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Administrative data

Description of key information

In the key study for acute oral toxicity study conducted with the target substance tert-butyl glycidyl ether the oral LD50 was determined to be 2000 mg/kg bw. Based on this result classification as Acute Tox 4, H302 is warranted. That classification for Acute Oral Toxicity is warranted is further supported by an acute oral toxicity study conducted with the structural analogue n-butyl glycidyl ether. The oral LD50 obtained from an acute oral toxicity study in mice treated with this read-across partner was 1530 mg/kg bw.

In an acute inhalation toxicity study five female Sprague Dawley rats were whole-body exposed for 7 hours to a vapour concentration of 17.72 mg/L of the target substance. No adverse signs of toxicity were observed. Based on the results the LD0 can be considered to be 17.72 mg/L and in accordance with the CLP regulation 1272/2008 no classification for acute inhalation toxicity is warranted.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1972-01-12 to 1972-07-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
other:
Limit test:
no
Specific details on test material used for the study:
- Name: 1-tert-Butoxy-2,3-epoxypropane
- Purity: 99 %
- Appearance: Colourless liquid
- Solubility at room temperature: <1% for water, >25 % for acetone and benzene
Species:
rat
Strain:
not specified
Sex:
male
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
126, 252, 500, 1000 and 2000 mg/kg bw
No. of animals per sex per dose:
2 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were weighed and observed at intervals over a two week post feeding or until any weight loss was regained and the animals appeared healthy.
- Necropsy of survivors performed: Yes, the following tissues were examined: trachea, lung, heart, liver, kidneys, adrenal, spllen, pancreas, stomach, small intestine, large intestine and reproductive organs.
Statistics:
Not specified
Preliminary study:
n.a.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
One out of two rats died at 2000 mg/kg bw. No further mortality observed.
Clinical signs:
not specified
Body weight:
No decrease in body weight was observed.
Gross pathology:
From all animals, one animal per dose group were gross pathological assessed. No gross pathological findings were seen in the animals from the three low dose groups (126, 252 and 500 mg/kg bw). In animal 11 from the dose group 1000 mg/kg bw the following findings were reported: (external) There was a very slight accumulation of darkened material near the external naries. In all probability this was increased porphyrin sections. (internal) The mucosal surface of the stomach was slightly edematous. There was no large pocket of edematous fluid as was decribed for the high dose rat. In all probability the diffuse edema was related to treatment. In animmal 02 from the high dose group the following findings were reported: (external) There was a slight accumulation of dark staining material external to the naries. In all probability this was increased porphyrin sections. (internal) The mucousal surface of the stomach contained some edematous type of fluid. This principally was a large accumulation located between the mucosal and underlying musculature. This area was also congested. In all probability this was related to treatment. It could not be determined that this lesion was associated with possibly some trauma associated with the intubation process. No other visble lesions were noted.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In an acute oral toxicity study conducted equivalent to OECD TG 401, the target substance (99% purity) was orally administered to 2 male rats per dose group comprising of concentrations 126, 252, 500, 1000 and 2000 mg/kg bw. The animals were observed for 14 days. Observations were made at frequent intervals to check the body weights. The body weights and the pathological observations had no treatment related effects and no mortality was observed up to 1000 mg/kg bw. One out of two rats treated with 2000 mg/kg bw died. Hence, according to this study, it can be concluded that the LD50 of the substance is 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study conducted equivalent to OECD TG 401, the target substance (99% purity) was orally administered to 2 male rats per dose group comprising of concentrations 126, 252, 500, 1000 and 2000 mg/kg bw. The animals were observed for 14 days. Observations were made at frequent intervals to check the body weights. The body weights and the pathological observations had no treatment related effects and no mortality was observed up to 1000 mg/kg bw. One out of two rats treated with 2000 mg/kg bw died. Hence, according to this study, it can be concluded that the LD50 of the substance is 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Comparable to guideline study

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973-02-22
Reliability:
2 (reliable with restrictions)
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To evaluate the the acute inhalation toxicity for t-Butylglycidyl ether monomer
- Short description of test conditions: Five female Sprague Dawley albino rats were placed in a 19 liter round glass exposure chamber made from a battery jar. Air was metered through the test material maintained at room temperature or at 140 °C into the chamber at the rate of approximately 1 liter per minute, for seven hours. The nominal concentration was calculated from the ratio of the weight of material vaporized to the total volume of air bubbled through the material during the entire exposure period. The rats were weighed and examined prior to use. During, and for two weeks following exposure, the rats were examined frequently for changes in demeanor and untoward physical effects , including changes in body weight. A gross pathological examination of one of the test animals was performed 24 hours post-exposure. The remaining test animals and untreated controls were sacrificed two weeks post-exposure and subjected to a pathological examination.
- Parameters analysed / observed: Body weight, gross pathology
GLP compliance:
not specified
Test type:
traditional method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Round glass exposure chamber
- Exposure chamber volume: 19 L
- Method of holding animals in test chamber: Animmals were placed in the jar
- Source and rate of air: Air was metered through the test material at the rate of 1 L/ min
- Temperature: room temperature or 140 °C

