Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed according to the EPA 660/3-75-009 guideline which is similar to the EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test). No data on the GLP procedure was reported but validity criteria were partially fulfilled. Besides, the fish toxicity was well investigated and sufficiently described. Thus we consider this study to be reliable with restrictions, a Klimisch 2e study since it is well documented, meets generally accepted scientific principles and is acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity of 12 industrial chemicals to freshwater and saltwater organisms
Author:
Curtis M.W., Copeland T.L. and Ward C.H.
Year:
1979
Bibliographic source:
Water research, 13: 137-141

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA 660/3-75-009 (Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
yes
Remarks:
pH not measured every 24h, no measurement of test substance concentration at 48h, acclimation of 4 days, only cold freshwater species was investigated
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): benzoyl chloride
- Stability under test conditions: Benzoyl chloride reacted with the dilution water to produce benzoic acid and HCl.

No more data available

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes

Test organisms

Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: fathead minnow
- Source: EPA Newtown Fish Toxicology Station, Cincinnati, Ohio
- Length at study initiation (length definition, mean, range and SD): 3.2 to 4.2 cm standard length
- Feeding during test
- Food type:
- Amount:
- Frequency:
- Other:
- Fish were held in circular fiberglass tanks with a 6 vol day-1 flow through of carbon filtered tap water
- Feeding: a twice daily ration of Tetra SM (Tetra-Werke, W. Germany)
- 16h light-8h dark diurnal cycle
- Initial prophylactic treatment for external parasites consisting of 5 mg/L potassium permanganate administered on three consecutive days. Then hygienic conditions were maintained by sterilizing all fish care equipment with a 200 mg/L calcium hypochlorite solution
- Fish were observed for a minimum of 14 days (at least 10 days after any disease treatment) before being acclimated for testing

ACCLIMATION
- Acclimation period: 4 days
first two days: acclimation to the test dilution water quality and temperature (i.e. solution withdrawal and renewal twice daily accomplished water quality transition and temperature was reduced from 25 to 22°C with the aid of a temperature bath-circulator)
last two days: fish held at 22°C in 100% dilution water
- Type and amount of food: no food was given during acclimation

No more data

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96
Remarks on exposure duration:
h

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
42.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CI: 35.4 - 57.4
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
34.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CI: 28.5 - 45.3
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
34.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CI: 28.5 - 45.3

Any other information on results incl. tables

- Mortality in control and solvent control: less than 10% in all cases

- Linear regression analysis to compare the measured concentrations to the nominal: no satisfactory correlation between the two series

- Benzoyl chloride reacted with the dilution water to produce benzoic acid and HCl, causing a pH decrease to 5.2. However, a far more serious effect was the biochemical oxygen demand of the benzoic acid.

Applicant's summary and conclusion

Validity criteria fulfilled:
no
Remarks:
partially fulfilled (see overall remarks)
Conclusions:
The authors tested the toxicity of benzoyl chloride to the fathead minnow (Pimephales promelas) according to the EPA 660/3-75-009 guideline. Under these test conditions the LC50(96h) for the fathead minnow exposed to benzoyl chloride was 34.7 mg/L (95% CI: 28.5-45.3 mg/L). Thus, based on the classification categories given in the CLP regulation (EC) No 1272/2008 the test substance cannot be classified as hazardous to the fathead minnow as its LC50 at 96h is above 1 mg/L (based on nominal concentration).
Executive summary:

The authors tested the toxicity of benzoyl chloride (CAS n° 98 -88 -4) to the fathead minnow (Pimephales promelas) according to the EPA 660/3-75-009 (Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians) guideline which is similar to the EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test) guideline.

Two replicates of five fish were exposed to a dilution serie of benzoyl chloride during 96h and deaths were recorded. Further analytical measurements were performed (i.e. measured test substance concentrations, pH, dissolved oxygen and temperature) but not all results were reported for these measurements.

Under these test conditions the LC50(96h) for the fathead minnow exposed to benzoyl chloride was 34.7 mg/L (95% CI: 28.5-45.3 mg/L). Thus, based on the classification categories given in the CLP regulation (EC) No 1272/2008 the test substance cannot be classified as hazardous to the fathead minnow as its LC50 at 96h is above 1 mg/L (based on nominal concentration).

No data on the GLP procedure was reported and validity criteria were partially fulfilled. The validity criteria concerning mortality in the controls, which should not exceed 10% during the 96h testing period, was fulfilled. The other criteria could only be considered partially fulfilled since all results on measurements needed to evaluate the validity criteria were not reported. Considering the overall quality of the study and the level of details, thus this study should be considered as reliable with restrictions, a Klimisch 2.e study.