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EC number: 203-311-1 | CAS number: 105-58-8
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- repeated dose toxicity: inhalation
- Remarks:
- other: subacute: 7 hours at 5 subsequent days for 4 weeks (see Trial 4)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No official guideline method but methodology and results well documented; no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
Materials and methods
- Principles of method if other than guideline:
- Inhalation studies were carried out according to methods from Farbenfabriken Bayer A.G., Werk Wuppertal-Elberfeld, Germany.
- GLP compliance:
- no
Test material
- Reference substance name:
- Diethyl carbonate
- EC Number:
- 203-311-1
- EC Name:
- Diethyl carbonate
- Cas Number:
- 105-58-8
- Molecular formula:
- C5H10O3
- IUPAC Name:
- diethyl carbonate
- Details on test material:
- - Name of test material (as cited in study report): "DIÄTHYLCARBONAT"
- Analytical purity:
German, original statement: "Für die Untersuchungen wurde eine chemisch reine Verbindung verwendet."
English, original statement translated: For the examinations a chemically pure compound was used.
Constituent 1
Test animals
- Species:
- other: mouse, rat, rabbit
- Details on test animals or test system and environmental conditions:
- Animals: Male NMRI-mice (weight 18-24 g), male and female Wistar-II-rats (weight 160-200 g), male and female Wistar-II-SPF-rats (weight 130-150 g) from the breeder Winkelmann, Kirchborchen, Germany; rabbits, male and female (weight 2,3 - 3,2 kg), of no specific breed
Administration / exposure
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Details on methodology see under 8 Analytical methods in this IUCLID dossier:
"DIÄTHYLCARBONAT - KONZENTRATIONSBESTIMMUNG IN DER INHALATIONSLUFT NACH VERDAMPFUNG" (original German title of the study)
Diethyl carbonate - determination of concentration in inhalation air after evaporation (German title translated into English)
Author: Dipl.-Chem. A. Eben, FARBENFABRIKEN BAYER AG, INSTITUT FÜR TOXIKOLOGIE
Report Nr.: 2182
Date: 31.07.1970
Summary air analyses:
Diethyl carbonate was determined in the air being inhaled according to a modified method of H. GARSCHAGEN (Z. analyt. Chem. 241, 32, 1868; Weinberg and Keller 14, 131, 1967). The air being inhaled was conveyed through a vessel cooled down to -30 °C (absorption vessel). Determination by gas chromatography.
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- > 18.995 mg/L air (analytical)
- Basis for effect level:
- other: 18.995 mg/l was the average measured concentration. The term "NOAEC" was not used in study report. The NOAEC was spotted out by the author of the IUCLID dossier.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Explanation term "toxicological result" in the tables (.../.../...):
1. Number = Number of died animals
2. Number = Number of animals with symptoms
3. Number = Number of animals used for the test
-----------
1. Toxicity of aerosols
Results Trial 1:
| Male rats | ||||
| theoretical substance concentration in air (mg/l) | analytically determined substance concentration in air (mg/l) | daily exposure time (h) | number of subsequent exposure days number of subsequent exposure days | toxicological result after 14 d |
| 2.0 | 0.452 | 4 | 1 | 0/0/20 |
| 5.0 | 1.83 | 7 | 1 | 0/0/20 |
| 2.0 | 0.499 | 4 | 5 | 0/0/10 |
| 5.0 | 1.593 | 7 | 5 | 0/0/10 |
| Female rats | ||||
| theoretical substance concentration in air (mg/l) | analytically determined substance concentration in air (mg/l) | daily exposure time (h) | number of subsequent exposure days | toxicological result after 14 d |
| 5.0 | 1.268 | 4 | 1 | 0/0/20 |
| 2.0 | 0.499 | 7 | 5 | 0/0/10 |
| 5.0 | 1.593 | 4 | 5 | 0/0/10 |
LC50, male rats, 1 day * 7 h exposure, > 1.83 mg/l
LC50, male rats, 5 days * 7 h exposure, > 1.593 mg/l
LC50, female rats, 1 day * 7 h exposure, > 1.268 mg/l
LC50, female rats, 5 day * 7 h exposure, > 1.593 mg/l
In Trial 1 no signs of toxicity or irritation were found in the rats.