TEST ATMOSPHERE
- Brief description of analytical method used: The nominal concentration was calculated from the ratio of the weight of material vaporized to the total volume of air bubbled through the material during the entire exposure period
Duration of exposure:
7 h
Concentrations:
- 17.72 mg/L (3333 ppm), generated at room temperature
- 8 6.02 mg /L (16180 ppm), generated at 140 °C
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
Five female Sprague Dawley albino rats were placed in 19 liter round glass exposure chamber made from a battery jar. Air was metered through the test material maintained at room temperature or at 140 °C into the chamber at the rats of approximately 1 liter per minute, for seven hours. The nominal concentration was calculated from the ratio of the weight of material vaporized to the total volume of air bubbled through the material during he entire exposure period. The rats were weighed and examined prior to use. During and for two weeks following exposure, the rats were examined frequently fro changes in demeanor and untoward physical effects, including changes in body weight. A gross pathological examinantion of one of the test animals was performed 24 hours post exposure. The remaining test animals and untreated controls were sacrificed two weeks post-exposure and subjected to a pathological examination.
Statistics:
Mean body weight and standard deviation
Key result
Sex:
female
Dose descriptor:
LC0
Effect level:
17.72 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Key result
Sex:
female
Dose descriptor:
LC50
Effect level:
< 86.02 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Mortality:
No treatment related mortality was observed at a concentration of 17.72 mg/L. At a test concentration of 86.02 mg/L, four out of five rats died after 5.5 to 6.5 hours of exposure.
Clinical signs:
No treatment related signs were observed at concentration of 17.72 mg/L. At a test concentration of 86.02 mg/L, all animals exhibited eye irritation and subsequent corneal opacity as well as gasping and irregular breathing during exposure.
Body weight:
No significant change in body weight was observed.
Gross pathology:
No treatment related signs were observed at concentration of 17.72 mg/L. At a test concentration of 86.02 mg/L, gross pathology of the animals revealed pulmonary edema and effusion.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute inhalation toxicity study, five female Sprague Dawley rats were exposed to 17.72 mg/L and 86.02 mg/L vapour concentrations of the test material for 7 hours. At the test concentration 17.72 mg/L, no treatment related effects were observed. However, at a test concentration of 86.02 mg/L, four out of five rats died. Hence, it can be concluded that the test material was well tolerated up to 17.72 mg/L (LC0) without showing any mortality and classification for acute inhalation toxicity is not warranted.
Executive summary:

In an acute inhalation toxicity study, five female Sprague Dawley rats were exposed whole-body to vapour concentrations of 17.72 mg/L and 86.02 mg/L of t-Butylglycidyl ether monomer for 7 hours. At a test item concentration of 17.72 mg/L, no treatment related effects were observed. However, at a test item concentration of 86.02 mg/L, four out of five rats died. Hence, it can be concluded that the test material was well tolerated up to 17.72 mg/L (LC0) without showing any mortality and classification for acute inhalation toxicity is not warranted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Comparable guideline study

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key study for acute oral toxicity study conducted with the target substance tert-butyl glycidyl ether the oral LD50 was determined to be 2000 mg/kg bw. Based on this result classification as Acute Tox 4, H302 is warranted. That classification for Acute Oral Toxicity is warranted is further supported by an acute oral toxicity study conducted with the structural analogue n-butyl glycidyl ether. The oral LD50 obtained from an acute oral toxicity study in mice treated with this read-across partner was 1530 mg/kg bw.

In an acute inhalation toxicity study five female Sprague Dawley rats were whole-body exposed for 7 hours to a vapour concentration of 17.72 mg/L of the target substance. No adverse signs of toxicity were observed. Based on the results the LD0 can be considered to be 17.72 mg/L and in accordance with the CLP regulation 1272/2008 no classification for acute inhalation toxicity is warranted.

Justification for classification or non-classification

Based on the available results, classification for acute oral toxicity is warranted (Acute Tox 4, H302). Based on the results from an acute inhalation toxicity study no classification is warranted for acute inhalation toxicity.