Cyclopentene

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: 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.
Laboratroy 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

Test material information

Constituent 1

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)

Test animals

Species:

rat

Strain:

Wistar

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

Duration of treatment / exposure:

12 weeks

Frequency of treatment:

6 hours/day for 5 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 0.3, 0.9, 3.2 mg/l (vapour)
Basis:

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

Results and discussion

Results of examinations

Details on results:

CLINICAL SIGNS AND MORTALITY
no noticeable changes in appearance and behaviour.

BODY WEIGHT AND WEIGHT GAIN
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)

HAEMATOLOGY/CLINICAL CHEMISTRY
The haematological values and serum-enzyme activities (SGOT, SGPT, P .P) as well as the serum concentrations of urea, creatinine ,
bilirubin and glucose were within the physiological range and

URINANALYSIS
There was no significant change in the composition of the urine .

ORGAN WEIGHTS
None of the organ weights showed statistically significant differences among groups

GROSS PATHOLOGY / HISTOPATHOLOGY: NON-NEOPLASTIC
No histopathological changes were seen which could be attributed to the inhalation of cyclopentene .

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

> 3.2 other: mg/l

Sex:

male/female

2

Dose descriptor:

LOAEL

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