[[(2-ethylhexyl)oxy]methyl]oxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from July 19, 1983 to August 2, 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[[(2-ethylhexyl)oxy]methyl]oxirane

EC Number:

219-553-6

EC Name:

[[(2-ethylhexyl)oxy]methyl]oxirane

Cas Number:

2461-15-6

Molecular formula:

C11H22O2

IUPAC Name:

2-{[(2-ethylhexyl)oxy]methyl}oxirane

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rationale: The rat has been selected for this test as being a standard species for the determination of an acute oral LD50.
Species and Strain: Rat, Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial Body Weight Range: 166 - 208 g
Initial Age: 7 - 8 weeks
Individual Identification: By colour code using picric acid
Husbandry: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin). The animal room was air conditioned: temperature 22 ±3 ° C, relative humidity was 55 ±15%, 12 hours light/day, approximately 15 air changes/h.
Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

Pre-treatment:
The animals were allocated to the different dose groups by random selection. Prior to dosing, the animals were fasted overnight.
Administration: oral, by gastric intubation (gavage)
Observation Period: 14 days or until all symptoms have disappeared, whichever lasts longer
Volume (ml/kg body weight) applied: 10

Doses:

5000, 1000 mg/kg bw.

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

Dose Levels : 5000/ 1000 mg/kg bw.
Numher of Animals Per Dose Level : 5 males and 5 females
Total Number of animals: 20
Administration of the Test Article: One single dose, per os
Observations and Records:
Mortality: Daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and Symptoms: daily
Body weight: On days 1, 7, 14 and at death
Necropsy: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Company standard:
high acute toxicity... LD50 <50 mg/kg
medium acute toxicity... LD50 50 - 500 mg/kg
slight acute toxicity... LD50 500 - 5000 mg/kg
practically no acute toxicity....LD50 >5000 mg/kg

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95% confidence limit were computed by the logit method.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One of females was dead at the level of 5000 mg/kg bw in the first day of post-exposure period.

Clinical signs:

other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute test. In addition, the high dose animals showed sedation, tremor and ventral body position.

Gross pathology:

Besides two spotted lungs no gross lesions were found at necropsy.

Any other information on results incl. tables

TABLE 2 BODY WEIGHTS AND STANDARD DEVIATIONS (GMS)

	males			female
dose mg/kg	day 1	day 7	day 14	day 1	day 7	day 14
1000	202/6.7	268/15.4	317/13.3	180/9.0	211/9.4	236/15.2
5000	198/6.8	223/11.5	265/23.9	179/5.5	196/11.6	221/11.9

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU-CLP

Conclusions:

Based on the current condition, TK 10529 has practically no acute toxicity when administered orally to the albino rat.
LD50(oral, rat): >5000mg/kg bw in rats of both sexes

Executive summary:

Upon an acute oral administration and a 14 day post-treatment observation period, the LD50 determined for test substance is greater than 5000 mg/kg bw (no 95% confidence limits calculated, as not possible). Twenty animals were administered orally by gavage at concentrations of 1’000 an 5’000 mg/kg bw. Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute test. In addition, the high dose animals showed sedation, tremor and ventral body position. However, lack of any clear dose-relation or adverse effects on body weight, gross pathological appearance indicated an absence of toxicity. Thus, it can be concluded that test substance exerts no toxic influence in rats of either sex at levels up to 5’000 mg/kg bw.