1,2,4-trichlorobenzene

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

other: EU Risk Assessment

Adequacy of study:

other information

Reliability:

other: EU Risk Assessment

Rationale for reliability incl. deficiencies:

other: no reliability is given as this is a summary entry for the EU RAR

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

EU Risk Assessment

GLP compliance:

not specified

Sublethal observations / clinical signs:

EU Risk Assessment (2003):

 

The LC50 values for short-term toxicity to fish rang between 1,217 mg/l (Smith et al., 1991) and 12,3 mg/l (MITI, 1992) excluding the key study with a LC50 of 0,7 mg/l (Knie et al., 1983). In most cases the test duration was 96 h but there are also valid results from 48 h lasting studies.

 

Several short-term studies on toxicity of 1,2,4-TCB to fish have been performed in the past but not all of them are mentioned in the EU RAR due to two main deficiencies caused by the volatile and poorly water soluble nature of the substance.

1.) Generally, the results from static tests have been excluded due to the nature of the chemical (volatilisation) unless measured data are present or closed systems have been used. The problem is illustrated in the study by Smith et al. (1991), which observed the EC50 (96 h) of 4.0 mg/l in a static test and 1.2 mg/l in a flow through test using measured concentrations.

2.) Other reasons for excluding certain studies are observations of undissolved test substance in test medium (e.g. Buccafuco et al., 1981).

 

1,2,4-TCB has an acute non-specific toxic effect via narcosis (Veith et al., 1983).

 

Regarding the acute toxicity to fish, a value from the lower end of tests with measured

concentrations is used in the risk assessment: LC50 (96 h) of 1.0 mg/l.

 

This value is in general agreement with QSAR estimation according to the TGD (1996) which

results in a fish (96 h) LC50 of 2.7 mg/l for non-polar narcotic acting substances and QTOXMIN (Pedersen et al., 1995) estimation which result in LC50 (96 h) of 2.5 mg/l. The ECOSAR model, which is a computer program for estimating the ecotoxicity of industrial chemicals based on structure activity relationships, estimates a freshwater fish LC50 (96 h) to be 1.6 mg/l (US EPA, 1994). The QSAR predictions fit well with the experimental data.

 

The proposal for classification for N; R50-53 was based on the fact that whilst many of the measured data points lie in the R51 (1-10 mg/l range), there are sufficient data from both fish, crustaceans and other aquatic organisms below 1 mg/l to justify suggesting this classification. It should also be noted that 1,2-dichlorobenzene is classified as N; R50-53 in Annex I of Directive 67/548/EEC, and that the same classification has been proposed for 1,4-dichlorobenzene.

Executive summary:

EU Risk Assessment (2003):

The LC₅₀ values for short-term toxicity to fish rang between 1,217 mg/L (Smith et al., 1991) and 12,3 mg/L (MITI, 1992) excluding the key study with a LC₅₀ of 0,7 mg/L (Knie et al., 1983). In most cases the test duration was 96 h but there are also valid results from 48 h lasting studies.

 

Several short-term studies on toxicity of 1,2,4-TCB to fish have been performed in the past but not all of them are mentioned in the EU RAR due to two main deficiencies caused by the volatile and poorly water soluble nature of the substance.

1.) Generally, the results from static tests have been excluded due to the nature of the chemical (volatilisation) unless measured data are present or closed systems have been used. The problem is illustrated in the study by Smith et al. (1991), which observed the EC50 (96 h) of 4.0 mg/l in a static test and 1.2 mg/l in a flow through test using measured concentrations.

2.) Other reasons for excluding certain studies are observations of undissolved test substance in test medium (e.g. Buccafuco et al., 1981).

 

1,2,4-TCB has an acute non-specific toxic effect via narcosis (Veith et al., 1983).

 

Regarding the acute toxicity to fish, a value from the lower end of tests with measured

concentrations is used in the risk assessment: LC50 (96 h) of 1.0 mg/l.

 

This value is in general agreement with QSAR estimation according to the TGD (1996) which

results in a fish (96 h) LC50 of 2.7 mg/l for non-polar narcotic acting substances and QTOXMIN (Pedersen et al., 1995) estimation which result in LC50 (96 h) of 2.5 mg/l. The ECOSAR model, which is a computer program for estimating the ecotoxicity of industrial chemicals based on structure activity relationships, estimates a freshwater fish LC50 (96 h) to be 1.6 mg/l (US EPA, 1994). The QSAR predictions fit well with the experimental data.

