Reaction mass of 5,9-Undecadienal-2,6,10-trimethyl-, (5E)- and 5,9-Undecadienal-2,6,10-trimethyl-, (5Z)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no information on test substance purity, limited documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no information on test substance purity, limited documentation

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 5,9-Undecadienal-2,6,10-trimethyl-, (5E)- and 5,9-Undecadienal-2,6,10-trimethyl-, (5Z)-

EC Number:

942-376-7

Molecular formula:

C14H24O

IUPAC Name:

Reaction mass of 5,9-Undecadienal-2,6,10-trimethyl-, (5E)- and 5,9-Undecadienal-2,6,10-trimethyl-, (5Z)-

Test animals

Species:

rat

Strain:

Wistar

Remarks:

SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 155 - 195 g
- Fasting period before study: 16 h prior to dosing
- Housing: in macrolon plastic cages, wood chips bedding
- Diet: commercial pellets (Ssniff/Intermast Standard, Soest, Germany)
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

20 mL/kg bw (corresponding to 17400 mg/kg bw based on a density of 0.87 g/cm³)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortalities at intervals on the day of dosing and at least once daily thereafter for an entire period of 14 days. Body weight was recorded on day of administration and on Day 14 before sacrifice.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Remarks on result:

other: LD50 > 17400 mg/kg bw based on a density of 0.87 g/cm³

Mortality:

No mortality occurred during the study period.

Clinical signs:

No toxicity symptoms were observed.

Body weight:

No effect on body weight gain was noted.

Gross pathology:

No pathological-anatomical changes were found in the cranial-, thoracic- and abdominal cavity during the section.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study a LD50 value > 20 mL/kg bw (corresponding to > 17400 mg/kg bw based on a density of 0.87 g/cm³) in male and female rats was found.

Executive summary:

The acute oral toxicity of the test substance was assessed in a study similar to OECD Guideline 401 (1979).10 male and 10 female rats were administered a single dose of 20 mL/kg bw via gavage. No mortality occurred within 14 days. Thus, a LD50 > 20 mL/kg bw (corresponding to > 17400 mg/kg bw based on a density of 0.87 g/cm³) was derived.