Octa-1,7-diene

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted Dec 2001

Deviations:

no

Test guideline 2

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

Test guideline 3

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

Test material information

Constituent 1

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.