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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:
key study
Study period:
From 23 November 1992 to 27 November 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Pently salicylate is being used as a read across for hexyl salicylate.
Analytical monitoring:
yes
Details on sampling:
GC analysis of the test concentrations 0.8, 1.1, 1.6, 2.3, 3.3, 4.7 mg.L and a control at test start (23-11-1992) and after 24-hours of exposure within the semi-static procedure of the test. Additional analysis on 24 November 1992 in the freshly prepared media and after 24 hours of exposure (25-11-1992).
Vehicle:
no
Details on test solutions:
To produce the test concentrations, the test substance was weighed into water and treated for 60 seconds at 800 rpm. with an ultra turrax.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Species: Zebra Fish (Brachydanio rerio Hamilton Buchanan)
- Origin: West-Aquarium (Bad Lauterberg)
- Date of Birth: 18 May 1992
- Date supplied: 11 August 1992
- Body Length: 2.5 - 3.5 cm
- Keeping Conditions: SOP 4.001
- Mortality while kept: < 2 %
- medical Pretreatmetn: None
- Keeping Water: Synthetic freshwater in accordance with ISO
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Remarks on exposure duration:
with renewal of water every 24 hours
Hardness:
14.9 dH
Test temperature:
21.3 - 22.3 °C
pH:
7.4 - 8.2
Dissolved oxygen:
88.0 - 108.2 %; 7.5 - 9.3 mg/L
Salinity:
Not applicable
Nominal and measured concentrations:
0.8, 1.1, 1.6, 2.3, 3.3 and 4.7 mg/L.
Details on test conditions:
- Operating Conditions: Semi-static tes in accordance with SOp 4.002. Daily renewal of the test medium.
- Photoperiod: 12 hour light/12 hours darkness
- Test Procedure: - test vessels (300 x 135 x 200 mm)
- 5 L test medium
- ventilated
- semi-static
- Method of Administration: direct weighing
- Solubiliser or other auxilaries: ultra turrax.
- Water for dilution: synthetic freshwater un accordance with ISO
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.95 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1.9 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
other: LC50 based on LC0 / LC100
Effect conc.:
1.34 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Concentration of the test substance: 2.3 mg/L
- after 48 hours: 10 animals sluggish swimming action

Concentration of the test substance: 3.3 mg/L
- after 48 hours: 10 sluggish animals swimming action
- after 72 hours: 2 animals sluggish swimming action
- after 96 hours: 1 animal sluggish swimming action

Concentration of the test substance: 4.7 mg/L
- after 2 hours: 10 animals sluggish swimming action
- after 24 hours: 7 animals sluggish swimming action
1 animal motionless, uncontrolled swimming action when touched.
Results with reference substance (positive control):
Not applicable

Analytical results

Nominal conc. (mg/L)

Measured conc. (mg/L)

Measured conc. (mg/L)

New

Old

New

Old

Control

<0.1

<0.1

<0.1

<0.1

0.8

0.7

0.3

0.7

0.3

1.1

1.0

0.3

1.0

0.3

1.6

1.6

0.6

1.5

0.6

2.3

2.1

0.6

2.3

0.8

3.3

3.0

1.0

3.3

0.9

4.7

4.9

1.6

4.5

2.2

Mortality during the study

Nominal conc. (mg/L)

Cumulative mortality (%)

24 h

48 h

72 h

96 h

Control

0

0

0

0

0.8

0

0

0

0

1.1

0

0

0

0

1.6

0

0

0

0

2.3

0

0

0

0

3.3

0

0

0

0

4.7

50

100

100

100

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of amyl salicylate to Danio rerio was determined. Based on mean measured concentrations the 96 hour LC0 was determined to be 0.95 mg/L, the corresponding 96 hour LC100 was determiend to be 1.90 mg/L. The 96 hour LC50 of 1.34 mg/L was determined by dividing the 96 hour LC0 and LC100 values.

Due to the similar structural, physical and chemical properties of amyl salicylate, it was considered appropriate for the purposes of read-across to Hexyl Salicylate.
Executive summary:

A read-across report was provided as support for this data point.

The acute toxicity of amyl salicylate to Danio rerio was determiend. The study was carried out according to EU Method C1- Acute Toxicity for Fish. In this study Danio rerio were exposed to the amyl salicylate over a test period of 96 hours in semi-static conditions with test medi renewal every 24 hours. Nominal concentrations were used: 0.8, 1.1, 1.6, 2.3, 3.3 and 4.7 mg/L. Two sets of analysis were performed on new and 24 aged media. The results of the study were based on the arithmetic measured concentrations.

The 96 hour LC0 was determined to be 0.95 mg/L, the corresponding 96 hour LC100 was determiend to be 1.90 mg/L. The 96 hour LC50 of 1.34 mg/L was determined by dividing the 96 hour LC0 and LC100 values.

Due to the similar structural, physical and chemical properties of amyl salicylate, it was considered appropriatefor the purposes of read-across to Hexyl Salicylate.

