Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-815-3 | CAS number: 74-85-1
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published in peer reviewed literature, non-guideline animal experimental study. Predates implementation of GLP. Limitations in reporting but scientifically acceptable and otherwise adequate for assessment.
- Justification for type of information:
- N/A
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Single acute ethylene exposure (4 hrs) (following 3 day gavage pre-treatment with Arochlor 1254).
- GLP compliance:
- no
- Test type:
- other: LC50
- Limit test:
- no
Test material
- Reference substance name:
- Ethylene
- EC Number:
- 200-815-3
- EC Name:
- Ethylene
- Cas Number:
- 74-85-1
- Molecular formula:
- C2H4
- IUPAC Name:
- ethene
- Details on test material:
- - Name of test material (as cited in study report): ethylene
- Physical state: Gas
- Analytical purity: Purity not reported; described as highest purity
- No further data
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- other: Holtzman
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 170-250 g
- Weight at study initiation: No data
- Housing: 5 or 6 per cage
- Diet: Purina rat chow (Ralston Purina Co., St Louis, Mo, USA), ad libitum except during exposure
- Water: ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- No data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Animals were exposed using inhalation chambers as described by Leach (1963); modified to allow regulation of the interior temperature.
TEST ATMOSPHERE
- Brief description of analytical method used: Chamber concentrations were monitored using a gas chromatograph with a flame ionization detector and a 5 foot column of Porapak Q.
- Samples taken from breathing zone: no data - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gas chromatograph
- Duration of exposure:
- 4 h
- Concentrations:
- 10000, 25000, or 57000 ppm (11, 473, 28700 or 65400 mg/m3)
- No. of animals per sex per dose:
- 7
- Control animals:
- yes
- Details on study design:
- - Male rats were administered Aroclor 1254 (300 µmole/kg) via gavage, once daily for 3 days, prior to inhalation exposure to ethylene
- Animals were exposed on the 4th day for 4 hours
- Duration of observation period following administration: Animals were killed 24 hrs following exposure - Statistics:
- Dose-response data were analyzed using analysis of variance (ANOVA) where p <0.05 was considered significant.
Results and discussion
- Preliminary study:
- N/A
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 57 000 ppm
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortality at highest dose tested
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 65 400 mg/m³ air
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortality at highest dose tested
- Mortality:
- None (0/7) each dose level
- Clinical signs:
- other: None reported
- Body weight:
- Not reported
- Gross pathology:
- None done
- Other findings:
- N/A
Any other information on results incl. tables
The authors report that rats that were exposed to ethylene, but not pre-treated with Aroclor, showed no observable changes in the liver (no further detail or animal numbers reported).
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: other: EU (DSD)
- Conclusions:
- The acute inhalation toxicity (4 hour) of ethylene is >57000 ppm ( 65400 mg/m3 or 65.4 mg/L).
- Executive summary:
This study was not conducted with the intention of determining an LC50 value. However, acute toxicity via the inhalation route (4 hrs) was assessed following high dose exposure to ethylene at 10000, 25000, or 57000 ppm (11, 473, 28700 or 65400 mg/m3). In all cases exposure was preceded by 3 days gavage pre-treatment with Arochlor 1254.
No deaths occurred within the first 24 hrs in any dose group following exposure which suggests that the LC50 (4h) is greater than 57000 ppm (65.4 mg/L).
The authors report that rats that were exposed to ethylene, but not pre-treated with Aroclor, showed no observable changes in the liver.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