Results Trial 2:
| theoretical substance concentration in air (mg/l) | analytically determined substance concentration in air (mg/l) | type of animal | toxicological result |
| 1.0 | 0.235 | rabbit | 0/0/2 |
| 1.0 | 0.235 | rat | 0/0/10 |
| 1.0 | 0.235 | mouse | 0/0/20 |
| 5.0 | 2.179 | rabbit | 0/0/2 |
| 5.0 | 2.179 | rat | 0/0/10 |
| 5.0 | 2.179 | mouse | 0/0/20 |
In Trial 2 no signs of toxicity or signs of irritation for the mucosas of eyes and noses were found.
----------
2. Toxicity of vapours
Results Trial 3:
No indication of toxicity or irritation was found in rats exposed to diethyl carbonate. At the section of the animals the inner organs were unchanged.
| Male rats | |||
| analytically determined substance concentration in air (mg/l) | daily exposure time (h) | number of subsequent exposure days | toxicological result after 14 d |
| 17.75 | 4 | 1 | 0/0/20 |
| 19.50 | 7 | 1 | 0/0/20 |
| 20.971 | 7 | 5 | 0/0/10 |
| Female rats | |||
| analytically determined substance concentration in air (mg/l) | daily exposure time (h) | number of subsequent exposure days | toxicological result after 14 d |
| 18.30 | 4 | 1 | 0/0/20 |
| 19.50 | 7 | 1 | 0/0/20 |
| 20.971 | 7 | 5 | 0/0/10 |
Results Trial 4:
Rats exposed to the test substance did not show a different behavior to the rats of the control group.
The weight gain of organs was also not significantly different in the rats treated with the test substance.
The hematological examinations did also give no evidence of a difference between rats exposed or not exposed to the substance. The measured values were within the range of normal physiological values.
The average activities and measured concentrations of values indicating the function of liver and kidney were also found to be the same in the test group and the control group. The values were all within the normal physiological range.
At the autopsy of the animals the organ weights of the treated and untreated group were not significantly different (average absolute organ weights in mg and average relative organ weights in mg/100 g of body weight; comparison of males and females separately; comparison of the different types of organs separately). Examined organs were: thyroid, heart, lung, liver, spleen, both kidneys, adrenal glands, testes, ovaries.
Table 1
| Male rats | |||
| analytically determined substance concentration in air (mg/l) | daily exposure time (h) | number of subsequent exposure days | toxicological result after 14 d |
| 17.75 | 4 | 1 | 0/0/20 |
| 19.50 | 7 | 1 | 0/0/20 |
| 20.971 | 7 | 5 | 0/0/10 |
| Female rats | |||
| analytically determined substance concentration in air (mg/l) | daily exposure time (h) | number of subsequent exposure days | toxicological result after 14 d |
| 18.30 | 4 | 1 | 0/0/20 |
| 19.50 | 7 | 1 | 0/0/20 |
| 20.971 | 7 | 5 | 0/0/10 |
Table 2
| Male rats | ||||
| concentration of the substance in air (mg/l) | body weight at the beginning of the test period (g) | body weight after 4 weeks (g) | weight difference after 4 weeks - beginning (g) | p (= probability) |
| control | 143 | 245 | 102 | - |
| 18.995 | 143 | 224 | 81 | > 0.05 |
| Female rats | ||||
| concentration of the substance in air (mg/l) | body weight at the beginning of the test period (g) | body weight after 4 weeks (g) | weight difference after 4 weeks - beginning (g) | p (= probability) |
| control | 139 | 190 | 51 | - |
| 18.995 | 139 | 182 | 43 | > 0.05 |
Table 3
| Male rats | |||||||
| concentration of the substance (mg/l) | hemoglobin % (weight/weight) | Erythrocytes 10^6 | HbE (average hemoglobin content of cells) | Leukocytes 10^3 | Thrombocytes 10^3 | Haematocrit % | MCV (average cell volume of erythrocytes) (µm³) |
| control | 14.6 | 7.65 | 19 | 5.4 | 918 | 50 | 66 |
