1,2-dichloro-3-nitrobenzene

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Justification for type of information:

Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87)

Qualifier:

according to guideline

Guideline:

other: protocol of the Dutch Standards Organisation, NEN 6501 (1980)

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

yes

Details on test solutions:

- stock solution was prepared in dimethylsulfoxide (DMSO; merck, purity 99%)

Test organisms (species):

Daphnia magna

Details on test organisms:

- daphnids were fed on 1x10E8 cells/l of Chlorella pyrenoidosa

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4.2 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

not specified

Remarks on result:

other: 95% CL: 3.2-5.6

Validity criteria fulfilled:

not specified

Conclusions:

In a short-term toxicity tests on crustaceans (D. magna) in analogy with the Dutch national standard method NEN6501 an EC50 value of 4.2 mg/l after a 2 days exposure period was obtained.

Executive summary:

In a short-term toxicity tests on crustaceans (D. magna) in analogy with the Dutch national standard method NEN6501 an EC50 value of 4.2 mg/l  after a 2 days exposure period was obtained.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Justification for type of information:

Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87)

Qualifier:

according to guideline

Guideline:

other: protocol of the Dutch Standards Organisation, NEN 6501 (1980)

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- species: Daphnia magna
- Age at study initiation (mean and range, SD): < 24 hours
- Feeding during test
- Food type: Chlorella pyrenoidosa (concentration at the start of the experiment: 1 X 10E8 cells/l)

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Hardness:

200 mg/l as CaCO3

Test temperature:

20 +/- 0.5°C

pH:

8.4 +/- 0.1

Dissolved oxygen:

synthetic test medium was saturated with air prior to use

Nominal and measured concentrations:

Test concentrations increased geometrically with a factor of 3.2.

Details on test conditions:

- illumination: 12 h/d

Duration:

48 h

Dose descriptor:

IC50

Effect conc.:

4.2 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

- the result published in the paper is log IC50 = 1.34 µmol/l

- the result mentioned above was calculated by the applicant based on the reported log IC50

 

 

Validity criteria fulfilled:

yes

Remarks:

validity criteria were fulfilled during the test - oxygen content of all solutions did not decrease below 7.9 mg/l (85%) - mortality in the controls never exceeded 10%

Conclusions:

In a short-term toxicity tests on crustaceans (D. magna) in analogy with the Dutch national standard method NEN6501 an IC50 (immobilisation) value of 4.2 mg/l (nominal concentration) after a 2 days exposure period was obtained.

Executive summary:

In a short-term toxicity tests on crustaceans (D. magna) in analogy with the Dutch national standard method NEN6501 an IC50 (immobilisation) value of 4.2 mg/l (nominal concentration) after a 2 days exposure period was obtained.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Justification for type of information:

Due to insufficient reporting of the experimental details, this study was rated with a Klimisch score of 4 (‘not assignable’). As none of the available studies can serve as a key study with a sufficiently detailed reporting justifying a Klimisch score of 1 or 2 for the given endpoint, several independent sources were used in a weight of evidence approach. ‘Using weight of evidence implies that no single study of sufficient quality and reliability exists, and that information from several independent sources is required to be able to reach a conclusion on a particular property of the substance.’ (guidance document How to prepare registration and PPORD dossiers, p. 87)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

=> proposal to short-term toxicity tests performed on crustaceans (Daphnia magna) (1979)

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Details on test conditions:

- due to the volatile character of 2,3-Dichloronitrobenzene (see "any other information on materials and methods incl. tables") the substance was tested in closed system

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

All test results were corrected for the actual concentration during the test.

Validity criteria fulfilled:

not specified

Conclusions:

In a short-term toxicity tests on crustaceans (D. magna) in analogy with the OECD 202 proposal (1979) an EC 50 (immobilisation) value of 1.6 mg/l after a 2 days exposure period was obtained.

Executive summary:

Canton et al. (1985) carried out short-term toxicity tests on crustaceans (D. magna) in analogy with the OECD 202 proposal (1979). The authors determined an EC 50 (immobilisation) value of 1.6 mg/l after a 2 days (48 h) exposure period.

Description of key information

In order to fulfill the data requirements a weight of evidence (WoE) approach (REACh Regulation (EC) No. 1907/2006, Annex XI Section 1.2) was chosen. This approach is a possible adaptation to the standard information requirements which ‘should be undertaken to maximise the use of existing data and minimise the commissioning of new in vivo testing’ (ECHA Guidance R.7a, 2017, p. 364). The WoE approach serves to reduce or avoid animal testing, which should only be performed as last resort (REACh, article 25). The individual study reports were conducted in accordance with standardized guidelines. The study reports nevertheless show some deficiencies with respect to the comprehensiveness of the presented experimental details. Therefore, a reliability of 1 or 2 and thus adequacy as key study was not assignable for any of the individual studies. Consequently, the studies were assigned a Klimisch score of 4 (according to guidance document R.4, ‘not assignable: studies or data […] which do not give sufficient experimental details […]). Collectively, these experimental studies can be used to conclude on this endpoint and to satisfy the information requirement. The studies by Canton (1985), Wellens (1987) and Deneer (1989) were part of the BUA report 1990 which is regarded as peer-reviewed source.

The following studies were chosen for WoE:
Canton et al. (1985) carried out short-term toxicity tests on crustaceans (D. magna) in analogy with the OECD 202 proposal (1979). The authors determined an EC 50 (immobilisation) value of 1.6 mg/l after a 2 days (48 h) exposure period.

According to Deneer et al. (1989) an IC50 value of 4.2 mg/l after a 2 days exposure period was obtained in a short-term toxicity tests on crustaceans (D. magna) in analogy with the Dutch national standard method NEN6501.

The same value of 4.2 mg/l (EC50) after 2 days exposure period was reported by Maas-Diepeveen et al. (1986) in a short-term toxicity test on D. magna in analogy with the Dutch national standard method NEN6501.

The results obtained by Wellens et al. (1989) and those cited in the SIDS report 2002 were  included in the WoE approach despite being considered not  reliable (Klimisch 3) due to methodological deficiencies. The reported 24-h EC50 values are in the same order of magnitude. 

Wellens 1987: A 24-h acute toxicity test with Daphnia magna was performed according to guideline DIN 38412, part 11. The reported LC50 (24h) value is 5.6 mg/L (reported as ppm (w/v)). Due to methodological deficiencies (the exposure time was too short: 24 h instead of the required 48h), the study was assigned a Klimisch score of 3 (not reliable). 

SIDS final assesment report, 2002: A 24-h acute toxicity test with Daphnia magna was performed according to OECD guideline. Tested 1,2-dichloro-3-nitrobenzene had a purity of >99%. The reported LC50 (24h) value is 5 mg/L (reported as ppm (w/v)). Data was obtained from an unpublished report (Report on Toxicity to Fish-HPV/SIDS test conducted by the EA). Due to methodological deficiencies (the exposure time was too short: 24 h instead of the required 48h), the study was assigned a Klimisch score of 3 (not reliable). 

Conclusion
The EC50 values obtained from these studies are in the same order of magnitude (48h EC50/IC50 range: 1.6-4.2 mg/L; 24h EC50: 5-5.6 mg/L). The most conservative value of 1.6 mg/L is chosen as key value for assessment.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

1.6 mg/L