2-tetradecyloxirane, reaction products with boric acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-12-10 to 1980-12-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Section 772.112-21 CFR 40.

Deviations:

no

Principles of method if other than guideline:

Five groups of five male albino rats were administered with single dose of 1,000, 2,000, 4,000, 8,000 and 16,000 mg/kg bw and observed for 14 days period during which time the rats were observed for signs of toxicity and mortalities.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

1

Reference substance name:

2-tetradecyloxirane, reaction products with boric acid

EC Number:

701-392-2

IUPAC Name:

2-tetradecyloxirane, reaction products with boric acid

Test material form:

not specified

Details on test material:

- Date of receipt: 1980-11-19

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: No data available.
Age at study initiation: No data available.
Weight at study initiation: average weight between 200~300 g.
Fasting period before study: Feed was withheld overnight prior to dosing.
Housing: No data available.
Diet: ad libitum
Water: ad libitum
Acclimation period: No data available.

ENVIRONMENTAL CONDITIONS
Temperature (°C): No data available.
Humidity (%):No data available.
Air changes: No data available.
Photoperiod: No data available.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

1,000, 2,000, 4,000, 8,000 and 16,000 mg/kg bw

No. of animals per sex per dose:

5/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available.
- Necropsy of survivors performed: Gross necropsies were performed.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Based on:

test mat.

Mortality:

One death occurred after 5-6 h in the 16,000 mg/kg bw dose group and no mortality in the remaining groups.

Clinical signs:

other: - There were no unusual behavioral signs noted at 1000, 2000 and 4000 mg/kg bw. - After 2 h, the animals appeared lethargic and ruffled; they appeared normal within 24 h. - After 1-2 h, the animals were depressed, ruffled and dirty. One death occurred a

Gross pathology:

No gross abnormalities were noted in all animals.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article when administered to male Sherman-Wistar rats, had an acute oral LD50 of higher than 16,000 mg/kg bw.

Executive summary:

Test Guidance

According to US EPA Section 772.112-21 CFR 40.

Method and material

A single dose of the undiluted test material was administered intragastrically to 5 groups of fasted male albino rats (Sherman-Wistar strain) at each treatment level (1,000, 2,000, 4,000, 8,000, and 16,000 mg/kg bw). The animals were observed for signs of toxicity or behavioral changes during the 14 day observation period. Individual weights were recorded on the day of dosing and at termination.

Results

There were no unusual behavioral signs noted at 1000, 2000 and 4000 mg/kg bw. After 2 h, the animals appeared lethargic and ruffled; they appeared normal within 24 h. After 1-2 h, the animals were depressed, ruffled and dirty. One death occurred after 5-6 h. Within 24 h the condition of the surviving animals had improved. They appeared essentially normal after 48 h. One death occurred after 5-6 h in the 16,000 mg/kg bw dose group and no mortality in the remaining groups. Gross autopsies were performed and nothing remarkable was revealed. The oral LD50 value of test material in rats has been determined to be higher than 16,000mg/kg bw.

Conclusion

In accordance with EU CLP (Regulation (EC) No. 1272/2008), classification is not required.