| 18.995 | 14.1 | 7.15 | 20 | 3.9 | 744 | 46 | 64 |
| Female rats | |||||||
| concentration of the substance (mg/l) | hemoglobin % (weight/weight) | Erythrocytes 10^6 | HbE (average hemoglobin content of cells) | Leukocytes 10^3 | Thrombocytes 10^3 | Haematocrit % | MCV (average cell volume of erythrocytes) (µm³) |
| control | 12.5 | 6.23 | 20 | 5.1 | 782 | 41 | 65 |
| 18.995 | 12.4 | 6.41 | 19 | 5.4 | 698 | 41 | 65 |
Table 4
| Male rats | |||||
| concentration of the substance (mg/l) | liver function: GOT (mU/ml) | liver function: GPT (mU/ml) | liver function: SDH (mU/ml) | kidney function: urea (mg/100 ml) | kidney function: creatinine (mg/100 ml) |
| control | 27.3 | 13.4 | 0.5 | 40.3 | 1.85 |
| 18.995 | 26.5 | 13.2 | 0.7 | 37.5 | 1.50 |
| Female rats | |||||
| concentration of the substance (mg/l) | liver function: GOT (mU/ml) | liver function: GPT (mU/ml) | liver function: SDH (mU/ml) | kidney function: urea (mg/100 ml) | kidney function: creatinine (mg/100 ml) |
| control | 28.1 | 11.2 | 1.2 | 45.8 | 1.40 |
| 18.995 | 28.4 | 11.7 | 1.1 | 39.7 | 1.32 |
Table 5
| Male rats | |||||||||
| concentration of the substance (mg/l) | body weight (g) | thyroid average absolute weight (mg) | heart average absolute weight (mg) | lung average absolute weight (mg) | liver average absolute weight (mg) | spleen average absolute weight (mg) | both kidneys average absolute weight (mg) | adrenal glands average absolute weight (mg) | testes average absolute weight (mg) |
| control | 245 | 11.8 | 650 | 1281 | 10084 | 577 | 1541 | 42.0 | 2835 |
| 18.995 | 224 | 11.8 | 628 | 1122 | 9240 | 500 | 1450 | 44.6 | 2743 |
| concentration of the substance (mg/l) | / | thyroid average relative weight (mg/100 g bw) | heart average relative weight (mg/100 g bw) | lung average relative weight (mg/100 g bw) | liver average relative weight (mg/100 g bw) | spleen average relative weight (mg/100 g bw) | both kidneys average relative weight (mg/100 g bw) | adrenal glands average relative weight (mg/100 g bw) | testes average relative weight (mg/100 g bw) |
| control | / | 4.8 | 266 | 530 | 4114 | 237 | 631 | 17.1 | 1162 |
| 18.995 | / | 5.2 | 281 | 502 | 4109 | 223 | 647 | 20.0 | 1226 |
| Female rats | |||||||||
| concentration of the substance (mg/l) | body weight (g) | thyroid average absolute weight (mg) | heart average absolute weight (mg) | lung average absolute weight (mg) | liver average absolute weight (mg) | spleen average absolute weight (mg) | both kidneys average absolute weight (mg) | adrenal glands average absolute weight (mg) | ovaries average absolute weight (mg) |
| control | 190 | 9.9 | 527 | 892 | 7219 | 506 | 1110 | 60.8 | 78.1 |
| 18.995 | 183 | 10.2 | 526 | 879 | 7024 | 495 | 1093 | 62.6 | 70.8 |
| concentration of the substance (mg/l) | / | thyroid average relative weight (mg/100 g bw) | heart average relative weight (mg/100 g bw) | lung average relative weight (mg/100 g bw) | liver average relative weight (mg/100 g bw) | spleen average relative weight (mg/100 g bw) | both kidneys average relative weight (mg/100 g bw) | adrenal glands average relative weight (mg/100 g bw) | ovaries average relative weight (mg/100 g bw) |
| control | / | 5.2 | 278 | 469 | 3793 | 266 | 583 | 32.0 | 41.0 |
| 18.995 | / | 5.5 | 287 | 478 | 3824 | 270 | 596 | 27.9 | 38.7 |
Applicant's summary and conclusion
- Conclusions:
- In respect of the 28d study it was concluded in the study report:
In male and female groups of rats, exposed to diethyl carbonate for 7 h on 5 d for 4 weeks at a concentration of 18.995 mg/l air, no significant differences were found compared to the control group in respect of behaviour, body weight gain, blood status, functionality of liver and kidneys and organ weights.
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