 

The proposal for classification for N; R50-53 was based on the fact that whilst many of the measured data points lie in the R51 (1-10 mg/l range), there are sufficient data from both fish, crustaceans and other aquatic organisms below 1 mg/l to justify suggesting this classification. It should also be noted that 1,2-dichlorobenzene is classified as N; R50-53 in Annex I of Directive 67/548/EEC, and that the same classification has been proposed for 1,4-dichlorobenzene.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

other: EU Risk Assessment

Adequacy of study:

other information

Reliability:

other: EU Risk Assessment

Rationale for reliability incl. deficiencies:

other: no reliability is given as this is a summary entry for the EU RAR

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

EU Risk Assessment

GLP compliance:

not specified

Sublethal observations / clinical signs:

EU Risk Assessment (2003):

 

This endpoint study record was only created for further reference entries (>10) belonging to "6.1.1., rel other, EU Risk Assessment, 2003 (part 1/2)".

Executive summary:

EU Risk Assessment (2003):

This endpoint study record was only created for further reference entries (>10) belonging to "6.1.1., other, EU Risk Assessment, 2003 (part 1/2)".

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

other: BUA report

Adequacy of study:

other information

Reliability:

other: BUA report

Rationale for reliability incl. deficiencies:

other: no reliability is given as this is a summary entry for the BUA report

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

BUA report

GLP compliance:

not specified

Sublethal observations / clinical signs:

BUA report (1987):

 

The LC50 values for fish are between < 1 (Simmons et al., 1977) and 109 mg/l (Buccafusco et al., 1981) excluding the key study with a LC50 of 0,7 mg/l (Knie et al., 1983). The procedure used for the test is decisively important here; this explains why such large differences have been found.

Executive summary:

BUA report (1987):

 

The LC₅₀ values for fish are between < 1 (Simmons et al., 1977) and 109 mg/L (Buccafusco et al., 1981) excluding the key study with a LC₅₀ of 0,7 mg/L (Knie et al., 1983). The procedure used for the test is decisively important here; this explains why such large differences have been found.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

other: BUA report

Adequacy of study:

other information

Reliability:

other: BUA report

Rationale for reliability incl. deficiencies:

other: no reliability is given as this is a summary entry for the BUA report

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

BUA report

GLP compliance:

not specified

Sublethal observations / clinical signs:

BUA report (1987):

 

This endpoint study record was only created for further reference entries (>10) belonging to "6.1.1, rel other, BUA report 17, 1987 (part 1/2)".

Executive summary:

BUA report (1987):

This endpoint study record was only created for further reference entries (>10) belonging to "6.1.1, other, BUA report 17, 1987 (part 1/2)".

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

other: applicant's summary entry for further information

Adequacy of study:

other information

Reliability:

other: applicant's summary entry for further information

Rationale for reliability incl. deficiencies:

other: no reliability is given as this is an applicant's summary entry for further information

Principles of method if other than guideline:

applicant's summary entry for further information

GLP compliance:

not specified

Sublethal observations / clinical signs:

applicant's summary entry for further information:

 

The Hoechst AG determined a LC50 of 11 mg/l on Danio rerio. A NOEC of 0.04 mg/l and a LC100 of 1.9 mg/l was determinde for Danio rerio in a study according to a method of the German Umweltbundesamt (UBA, I 4.5 - 97125 -2/6, 06.05.1982). Bayer AG conducted several laboratory studies on acute toxicity to fish in 1974 and 1985. Due to insufficient documentation and methodological deficiencies the results of this tests are not valid.

Executive summary:

applicant's summary entry for further information:

 

The Hoechst AG determined a LC₅₀ of 11 mg/L on Danio rerio. A NOEC of 0.04 mg/L and a LC₁₀₀ of 1.9 mg/L was determinde for Danio rerio in a study according to a method of the German Umweltbundesamt (UBA, I 4.5 - 97125 -2/6, 06.05.1982). Bayer AG conducted several laboratory studies on acute toxicity to fish in 1974 and 1985. Due to insufficient documentation and methodological deficiencies the results of this tests are not valid.

