Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study was carried out according to test guidline and under GLP-conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4'-chloro-3-hydroxy-2-naphthanilide
EC Number:
202-189-7
EC Name:
4'-chloro-3-hydroxy-2-naphthanilide
Cas Number:
92-78-4
Molecular formula:
C17H12ClNO2
IUPAC Name:
N-(4-chlorophenyl)-3-hydroxynaphthalene-2-carboxamide

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)

Study design

Test type:
static
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
2.1 - 2.5 mmol Ca2+ + Mg2+/L
Test temperature:
22.0 - 22.1°C
pH:
7.6 -7.8
Dissolved oxygen:
6.8 - 8.7 mg/L
Nominal and measured concentrations:
Nominal: 0/10000 mg/L
Measured: Due to the very low solubility of the test substance in water (0.098 mg/L), the values decreased from 1.49 mg/L at study start to a concentration below the detection limit (0.05 mg/L) due to setting down of fine dispersed test substance
Details on test conditions:
use of reconstituted water, composition acc. to ISO/DIS 7346/1
Reference substance (positive control):
yes

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: lethality value based on loading rates (nominal conc.)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: lethality value based on loading rates (nominal conc.)
Duration:
96 h
Dose descriptor:
LC100
Remarks on result:
other: not determined

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
67/548/EEC: Acute aquatic toxicity: no classification
1272/2008/EC: Acute aquatic toxicity: no classification
Executive summary:

No lethality was observed up to the solubility limit of Naphtol AS-E. The 10000 mg/L group exhibited reversible symptoms.