3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 1984-09-25 and 1984-10-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD test guideline 401 (1984)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

EC Number:

251-090-5

EC Name:

3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

Cas Number:

32539-83-6

Molecular formula:

C15H26O1

IUPAC Name:

2H,3H,4H,5H,6H,7H,8H,9H,10H,11H,12H,13H,14H-cyclododeca[b]pyran

Details on test material:

- Name of test material (as cited in study report): 3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran
- Substance type: active
- Physical state: clear liquid
- Storage condition of test material: ambient temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Tuck & Sons Limited, Battlesbridge, Essex
- Age at study initiation: ca 4-6 weeks
- Weight at study initiation: 129-234g (males) 129-159 (females)
- Fasting period before study: overnight prior to start of dosing
- Housing: Animals were housed in groups of five by sex in polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No.1, ad libitum
- Water (e.g. ad libitum): main tap water, ad libitum
- Acclimation period: minimum five days prior to the start of the experiment


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+-2°C, recorded daily
- Humidity (%): 60-68% RH, not controlled but recorded daily on a wet and dry bulb hygrometer
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours


IN-LIFE DATES: From: 1984-09-06 To: 1984-09-30

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: not used

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw


DOSAGE PREPARATION (if unusual): test material was used undiluted, as supplied.


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Range finding study performed on groups of two males and two females of the same rats of the main study; Animals were observed daily for five days, or until all evidence of toxicity had subsided, whichever was the longer.

Doses:

1 dose: 2000 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 1/2, 1, 2, 3, 4 and 5 hours following dosing; after at least daily; bodyweight recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: post-mortem examinations

Statistics:

not required

Results and discussion

Preliminary study:

There were no mortalities during the range-funding study. Therefore, a dose level of 2000 mg/kg was selected for the Main Study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortalities observed

Clinical signs:

other: Signs of reaction to treatment observed shortly after dosing in all rats consisted of pilo-erection, an abnormal body carriage (hunched posture), lethargy and a decreased respiratory rate. Ptosis and increased salivation were also seen in one rat.

Gross pathology:

no abnormalities

Any other information on results incl. tables

Clinical signs

Recovery of all rats, as judged by external appearance and behaviour, was apparently complete by Day 2.

Please, see attached tables.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of DDP to the rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was based on the recommendations of the OECD Guidelines for Testing of Chemicals No, 401 "Acute Oral

Toxicity" (1984). The results of the study are believed to be of value in predicting the likely toxicity of the test material to man.

The test system was chosen because the rat has been shown to be a suitable model for this type of study. A range finding was performed on groups of two animals (two males, two females). The dose level for the main study was determined at 2000 mg/kg bodyweight. Groups of five animals (five males and five females) were trated with the dose level to determine the toxicity of the test material. Animals were checked daily. The clinical signs observed were pilo-erection, an abnormal body carriage (hunched posture), lethargy and a decreased respiratory rate. Ptosis and increased salivation were also seen in one rat. Recovery of all rats was complete by day two. No mortalities were found during the 14 days period. The bodyweight gain was unaffected. After the necropsy, no abnormalities were seen. Under the conditions of the procedure, the test material present a LD50 greater than 2000 mg/kg bodyweight in the rat.