Acetic acid, anhydride, reaction products with 1,5,10-trimethyl-1,5,9-cyclododecatriene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 September 1981 - 23 September 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-330-9

EC Name:

-

Cas Number:

144020-22-4

Molecular formula:

C17H26O

IUPAC Name:

1-[(1E,5Z,9Z)-2,5,10-trimethylcyclododeca-1,5,9-trien-1-yl]ethan-1-one; 1-[(1R)-2,5,10-trimethylcyclododeca-2,5,9-trien-1-yl]ethan-1-one; 1-[(1R)-4,9-dimethyl-12-methylidenecyclododeca-4,8-dien-1-yl]ethan-1-one; 1-[(1S)-2,5,10-trimethylcyclododeca-2,5,9-trien-1-yl]ethan-1-one; 1-[(1S)-4,9-dimethyl-12-methylidenecyclododeca-4,8-dien-1-yl]ethan-1-one

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms Altamont, New York
- Weight at study initiation: 180 - 280 gm (after fasting)
- Fasting period before study: 18 hours
- Housing: Individually in stainless steel wire mesh cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 C +/- 3 C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

DOSAGE PREPARATION (if unusual): Dose level 5000 mg/kg: dosed as received

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose (10 animals per dose group)

Control animals:

no

Details on study design:

- Duration of observation period following administration: fourteen days
- Frequency of observations and weighing: Immediately, one, four and twenty-four hours after dosing, and daily for 14 days thereafter
- Necropsy of survivors performed: yes, gross necropsy
- Other examinations performed: pharmatoxic, central nervous system (CNS) effects, clinical signs, body weight, mortality, gross necropsy

Statistics:

Not applied

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No rats died. The major signs observed included, diarrhoea, lachrymation, body drop, catatonia, hunched back, gnawing at the fore paws, ataxia, head tremors and yellow discolouration of the fur around ventral and

Gross pathology:

Effects on organs: Terminal necropsy revealed no lesions in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

other: Not harmful according to EU CLP (1272/2008 and its amendments)

Conclusions:

The substance has an LD50 of > 5000 mg/kg bw in an OECD TG equivalent 401 test.

Executive summary:

The acute oral toxicity in female and male rats was studied in accordance to a guideline similar to OECD TG 401 and GLP principles. The substance was administered orally to one group of ten rats (5 females and 5 males) at 5000 mg/kg. Signs observed included diarrhea, lacrimation, body drop, catatonia, hunched back, gnawing at forepaws, ataxia, hypersensitivity to touch, head tremors, exophthalmus, abnormal gait, piloerection, red exudate around oral cavity, and a yellow discoloration of the fur (ventral and genital area). None of the ten rats died at 5000 mg/kg. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >5000 mg/kg. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.