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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Qualifier:
according to
Guideline:
other: Method A-11
Deviations:
no
Principles of method if other than guideline:
No data
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
None
Analytical monitoring:
no
Details on sampling:
Not available
Vehicle:
not specified
Details on test solutions:
No data
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
Test type:
not specified
Water media type:
not specified
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No data
Hardness:
No data
Test temperature:
25 deg C
pH:
No data
Dissolved oxygen:
No data
Salinity:
No data
Nominal and measured concentrations:
No data
Details on test conditions:
No data
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
other: TL0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
other: TL50
Effect conc.:
140 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
other: TL100
Effect conc.:
200 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Details on results:
No data
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
No data

None

Validity criteria fulfilled:
not specified
Conclusions:
TL0 (48 h) : 100 mg/l
TL50 (48 h) : 140 mg/l
TL100 (48 h) : 200 mg/l
Executive summary:

TL0 (48 h) : 100 mg/l

TL50 (48 h) : 140 mg/l

TL100 (48 h) : 200 mg/l

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Qualifier:
according to
Guideline:
other: Method A-11
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
None
Analytical monitoring:
no
Details on sampling:
Not available
Vehicle:
not specified
Details on test solutions:
No data
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
Test type:
not specified
Water media type:
not specified
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No data
Hardness:
No data
Test temperature:
25 deg C
pH:
No data
Dissolved oxygen:
No data
Salinity:
No data
Nominal and measured concentrations:
No data
Details on test conditions:
No data
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
other: TL0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
other: TL50
Effect conc.:
177 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
other: TL100
Effect conc.:
< 300 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
other: TL0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
other: TL50
Effect conc.:
152 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
other: TL100
Effect conc.:
< 300 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Details on results:
No data
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
No data

None

Validity criteria fulfilled:
not specified
Conclusions:
TL0 (48 h) : 100 mg/l
TL50 (48 h) : 177 mg/l
TL100 (48 h) : <300 mg/l
TL0 (96 h) : 100 mg/l
TL50 (96 h) : 152 mg/l
TL100 (96 h) : <300 mg/l
Executive summary:

TL0 (48 h) : 100 mg/l

TL50 (48 h) : 177 mg/l

TL100 (48 h) : <300 mg/l

TL0 (96 h) : 100 mg/l

TL50 (96 h) : 152 mg/l

TL100 (96 h) : <300 mg/l

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Qualifier:
according to
Guideline:
other: Method A-11
Deviations:
no
Principles of method if other than guideline:
No data
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
None
Analytical monitoring:
no
Details on sampling:
Not available
Vehicle:
not specified
Details on test solutions:
No data
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
Test type:
not specified
Water media type:
not specified
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No data
Hardness:
No data
Test temperature:
No data
pH:
No data
Dissolved oxygen:
No data
Salinity:
No data
Nominal and measured concentrations:
No data
Details on test conditions:
No data
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
623 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
1 000 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
454 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1 000 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Details on results:
No data
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
No data

None

Validity criteria fulfilled:
not specified
Conclusions:
LC0 (48 h) : 100 mg/l
LC50 (48 h) : 623 mg/l
LC100 (48 h) : 1000 mg/l
LC0 (96 h) : 100 mg/l
LC50 (96 h) : 454 mg/l
LC100 (96 h) : 1000 mg/l
Executive summary:

LC0 (48 h) : 100 mg/l

LC50 (48 h) : 623 mg/l

LC100 (48 h) : 1000 mg/l

LC0 (96 h) : 100 mg/l

LC50 (96 h) : 454 mg/l

LC100 (96 h) : 1000 mg/l

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Qualifier:
according to
Guideline:
other: Method A-11
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
None
Analytical monitoring:
no
Details on sampling:
Not available
Vehicle:
not specified
Details on test solutions:
No data
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
Test type:
not specified
Water media type:
not specified
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No data
Hardness:
No data
Test temperature:
25 deg C
pH:
No data
Dissolved oxygen:
No data
Salinity:
No data
Nominal and measured concentrations:
No data
Details on test conditions:
No data
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
181.5 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
300 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
143.12 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
300 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Details on results:
No data
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
No data

None

Validity criteria fulfilled:
not specified
Conclusions:
LC0 (48 h) : 100 mg/l
LC50 (48 h) : 181.5 mg/l
LC100 (48 h) : 300 mg/l
LC0 (96 h) : 100 mg/l
LC50 (96 h) : 143.12 mg/l
LC100 (96 h) : 300 mg/l
Executive summary:

LC0 (48 h) : 100 mg/l

LC50 (48 h) : 181.5 mg/l

LC100 (48 h) : 300 mg/l

LC0 (96 h) : 100 mg/l

LC50 (96 h) : 143.12 mg/l

LC100 (96 h) : 300 mg/l

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Blue 049, where the sulphonate group is bound at the meta-position of the aminobenzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Blue 049.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.

2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Blue 49 meta/para (CAS# 72214-18-7 / EC# 276-481-8)
Target: Reactive Blue 49 meta (CAS# 72927-99-2 / EC# 277-040-2)

3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.2 Melting point / freezing point
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Conclusions:
Based on a weight-of-evidence approach for the source substance, it was clear that the 96h-LC50 value was >100 mg/L ( range 140 - 454 mg/L). The structurally related target substance will show the same behaviour, and the 96h-LC50 will be as well >100 mg/L.

Description of key information

96h-LC50 > 100 mg/L in zebrafish and trout

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

The weight-of-evidence approach used for the source substance describes four internal Huntsman studies. Only basic data is given.

In none of the four studies mortality was observed in zebrafish or trout at (or below) the concentration of 100 mg/L.

In the 1974 study, all trout died at 200 mg/L (time of exposure unknown), while the TL50 value was stated to be 140 mg/L.

In the 1982 study, all zebrafish died after 24h of exposure to 300 mg/L, while the 96h-TL50 value was stated to be 152 mg/L.

In the 1983 study, all zebrafish died after 24h of exposure to 1000 mg/L, while the 96h-LC50 value was stated to be 454 mg/L.

In the 1984 study, all zebrafish died after 24h of exposure to 300 mg/L and after 4h of exposure to 1000 mg/L, while the 96h-LC50 value was stated to be 143 mg/L.

The structurally related target substance will show the same behaviour and therefore it can be anticipated that the 96h-LC50 will be >100 mg/L as well.