Reference 6

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

not specified

Test organisms (species):

Oryzias latipes

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4.9 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4.8 mg/L

Executive summary:

Yoshioka, 1993:

The short-term toxicity to fish Oryzias latipes was investigated and the following effect concentration was reported:
LC50 (48h): 4.9 mg/L.
LC50 (96h): 4.8 mg/L.

Reference 7

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

GLP compliance:

not specified

Test organisms (species):

Lepomis macrochirus

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

13 mg/L

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

3.6 mg/L

Executive summary:

US EPA, 1985:

The short-term toxicity to fish Lepomis macrochirus was investigated and the following effect concentration was reported:
LC50 (48h): 13 mg/L.
LC50 (72h): 3.6 mg/L.

Reference 8

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available. ( reliability was 1)

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.32 mg/L

Executive summary:

Sulaiman, 1993:

The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 1.32 mg/L.

 

Reference 9

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

not specified

Test organisms (species):

Fundulus sp.

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.4 mg/L

Executive summary:

Niinomi, 1989:

The short-term toxicity to fish was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 2.4 mg/L.

Reference 10

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1995

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Remarks:

GLP - Guideline study, only results are published, detailed study report not available

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

not specified

GLP compliance:

yes

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Oryzias latipes

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.4 mg/L

Sublethal observations / clinical signs:

The National Institute of Technology and Evaluation (NITE) of Japan tested Orizias latipes and found in a GLP conforme study according to OECD TG 203 a LC50 of 2.4 mg/l. This low EC50 value supports the result of the key study (Knie et al., 1983).

Executive summary:

NITE Japan, 1995:

The National Institute of Technology and Evaluation (NITE) of Japan tested Orizias latipes and found in a GLP conforme study according to OECD TG 203 a LC50 of 2.4 mg/L. This low EC₅₀ value supports the result of the key study (Knie et al., 1983).

Reference 11

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Study period:

not given

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Remarks:

National Guideline study with acceptable restrictions, basic data given, only 48 h value reported

Qualifier:

according to guideline

Guideline:

other: DIN 38412-15

GLP compliance:

not specified

Vehicle:

not specified

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: DIN 38412 Teil 15

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name (German): Goldorfe

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

0.6 mg/L

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

0.7 mg/L

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

0.8 mg/L

Validity criteria fulfilled:

not specified

Executive summary:

Knie, 1983:

 

This study reports the most critical and valid published LC₅₀ for short term toxicity of 1,2,4 -TCB to fish. The study was performed in accordance to the National German Guideline DIN 38412 -15. Unfortunately the publication doesn't provide detailed information on test method. The very low LC50 of 0,7 mg/l after 48 hours of testing reveals a very high short term toxicity of 1,2,4 -TCB to fish. For this reason 1,2,4 -TCB is classified as "very toxic to aquatic organisms" (ATP 28).

 

Amongst others the study result of Knie et al. is cited as valid in the EU Risk Assessment Report (2003) and in the German BUA Report (1987) of 1,2,4 -TCB.

Reference 12

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

GLP compliance:

not specified

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.8 mg/L

Executive summary:

Halfon, 1986:

The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 1.8 mg/L.

Reference 13

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

Principles of method if other than guideline:

Method: other: Standard Methods for the Examination of Water and Wastewater. 13th Ed., Amer. Publ. Health Assn., Washington, D.C. (1971)

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

other: Notemigigonus chrysoleuicas

Test type:

static

Dose descriptor:

LC50

Effect conc.:

1 mg/L

Reference 14

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

not specified

Analytical monitoring:

no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4.2 mg/L

Executive summary:

Douglas, 1986:

The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 4.2mg/L.

Reference 15

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.3 mg/L

Executive summary:

Ahmad 1984:

The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 1.3mg/L.

Description of key information

For transported isolated intermediates according to REACh, Article 18, this endpoint is not a data requirement. However, data is available for this endpoint and is thus reported under the guidance of "all available data".

 

Generally, following values have been reported for the LC50 after 96h exposure time:

LC₅₀ 96h: 1.0 - 4.8 mg/L

 

Knie, 1983:
This study reports the most critical and valid published LC50 for short term toxicity of 1,2,4 -TCB to fish. The study was performed in accordance to the National German Guideline DIN 38412 -15. Unfortunately the publication doesn't provide detailed information on test method. The very low LC50 of 0.7 mg/l after 48 hours of testing reveals a very high short term toxicity of 1,2,4 -TCB to fish. For this reason 1,2,4 -TCB is classified as "very toxic to aquatic organisms" (ATP 28).

