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Toxicological information

Acute Toxicity: oral

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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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted Dec 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted in Aug 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Freie und Hansestadt Hamburg, Behörde für Soziales, Familie und Verbraucherschutz, Hamburg, Germany
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octa-1,7-diene
EC Number:
223-054-9
EC Name:
Octa-1,7-diene
Cas Number:
3710-30-3
Molecular formula:
C8H14
IUPAC Name:
octa-1,7-diene

Test animals

Species:
rat
Strain:
other: Crl: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 172 - 183 g
- Fasting period before study: yes, 16 hours before treatment
- Housing: 3 animals/cage in Makrolon cages type III plus
- Diet: ssniff R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24 Feb 2012 To: 21 Mar 2012

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.78 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 per step)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: before and immediately, 5, 15, 30, 60 min as well as 3, 6, 24 hours after administration, at least once a day thereafter
- Frequency of weighing: before administration and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor acitivity as well as behaviour pattern; clinical signs (tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma), body weight; histopathology was only carried out in case of macroscopical findings

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: According to OECD Guideline 423, Annex 2d, a cut-off value of 5000 mg/kg bw was derived based on a limit test with 2000 mg/kg bw, since no mortality occurred in any step.
Mortality:
No mortality occurred.
Clinical signs:
other: The following clinical signs were observed: slightly reduced motility (30 min - 3 h, 6/6 animals), slight ataxia (30 min - 3 h, 6/6 animals), slightly increased muscle tone (30 min - 3 h, 6/6 animals), salivation (15 min - 3 h, 6/6 animals) and pilo-erect
Gross pathology:
No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
No mortality was observed in 2 groups of 3 female rats at the limit dose of 2000 mg/kg bw using the acute-toxic-class method. Thus, the LD50 cut-off value was 5000 mg/kg bw according to OECD Guideline 423.