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Toxicological information

Acute Toxicity: oral

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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:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
other: Spartan
Sex:
male/female
Details on test animals 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:
No data
Body weight:
All surviving rats exhibited normal body weight gain over the study period.
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.