NITE Japan, 1995:
The National Institute of Technology and Evaluation (NITE) of Japan tested Orizias latipes and found in a GLP conforme study according to OECD TG 203 a LC₅₀ of 2.4 mg/L. This low value supports the result of the study of Knie et al., 1983.

EU Risk Assessment (2003):
The LC50 values for short-term toxicity to fish rang between 1.217 mg/L (Smith et al., 1991) and 12.3 mg/L (MITI, 1992) excluding the key study with a LC50 of 0.7 mg/L (Knie et al., 1983). In most cases the test duration was 96 h but there are also valid results from 48 h lasting studies.
Several short-term studies on toxicity of 1,2,4-TCB to fish have been performed in the past but not all of them are mentioned in the EU RAR due to two main deficiencies caused by the volatile and poorly water soluble nature of the substance.

1.) Generally, the results from static tests have been excluded due to the nature of the chemical (volatilisation) unless measured data are present or closed systems have been used. The problem is illustrated in the study by Smith et al. (1991), which observed the EC50 (96 h) of 4.0 mg/l in a static test and 1.2 mg/l in a flow through test using measured concentrations.

2.) Other reasons for excluding certain studies are observations of undissolved test substance in test medium (e.g. Buccafuco et al., 1981).
1,2,4-TCB has an acute non-specific toxic effect via narcosis (Veith et al., 1983).
Regarding the acute toxicity to fish, a value from the lower end of tests with measured concentrations is used in the risk assessment: LC50 (96 h) of 1.0 mg/l. This value is in general agreement with QSAR estimation according to the TGD (1996) which results in a fish (96 h) LC50 of 2.7 mg/l for non-polar narcotic acting substances and QTOXMIN (Pedersen et al., 1995) estimation which result in LC50 (96 h) of 2.5 mg/l. The ECOSAR model, which is a computer program for estimating the ecotoxicity of industrial chemicals based on structure activity relationships, estimates a freshwater fish LC50 (96 h) to be 1.6 mg/l (US EPA, 1994). The QSAR predictions fit well with the experimental data.
The proposal for classification for N; R50-53 was based on the fact that whilst many of the measured data points lie in the R51 (1-10 mg/l range), there are sufficient data from both fish, crustaceans and other aquatic organisms below 1 mg/l to justify suggesting this classification.

It should also be noted that 1,2-dichlorobenzene is classified as N; R50-53 in Annex I of Directive 67/548/EEC, and that the same classification has been proposed for 1,4-dichlorobenzene.

BUA report (1987):
The LC50 values for fish are between < 1 (Simmons et al., 1977) and 109 mg/L (Buccafusco et al., 1981) excluding the key study with a LC50 of 0.7 mg/L (Knie et al., 1983). The procedure used for the test is decisively important here; this explains why such large differences have been found.
applicant's summary entry for further information:
The Hoechst AG determined a LC50 of 11 mg/L on Danio rerio. A NOEC of 0.04 mg/L and a LC100 of 1.9 mg/L was determinde for Danio rerio in a study according to a method of the German Umweltbundesamt (UBA, I 4.5 - 97125 -2/6, 06.05.1982). Bayer AG conducted several laboratory studies on acute toxicity to fish in 1974 and 1985. Due to insufficient documentation and methodological deficiencies the results of this tests are not valid.

Ahmad 1984:
The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 1.3 mg/L.

Douglas, 1986:
The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 4.2 mg/L.

Halfon, 1986:
The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 1.8 mg/L.

Niinomi, 1989:
The short-term toxicity to fish was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 2.4 mg/L.

Sulaiman, 1993:
The short-term toxicity to fish (Oncorhynchus mykiss; previous name: Salmo gairdneri) was investigated over a period of 96h. The following effect concentration was reported: LC50 (96h): 1.32 mg/L.

US EPA, 1985:
The short-term toxicity to fish Lepomis macrochirus was investigated and the following effect concentration was reported:
LC50 (48h): 13 mg/L.
LC50 (72h): 3.6 mg/L.

Yoshioka, 1993:
The short-term toxicity to fish Oryzias latipes was investigated and the following effect concentration was reported:
LC50 (48h): 4.9 mg/L.
LC50 (96h): 4.8 mg/L.