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EC number: 203-694-5 | CAS number: 109-67-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.07.1982-13.08.1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Fully documented, non GLP Study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Maximum test volume of 14.7 ml/kg body weight slightly exceeded the recommended maximum volume of 10 ml/kg for non-aqueous solutions. The weight of the animals was not recorded. The number of animals affected by symptoms of toxication is not specified.
- GLP compliance:
- no
- Remarks:
- Study too old. However, the study was found to be reliable based on criteria laid out in the TGD IR & CSA R4 (2008).
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Pent-1-ene
- EC Number:
- 203-694-5
- EC Name:
- Pent-1-ene
- Cas Number:
- 109-67-1
- Molecular formula:
- C5H10
- IUPAC Name:
- pent-1-ene
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Pentene-1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: Females: 56 - 62 days old; Males: 48 - 51 days old
- Weight at study initiation: Females: 129 - 147 g; Males: 129-147 g
- Fasting period before study: 16 h
- Housing: single
- Diet (e.g. ad libitum): Standardized feed for test animals ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Females: 2022, 2970, 4358, 6400, 9408 mg/kg (corresponding to 3.16, 4.64, 6.81, 10.0, 14.7 ml/kg)
Males: 2970, 4358, 5280, 6400 mg/kg (corresponding to 4.64, 6.81, 8.25, 10.0 ml/kg) - No. of animals per sex per dose:
- 5 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 960 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 486 - < 7 056
- Remarks on result:
- other: Range as indicated in the report, the statistical method is not given
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 597 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 732 - < 5 663
- Remarks on result:
- other: Range as indicated in the report, the statistical method is not given
- Mortality:
- FEMALES
2022 mg/kg: 0/5 animals died within 0.5h after ingestion
2970 mg/kg: 1/5 animals died within 0.5h after ingestion
4358 mg/kg: 2/5 animals died within 0.5h after ingestion
6400 mg/kg: 3/5 animals died within 0.5h after ingestion
9408 mg/kg: 5/5 animals died within 0.5h after ingestion
MALES:
2970 mg/kg: 0/5 animals died within 0.5h after ingestion
4358 mg/kg: 1/5 animals died within 0.5h after ingestion
5280 mg/kg: 3/4 animals died within 0.5h after ingestion and 1/4 died within 24 h after ingestion
6400 mg/kg: 5/5 animals died within 0.5h after ingestion - Clinical signs:
- other: - Locomotion decrease (narcotic effect) - staggering, labored breathing, inflated abdomen - higher dosages: inflation of whole body (generalized emphysema) due to intragastral evaporation of 1-pentene - premortal: decrease of muscle tone, general failure
- Gross pathology:
- - after canulation of the abdominal cavity and the subcutane connective tissue gas escaped which, from the smell, was identical with liquid 1-pentene
- hence, 1-pentene evaporation and penetration of the walls of the hollow organs and the abdominal cavity with subcutane accumulation was the explanation for this finding
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 for the registered substance is 2000 < Oral LD50 ≤ 5000 mg/ kg bw in male and female rats, therefore the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) but classified as ‘Category 5’ according to the GHS. Based on narcotic effects observed, the test material is classified as a specific target organ toxicant after single exposure, H336: May cause drowsiness or dizziness according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study performed similarly to OECD Guideline No. 401, groups of Wistar rats were administered a single oral dose of 1-pentene by gavage as followed:
Females: 2022, 2970, 4358, 6400, 9408 mg/kg (corresponding to 3.16, 4.64, 6.81, 10.0, 14.7 ml/kg)
Males: 2970, 4358, 5280, 6400 mg/kg (corresponding to 4.64, 6.81, 8.25, 10.0 ml/kg)
Animals were then observed for mortality and clinical signs during the 14-days observation period and at the end of the study the surviving animals were subjected to macroscopic examination.
As intoxication signs, primarily locomotion decrease (narcotic effect) and labored breathing were observed. Premortally, a decrease of muscle tone, general failure of reflexes, considerable inflation of the body and apnoea were observed. The inflation (emphysema) was similarly detectable in all dosing groups but graduated depending on dose. The course of intoxication was peracute.
Macroscopic-anatomically the internal organs of the deceased animals and the animals killed at the end of the observation period were not abnormal. Before laparotomy gas excaped after canulation of the inflated abdominal cavity and the subcutane connective tissue. The smell of the gas was the same as for 1 -pentene.
2000 < Rat Oral LD50 (combined) ≤ 5000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and classified as ‘Category 5’ according to the GHS. Based on narcotic effects observed, the test material is classified as a specific target organ toxicant after single exposure, H336: May cause drowsiness or dizziness according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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