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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it is in compliance with OECD principles of GLP and E.U. Council Decision on GLP.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-pentane
- Substance type: C5 aliphatic
- Physical state: liquid
- Analytical purity: not reported
- Lot/batch No.: MRD-96-575
- Other: Analyses for stability, identity, strength, purity, and composition were stated to have been performed by the testing laboratory, but specifics were not provided in the report.

Test animals

Species:
rat
Strain:
other: Crl:CDBR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc.
- Age at study initiation: 8 to 9 weeks old
- Weight at study initiation: Males: 206 to 221 grams; Females: 206 to 213 grams
- Fasting period before study: overnight
- Housing: individually housed in suspended stainless steel and wire mesh cages with absorbent paper below cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 to 76 °F
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 1996-08-07 To: 1996-08-21

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.33 ml/kg


Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed once or twice a day and body weights were obtained on the day prior to testing, the day of dosing, and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
None were performed.

Results and discussion

Preliminary study:
No preliminary study was performed and the limit dose was used.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One animal died within an hour of dosing due to intubation error. No deaths were associated with oral administration of the test material.
Clinical signs:
Clinical signs were observed in all of the remaining animals. The clinical signs including oral or nasal discharge, swollen abdomen, anogenital staining, and or soft or mucoidal stools were transient and limited to the day of exposure.
Body weight:
All animals gained weight during the 14 days post exposure.
Gross pathology:
There were no gross abnormalities observed during necropsy.

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 results indictae that n-pentane is not acutely toxic via the oral route of exposure.
Executive summary:

In an acute oral toxicity study, 5 rats per sex were given a single oral dose of undiluted n-pentane (pure) at a dose of 2000 mg/kg (3.33 ml/kg) and were observed for 14 days. There were no mortalities or consistent signs of systemic toxicity through the 14 days with no abnormalities noted at necropsy. The estimated LD50 for n-pentane is thus greater than 2000 mg/kg. This study is classified as reliable without restrictions because it is in compliance with OECD principles of GLP and E.U. Council Decision on GLP and follows the appropriate test guidelines