Reaction mass of 4-methyl-1-oxaspiro[5.5]undec-3-ene and 4-methyl-1-oxaspiro[5.5]undec-4-ene and 4-methylidene-1-oxaspiro[5.5]undecane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 October, 1983 - 24 October, 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The information is used for read across to Oxaspirane-819.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

4-(1-methoxy-1-methylethyl)-1-methylcyclohexene

EC Number:

238-620-0

EC Name:

4-(1-methoxy-1-methylethyl)-1-methylcyclohexene

Cas Number:

14576-08-0

Molecular formula:

C11-H20-O

IUPAC Name:

4-(1-Methoxy-1-methylethyl)-1-methylcyclohexene

Test material form:

liquid

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 Breeding Laboratories, Wilmington, Massachusetts, USA
- Weight at study initiation: 180 – 280 (after fasting)
- Fasting period before study: 18 hours
- Housing: individually, in stainless steel wire mesh cages,
- Diet: Wayne Lab Blox, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

only for 3200 mg/kg bw dosing

Doses:

3200, 4000, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed immediately and at 1, 4 and 24 hours after dosing and twice daily for 14 days. Body weights were recorded on the 14th day.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

In a dose-range finding study, 4 fasted animals, 2 per sex, were administered the test article at 500, 1600 and 5000 mg/kg bw, orally by gavage. Signs observed were abnormal gait, abnormal stance, decreased body tone, piloerection, decreased activity, lacrimation, semiprostration, salivation, poor grooming and prostration. None of the animals died at the 500 or 1600 mg/kg bw dose levels. 3 of 4 animals died at the 5000 mg/kg bw dose level.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- 1 out of 5 males and 2 out of 5 females died exposed to 3200 mg/kg bw
- 1 out of 5 males and 2 out of 5 females died exposed to 4000 mg/kg bw
- 1 out of 5 males and 1 out of 5 females died exposed to 5000 mg/kg bw

Clinical signs:

Signs observed included decreased activity, abnormal stance, prostration, hypersensitivity, exophthalmos, tremors, semiprostration and dyspnea. One rat was observed with paralysis of both front pays due to self-traumatization.

Gross pathology:

- Necropsy of the animals that died revealed discoloration of the intestines and bladder. Hemorrhages in the stomach, cecum and bladder were observed. Necrotic livers and congested, edematous lungs were also observed.
- Atrophy of the testes was observed upon necropsy of the sacrificed male animals. No test article related lesions were observed in the females that were sacrificed.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

according toEU CLP (EC No. 1272/2008 and its amendments)

Conclusions:

The acute oral toxicity test showed an LD50 of >5000 mg/kg bw in study according to OECD TG 401.

Executive summary:

In an acute oral toxicity test five Sprague-Dawley rats per sex per dose were exposed to the test substance via oral gavage to 3200, 4000, and 5000 mg/kg bw in a study according to OECDTG 401. Signs observed included: decreases activity, salivation, lacrimation, poor grooming, piloerection, decreased body tone, abnormal gait, abnormal stance, prostration, hypersensitivity, exophthalmos, tremors, semiprostration and dyspnea. One rat was observed with paralysis of both front paws due to self-traumatization. Three of ten animals died at the 3200 and 4000 mg/kg bw dose levels and two out of ten died at 5000 mg/kg bw. Necropsy of the animals that died revealed discoloration of the intestines and bladder. Hemorrhages in the stomach, cecum and bladder were observed. Necrotic livers and congested, edematous lungs were also observed. Atrophy of the testes was observed upon necropsy of the sacrificed male animals. No test article related lesions were observed in the females that were sacrificed. The acute oral LD50 for substance in both males, females and combined was determined to be >5000 mg/kg bw.