Registration Dossier
Registration Dossier
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EC number: 202-710-8 | CAS number: 98-88-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2.c: Comparable to a guideline study with acceptable restrictions. Well described. Only data on survivors necropsy, gross pathology and clinical examinations of dosed animals are missing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- clinical exminations, necropsy and gross pathology not examined
- GLP compliance:
- not specified
- Remarks:
- Probably no as no existing GLP standards at the time
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Benzoyl chloride
- EC Number:
- 202-710-8
- EC Name:
- Benzoyl chloride
- Cas Number:
- 98-88-4
- Molecular formula:
- C7H5ClO
- IUPAC Name:
- benzoyl chloride
- Details on test material:
- - Name of test material (as cited in study report): benzoyl chloride
- Physical state: clear liquid
- Lot/batch No.: D11-I40-626
No further details
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Spartan
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 201 to 266 grams
- Fasting period before study: 24 hours prior the experiment
- Housing: temeprature and humidity controlled quarters
- Diet (e.g. ad libitum): unspecified but ad libitum
- Water (e.g. ad libitum): ad libitum
No further information
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
No further details - Doses:
- 500, 1250, 1984, 3150, 5000 and for one extra group of males 7940 mg/Kg
- No. of animals per sex per dose:
- 5 per sex and per dose. Five extra males were tested at 7940 mg/Kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 hours and 24 hours after gavage and then subsequent daily observations
- Necropsy of survivors performed: no
- Other examinations performed: no data
No further details - Statistics:
- LD 50 were established according to Thompson W.R., (1947), Bact. Rev., 11, 115-145.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 619 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 008 - <= 4 353
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 518 - <= 2 380
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 618 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 129 - <= 3 219
- Mortality:
- cf table in other information on results
- Clinical signs:
- other: No data
- Gross pathology:
- No data
Any other information on results incl. tables
Acute oral toxicity (LD 50) in male Albino rats
| Dose mg/kg |
Number of rats dead | Total number of dead rats/dosed rats |
LD 50 and confidence limits (mg/Kg) | |||||||
| Hours 0-4 | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7-14 | |||
| 500 | 0/5 | |||||||||
| 1250 | 0/5 | |||||||||
| 1984 | 0/5 | |||||||||
| 3150 | 1/5 | 1/5 | 3619 | |||||||
| 5000 | 1/5 | 4/5 | 5/5 | (3008-4353) | ||||||
| 7940 | 5/5 | 5/5 | ||||||||
Acute oral toxicity (LD 50) in female Albino rats
| Dose mg/kg |
Number of rats dead | Total number of dead rats/dosed rats |
LD 50 and confidence limits (mg/Kg) | |||||||
| Hours 0-4 | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7-14 | |||
| 500 | 0/5 | |||||||||
| 1250 | 0/5 | 1900 | ||||||||
| 1984 | 1/5 | 2/5 | 3/5 | ( 1518-2380) | ||||||
| 3150 | 4/5 | 1/5 | 5/5 | |||||||
| 5000 | 3/5 | 2/5 | 5/5 | |||||||
Acute oral toxicity (LD 50) in male and female Albino rats
| Dose mg/kg |
Number of rats dead | Total number of dead rats/dosed rats |
LD 50 and confidence limits (mg/Kg) | |||||||
| Hours 0-4 | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7-14 | |||
| 500 | 0/10 | |||||||||
| 1250 | 0/10 | 2618 | ||||||||
| 1984 | 1/10 | 2/10 | 3/10 | ( 2129-3219) | ||||||
| 3150 | 4/10 | 2/10 | 6/10 | |||||||
| 5000 | 4/10 | 6/10 | 10/10 | |||||||
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In the test conditions, the authors tested the acute oral toxicity of benzoyl chloride and found LD 50s in male and female Spartan rats respectively of 3619 and 1900 mg/Kg.
Hence according the CLP regulation EC n° 1272/2008 and the DSD directive n° 67/548 EEC, benzoyl chloride should be classified as harmfull if swallowed. - Executive summary:
The authors of this study report tested the acute oral toxicity of benzoyl chloride (CAS n° 98 -88 -4) on male and female Spartan rats weighing initially between 201 and 266 grams. They followed a procedure equivalent to the OECD guideline n°401 with minor deviations. Five groups of five rats per sex were dosed at 500, 1250, 1984, 3150, 5000 and for one extra group of males at 7490 mg/Kg of benzoyl chloride. The test substance was administered orally by gavage in corn oil. Only mortality and weight were monitored Mortality was observed daily and weighing was conducted at the beginning and the end. LD 50 were then established.
Hence, in the test conditions, all surviving rats exhibited normal body weight gain over the study period. Besides, the LD 50 are reported to be at 3619 (3008 -4353) mg/Kg for males, 1900 (1518 -2380) mg/Kg for females and 2618 ( 2129 -3213) mg/Kg for the combined sexes.
Altogether according the CLP regulation EC n° 1272/2008 and the DSD directive n° 67/548 EEC, benzoyl chloride should be classified as harmfull if swallowed, or an acute tox category 4, H 302.
This study report is well described and based on a good methodology similar to the OECD guideline 401. Minor deviations are observed. Indeed data are lacking on the clinical observations, the survivors necropsy and the gross pathology of dosed rats. Hence, this study report could be considered as reliable with restrictions, a Klimisch 2.c study, comparable to a guideline study with acceptable restrictions.
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