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Diss Factsheets

Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP; predates implementation of GLP and/or development of study guidelines but otherwise acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
Deviations:
not specified
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propene
EC Number:
204-062-1
EC Name:
Propene
Cas Number:
115-07-1
Molecular formula:
C3H6
IUPAC Name:
prop-1-ene
Constituent 2
Reference substance name:
Propylene
IUPAC Name:
Propylene
Details on test material:
purity >99.7%

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Frederick Cancer Research Centre
- Age at study initiation: weanling
- Weight at study initiation: mean bw per group for males 78-84 g; mean bw per group for females 60-63 g
- Fasting period before study: none
- Housing: Individually housed in stainless steel mesh cages
- Diet: Wayne Lab-Blox® (Allied Mills, Inc., Chicago, IL, USA); freely available except during inhalation exposure
- Water: tap water available ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: not reported
- Humidity: not reported
- Air changes: not reported
- Photoperiod: 12 hrs dark /12 hrs light

IN-LIFE DATES: From: 27 May 1977 To: 1 September 1977

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
All test chambers received clean, dry chamber supply air, 24 hours/day, at the top of each chamber. The test material was metered into the chamber air so that it was well mixed with incoming air by turbulence. A dual-bank switching type manifold (Matheson Gas Products, Joliet, IL, USA) provided a continuous supply of gas.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
only reported for 2-year studies
Duration of treatment / exposure:
14 weeks
Frequency of treatment:
6 hours/day, 5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 625, 1250, 2500, 5000 and 10,000 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
9-11/sex/group
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: day 0 and then weekly

FOOD CONSUMPTION: No

FOOD EFFICIENCY: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes. The following tissues were examined: gross lesions, skin, mandibular lymph node, mammary gland, salivary gland, thigh muscle, sciatic nerve, sternebrae, vertebrae or femur including marrow, costochondral junction (rib), thymus, larynx and pharynx, trachea, lungs and bronchi, heart, thyroid gland, parathyroids, oesophagus, stomach, duodenum, jejunum, ileum, colon, caecum, rectum, mesenteric lymph node, liver, pancreas, spleen, kidneys and adrenal glands, urinary bladder, seminal vesicles/prostate/testes or ovaries/uterus, nasal cavity and nasal turbinates, brain, pituitary gland, spinal cord, eyes.

HISTOPATHOLOGY: Yes on above tissues from all controls, high dose and early deaths
Statistics:
The probability of survival was estimated by the product-limit procedure of Kaplan and Meier (1958). Statistical analyses for a possible dose-related effect on survival used the method of Cox (1972) for testing two groups for equality and Tarone's (1975) life table test for a dose-related trend. All reported P values for the survival analysis are two-sided.
The incidence of lesions is given as the ratio of the number of animals bearing such lesions at a specific anatomic site to the number of animals in which that site was examined.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
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:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not specified
Details on results:
CLINICAL SIGNS AND MORTALITY: No compound related deaths or clinical signs were observed

BODY WEIGHT AND WEIGHT GAIN: The mean body weights of exposed male rats were 4%-12% higher throughout most of the study. Weight gains of exposed and control female rats were comparable. These differences were considered not to be dose related.

PATHOLOGY: No gross or microscopic pathologic effects (including no nasal cavity changes) were observed

Effect levels

Key result
Dose descriptor:
NOAEC
Effect level:
10 000 ppm (nominal)
Sex:
male/female
Basis for effect level:
other: ( 17,200mg/m3), no deaths or clinical signs, no dose-related effects on bodyweight, no abnormalities detected at macroscopic or microscopic examination

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
This study demonstrates that propene is not toxic to rats exposed to concentrations up to 10,000 ppm for 14 weeks. These findings are consistent with the available human data.
Executive summary:

Male and female Fischer 344 rats were exposed to gaseous prop-1 -ene for 6h/day 5 days a week for 14 weeks. After the exposure period, animal tissues were examined. No clinical signs or deaths were attribued to the compound. The mean body weights of exposed male rats were 4 -12% higher throughout most of the study, thr weight of exposed female rats was comparableto control females. The weight differences were not considered to be dose related.