Registration Dossier
Registration Dossier
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EC number: 200-666-4 | CAS number: 67-72-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: test performed prior to guideline availability but with procedures similar to standard methods and with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- other: Published toxicological report
- Title:
- Toxicological Profile for Hexachloroethane
- Author:
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Year:
- 1 997
- Bibliographic source:
- Not reported
- Reference Type:
- publication
- Title:
- The toxicity of hexachloroethane in laboratory animals.
- Author:
- Weeks MH, Angerhofer RA, Bishop R, Thomasino J, Pope CR.
- Year:
- 1 979
- Bibliographic source:
- Am Ind Hyg Assoc J. 1979 Mar;40(3):187-99. doi: 10.1080/15298667991429499. PMID: 495459.
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: determine the acute oral toxicity of the test material by dosing rats with a single administration and monitoring mortality over a 14-day observation period.
- Short description of test conditions: the test compound was dissolved in corn oil (50% w/v) or methylcellulose (5% w/v). Solutions were administered by stomach tube to male and female rats. The oral LD50 were calculated after a 14-day observation period.
- Parameters analysed / observed: mortality - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hexachloroethane
- EC Number:
- 200-666-4
- EC Name:
- Hexachloroethane
- Cas Number:
- 67-72-1
- Molecular formula:
- C2Cl6
- IUPAC Name:
- hexachloroethane
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Hummel Chemical Company, specifications MIL-H-235B, national stock number 6810-00-N00-001
- Purity: technical grade, 99.8%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: housed in suspended wire cages
- Diet: ad libitum, commercial chow (Zeigler)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 24 ± 2°C
- Humidity: 45-55%
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Administered as 50% solution in corn oil or 5% solution in methylcellulose
- Doses:
- 2510, 3160, 3980, 5010, 6310, 7940, 10 000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- Not specified
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 7 080 mg/kg bw
- Based on:
- not specified
- 95% CL:
- 6 240 - 8 040
- Remarks on result:
- other: as 5% solution in methylcellulose
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 7 690 mg/kg bw
- Based on:
- not specified
- 95% CL:
- 6 380 - 9 250
- Remarks on result:
- other: as 5% solution in methylcellulose
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 460 mg/kg bw
- Based on:
- not specified
- 95% CL:
- 3 900 - 5 110
- Remarks on result:
- other: as 50% solution in corn oil
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 160 mg/kg bw
- Based on:
- not specified
- 95% CL:
- 4 250 - 6 270
- Remarks on result:
- other: as 50% solution in corn oil
- Mortality:
- See the table below for detailed results for the test material in corn oil.
- Clinical signs:
- other: Red exudate appeared around eyes at all dosages and persisted throughout 14-day observation period. Tremors, ataxia, gasping appeared in dosages of 5010 mg/kg and higher and persisted for 3 days.
- Gross pathology:
- One dead rat showed degeneration of the kidney cortex.
No gross lesions except those attributable to euthanasia were observed in survivors.
Any other information on results incl. tables
Dosage | Conc. % in corn oil | Onset of signs (S), mortality (M) | Cumulative mortality | Mean body weight (g) | ||||||||||||||
Hours | Days | Init | Fin |
| Days | |||||||||||||
0-4 | 4-12 | 12-24 | 2 | 3 | 4 | 5 | 6 | 7 | 8-14 |
|
|
|
| 3 | 7 | 14 | ||
2510 | 50 |
| S |
|
|
|
|
|
|
|
| 0/6 | 212 ± 4 | 272 ±16 |
| 228 ±9 | 253 ±12 | 272 ±16 |
3160 |
| S |
| M = 1 | M = 1 |
|
|
|
|
| 2/6 | 210 ±9 | 272 ±10 |
| 221 ±12 | 249 ±10 | 272 ±10 | |
3980 |
| S |
|
|
|
|
|
|
|
| 0/6 | 205 ±6 | 251 ±30 |
| 190 ±41 | 221 ±29 | 251 ±30 | |
5010 |
| S | M = 2 |
|
|
|
|
|
|
| 2/6 | 210 ±7 | 254 ±18 |
| 207 ±11 | 227 ±13 | 254 ±18 | |
6310 |
| S | M = 3 | M = 1 |
|
|
|
| M = 1 |
| 5/6 | 210 ±4 | 250 |
| 187 | 217 | 250 | |
7940 |
| S | M = 1 | M = 3 | M = 1 |
|
|
|
|
| 5/6 | 240 ±4 | 215 |
| 164 | 190 | 215 | |
10000 |
| S | M = 1 | M = 2 | M = 2 | M = 1 |
|
|
|
| 6/6 | 205 ±6 | - |
| - | - | - | |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions applied, the test material is of low acute toxicity by oral route, with a LD50 (female rats) of 4460 mg/kg bw.
- Executive summary:
The acute toxicity of hexachloroethane was assessed by performing an acute oral toxicity study in Sprague-Dawley rats. There was no information regarding a standardised method or GLP.
The test material dissolved in either corn oil (50% w/v) or methylcellulose (5% w/v) was administered by stomach tube to male and female rats. The dose administered ranged from 2510 to 10 000 mg/kg bw. The oral LD50 were calculated after a 14-day observation period.
Oral LD50 were of 5160 mg/kg bw in males and 4460 mg/kg bw in females administered with the test material in corn oil. With hexachloroethane dissolved in methylcellulose, LD50 were of 7690 and 7080 mg/kg bw in males and females, respectively. Red exudate appeared around eyes at all dosages and persisted throughout 14-day observation period. Tremors, ataxia, gasping appeared in dosages of 5010 mg/kg and higher and persisted for 3 days. One dead rat showed degeneration of the kidney cortex. No gross lesions except those attributable to euthanasia were observed in survivors.
Under the test conditions applied, the test material is of low acute toxicity by oral route and is not classified according to the classification criteria of regulation (EC) 1272/2008 (CLP).
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