body weight. All parameters measured within the haemotological tests were within the physiological range and there were no changes to the composition of urine.

The NOAEL was both determined to be > 3.2 mg/L in both male and female Wistar II rats.