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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study adhered to the principles outlines in OECD 423 guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
Only summary information was provided. Key study information (purity, stability, characterization, and verification of the test material; strain, selection, diet, and housing of animals) was not provided.
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopentane
EC Number:
206-016-6
EC Name:
Cyclopentane
Cas Number:
287-92-3
Molecular formula:
C5H10
IUPAC Name:
cyclopentane
Details on test material:
- Name of test material (as cited in study report): cyclopentane
- Substance type: C5 aliphatics

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
not reported

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: none provided
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily and weighedat study initiation, on day 7, and on day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight
Statistics:
none

Results and discussion

Preliminary study:
not reported
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No animals died over the 14 days of observation.
Clinical signs:
Clinical signs observed over the first 24 hours after exposure included depression (sometimes slight), red stains on the nose and/or eyes, rough coat, soft feces, a hunched appearance, and urine stains. All animals appeared normal from day 2 until study termination.
Body weight:
Body weight was unaffected by treatment.
Gross pathology:
There were no gross abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 for cyclopentane is greater than 5000 mg/kg.
Executive summary:

In an acute oral toxicity study, cyclopentane was administered orally as a single 5000 mg/kg dose to male and female rats. Specifics of the treatment and vehicle were not provided. Animals were observed for 14 days, then a gross necropsy was performed. In the first 24 hours, rats exhibited depression or slight depression, red stains on the nose and/or eyes, rough coat, soft feces, hunched appearance, and urine stains. All animals were normal by day 2. No mortalities occurred during treatment or throughout the 14 -day observation period. There were no treatment-related changes in body weight or gross pathology. Based on the results, the oral LD50 of cyclopentane in male and female rats is greater than 5000 mg/kg.

This study received a Kilmisch score of 2 and is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study adhered to the principles outlines in OECD 423 guidelines.