1,4-Dioxaspiro[4.5]decane, 8-[4-(4-methylphenyl)-3-cyclohexen-1-yl]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 22, 2003 - July 23, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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:

December 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:

Official Journal of the European communities No. L 248, September 30, 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

603-101-3

EC Number:

603-101-3

Cas Number:

125962-78-9

Molecular formula:

C21 H28 O2

IUPAC Name:

603-101-3

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HsdCpb:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 6 to 11 weeks
- Weight at study initiation: 165 – 185 g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: Separately in type III Makrolon cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 49 – 68%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
IN-LIFE DATES: From day 1 to day 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

Methocel® K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: well tolerated and established standard vehicle

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (m) / 3 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, gross pathology

Statistics:

Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

All rats survived the observation period.

Clinical signs:

No signs of intoxication occurred after treatment.

Body weight:

Body weight development of the treated rats was normal.

Gross pathology:

At necropsy, no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential up to the limit dose of 2000 mg/kg bw. Therefore, the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats.

Executive summary:

The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight according to OECD test guideline 423 and under GLP conditions. Directly before administration, the test material was prepared with aqueous Methocel K4M Premium solution as a vehicle. No signs of intoxication occurred after treatment. Body weight development of the treated rats was normal. All the rats survived the observation period. At necropsy, no organ alterations were seen. Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.