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
It is considered appropriate to address the data requirements for hexyl salicylate by read-across to the available studies on structurally similar substances.
Hexyl salicylate and amyl salicylate are both composed of the salicylate group and a carbon chain of similar length (six carbons long in hexyl salicylate and five carbons long amyl salicylate). The substances are therefore sufficiently similar in terms of chemical structure to support a read-across approach.
Reason / purpose:
read-across source
Specific details on test material used for the study:
Pently salicylate is being used as a read across for hexyl salicylate.
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.95 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1.9 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
other: LC50 based on LC0 / LC100
Effect conc.:
1.34 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Concentration of the test substance: 2.3 mg/L
- after 48 hours: 10 animals sluggish swimming action
Concentration of the test substance: 3.3 mg/L
- after 48 hours: 10 sluggish animals swimming action
- after 72 hours: 2 animals sluggish swimming action
- after 96 hours: 1 animal sluggish swimming action

Concentration of the test substance: 4.7 mg/L
- after 2 hours: 10 animals sluggish swimming action
- after 24 hours: 7 animals sluggish swimming action
1 animal motionless, uncontrolled swimming action when touched.
Results with reference substance (positive control):
Not applicable

Analytical results

Nominal conc. (mg/L)

Measured conc. (mg/L)

Measured conc. (mg/L)

New

Old

New

Old

Control

<0.1

<0.1

<0.1

<0.1

0.8

0.7

0.3

0.7

0.3

1.1

1.0

0.3

1.0

0.3

1.6

1.6

0.6

1.5

0.6

2.3

2.1

0.6

2.3

0.8

3.3

3.0

1.0

3.3

0.9

4.7

4.9

1.6

4.5

2.2

Mortality during the study

Nominal conc. (mg/L)

Cumulative mortality (%)

24 h

48 h

72 h

96 h

Control

0

0

0

0

0.8

0

0

0

0

1.1

0

0

0

0

1.6

0

0

0

0

2.3

0

0

0

0

3.3

0

0

0

0

4.7

50

100

100

100

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the target substance hexyl salicylate to D. rerio was estimated to be 96 h LC50 = 1.34 mg/L, based on read-across from a study testing amyl salicylate.
Executive summary:

The acute toxicity of the target substance hexyl salicylate toD. reriois estimated to be a 96 h LC50= 1.34 mg/L, based on read-across from a study testing amyl salicylate.

Due to the similar structural, physical and chemical properties of amyl salicylate, it was considered appropriate for the purposes of read-across to hexyl salicylate.

As explained in the justification for type of information, hexyl salicylate and amyl salicylate share similar structural, physical and chemical properties. Both substances are composed of the salicylate group and a carbon chain of similar length (six carbons long in hexyl salicylate and five carbons long amyl salicylate). The substances are therefore sufficiently similar in terms of chemical structure to support a read-across approach.

Description of key information

Data from two fish acute toxicity studies are presented:
Danio rerio were exposed to the hexyl salicylate at nominal test concentrations of: 0, 1, 10 and 100 mg/L. This study was carried out to OECD Guideline 203, the study appears to have been conducted as a range-finding test with a concentration spacing factor or 10 and only three concentrations tested. Hexyl salicylate was tested over the limit of solubility, without specific preparation and with no analytical verification. At the end of the 96 hour exposure period there was 20% mortality in the nominal 100 mg/L test treatment, therefore the 96 hour LC50 was observed to >100 mg/L (Licata-Messana, 2000).
A read-across report was also provided as support for this data point. The acute toxicity of amyl salicylate to Danio rerio was determined. Based on mean measured concentrations the 96 hour LC0 was determined to be 0.95 mg/L, the corresponding 96 hour LC100 was determined to be 1.90 mg/L. The 96 hour LC50 of 1.34 mg/L was determined by dividing the 96 hour LC0 and LC100 values (Bruns et al, 1992). Due to the similar structural, physical and chemical properties of amyl salicylate, it was considered appropriate for the purposes of read-across to hexyl salicylate.

Key value for chemical safety assessment

LC50 for freshwater fish:
1.34 mg/L

Additional information

The acute toxicity of Hexyl Salicylate to fish was determined. Danio rerio were exposed to the test media at nominal test concentrations of: 0, 1, 10 and 100 mg/L. This study was carried out to OECD Guideline 203 but there are many deviations from the guideline. There are many deviations in this study. The concentration range varied by a spacing factor greater than 2.2. Only four test concentrations were used. There is no indication of the actual test concentration of evidence that the concentration has been maintained throughout the test. The test item was tested over the limit of solubility, without specific preparation. The feeding of the fish was stopped 52 hours before the test and not 24 hours as recommended in the guideline.

A read-across report was also provided as support for this data point. The acute toxicity of amyl salicylate to Danio rerio was determined. Based on mean measured concentrations the 96 hour LC0 was determined to be 0.95 mg/L, the corresponding 96 hour LC100 was determined to be 1.90 mg/L. The 96 hour LC50 of 1.34 mg/L was determined by dividing the 96 hour LC0 and LC100 values. Due to the similar structural, physical and chemical properties of amyl salicylate, it was considered appropriate for the purposes of read-across to hexyl salicylate.