Methyl undec-10-enoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-05-17 till 1984-10-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: French Guideline NF T 03.021 from 1980

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl undec-10-enoate

EC Number:

203-910-8

EC Name:

Methyl undec-10-enoate

Cas Number:

111-81-9

Molecular formula:

C12H22O2

IUPAC Name:

methyl undec-10-enoate

Constituent 2

Reference substance name:

2023-910-8

IUPAC Name:

2023-910-8

Details on test material:

- Name of test material (as cited in study report): UNDECYLENATE DE METHYLE
- Substance type: organic
- Physical state: clear yellowish liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): no data
- Purity test date: 24.02.84
- Lot/batch No.: UNDECYLENATE DE METHYLE, Analyse 151
- Expiration date of the lot/batch: no data
- Stability under test conditions: not reported
- Storage condition of test material: not reported
- Other:

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France (76410, Saint Aubin les Elbeuf - France)
- Age: no data
- Weight at study initiation: 199g (males), 187g (females)
- Fasting period before study: no data
- Housing: 5 animals of same sex were housed in one polycarbonate cage with stainless top
- Diet (e.g. ad libitum): pelleted rat diet "Expanded SQC" (Special Diets Services Ltd, Witham, Essex, England)
- Water (e.g. ad libitum): potable water filtered through Millipore membrane, ad libitum
- Acclimation period: min. 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 50 % ± 20%
- Air changes (per hr): air was not recycled, air was filtered
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 1984-05-17 To: 1984-07-31

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: not applicable


MAXIMUM DOSE VOLUME APPLIED: 5.7 ml/kg


DOSAGE PREPARATION (if unusual):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

620, 1240, 1860, 2570 mg/kg body weight (pre-test 5000 mg/ kg bw)

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations frequently directly after test item application, and twice a day thereafter; body weight measurement just before test item application, and at days 4, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no statistics applied

Results and discussion

Preliminary study:

5000 mg/kg bw: animals are in state of coma one hour after test item application.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 563 mg/kg bw

95% CL:

>= 1 225 - <= 1 875

Mortality:

Number and date of deaths at each dose:
At 620 mg/kg: no death
At 1240 mg/kg: 2 dead animals on day 1
At 1860 mg/kg: 8 dead animals 3 hours after treatment
At 2570 mg/kg: 9 dead animals 3 hours after treatment

Clinical signs:

other: At 620 mg/kg: no symptom At 1240 mg/kg: hypokinesia on day 1, then no symptom At 1860 mg/kg: hypokinesia and sedation on day 1, pilo-erection from D1 to D6, then no symptom. At 2570 mg/kg: sedation on day 1, then no symptom. One male went into a coma

Gross pathology:

Due to absence of any macroscopally visible lesions, no further histopathologic investigations

Other findings:

- Organ weights: no abnormalities reported
- Histopathology: not investigated (see above)
- Potential target organs: not investigated
- Other observations:

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: other: Guidance to regulation (EC) No 1272/2008 on CLP of substances and mixtures.

Conclusions:

LD50 is assessed at 1563 mg/kg (95% CL 1225-1875 mg/kg). Symptoms start to appear within 15 min after treatment at the dose of 1248 mg/kg and above (hypokinesia, sedation and coma). Mortality appears 3 hours after treatment, until day 1. Acc. to UN-GHS, the test item UNDECYLENATE DE METHYLE is classified as acute toxic (oral) category 4.

Executive summary:

LD50 is assessed at 1563 mg/kg (95% CL 1225-1875 mg/kg). Symptoms start to appear within 15 min after treatment at the dose of 1248 mg/kg and above (hypokinesia, sedation and coma). Mortality appears 3 hours after treatment, until day 1. Acc. to UN-GHS, the test item UNDECYLENATE DE METHYLE is classified as acute toxic (oral) category 4.