Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was well performed according to an established protocol with no major deficiencies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
yes
Remarks:
Humidity was outside protocol range but did not affect study outcome.
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Humidity was outside protocol range but did not affect study outcome.
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes
EC Number:
810-258-3
Molecular formula:
not applicable; UVCB
IUPAC Name:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes
Constituent 2
Reference substance name:
Alcohols, C2-33, manuf. of, by-products from overheads
IUPAC Name:
Alcohols, C2-33, manuf. of, by-products from overheads
Test material form:
liquid
Specific details on test material used for the study:
Label Identification: HF-1000 Solvent Sample No 1319-50
Date & Quantity Received: 19 Jun 08; 929.2 g (Gr.Wt.)
Physical Description: Yellow oily liquid
Storage: Room temperature
Density: 0.8158 g/mL

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Species & Strain: Albino rat; Sprague-Dawley
Justification of Species: The rat is a representative rodent species preferred by various regulatory agencies for use in an acute oral study.
Source: Texas Animal Specialties, Humble, TX
Date Born/Date Received: 2 Jun 08 / 24 Jul 08
Quarantine Period: 5 days
Quantity & Sex: 5 females (nulliparous and non-pregnant)
Animal/Group Identification: Ear punch / Cage cards
Cage Type: Suspended, wire bottom, stainless steel
Housing: 1 per cage
Environmental Controls Set to Maintain:
• Temperature 22°± 3° C
• 12-hour light/dark cycle
• Relative Humidity 30-70%
• 10-12 air changes/hour
Actual Temp/Rel. Humidity: 19-24°C / 53-89% [Protocol deviation: humidity was outside protocol range but did not affect study outcome.]
Food: PMI Feeds Inc.TM Formulab #5008; available ad /ibitum except for approximately 16 hours before dosing
Water: Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered as received and was not diluted.
Doses:
An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 2.45 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing. The dose level was 2000 mg/kg.
No. of animals per sex per dose:
Five females dosed at 2000 mg/kg
Control animals:
no
Details on study design:
The objective of this study was to assess the acute oral toxicity potential of the test substance when administered by gavage to rats in accordance with US EPA OPPTS 870.1100, which is intended to meet testing requirements of FIFRA 7 USC 136, et seq, and TSCA 15 USC 2601; and OECD 425. This study was conducted for Sasol North America Inc., according to the approved protocol and STILLMEADOW, Inc. SOPs. There were no deviations from the protocol that affected the quality or outcome of the study. All procedures used in this study are in compliance with Animal Welfare Act Regulations. The protocol, raw data, this report and a sample of test substance are archived at STILLMEADOW, Inc. The study was initiated on 18 Jul 08, the pre-dose experimental portion began on 28 Jul 08.

Results and discussion

Preliminary study:
There was no mortality during the study. The estimated acute oral LD50, as indicated by the data, was determined to be greater than 2000 mg/kg.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study.
Clinical signs:
All animals appeared normal for the duration of the study.
Body weight:
Body weight gain was unaffected by the administration of the test substance.
Gross pathology:
The gross necropsy conducted at termination of the study revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test substance was evaluated for its acute oral toxicity potential when administered to albino rats. The acute oral LD50 is estimated to be greater than 2000 mg/kg in females.
Executive summary:

The test substance was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose at a level of 2000 mg/kg. The study was terminated following the stopping rules of this procedure. No mortality occurred during the study. There were no clinical signs of toxicity during the study. There was no effect on body weight gain. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.