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EC number: 203-026-2 | CAS number: 102-36-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- 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:
- other: Guideline study, basic data given, peer reviewed in BUA Report
- 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)
For further details on the justification for the use of data on the hydrolysis product 3,4-dichloroaniline please refer to chapter 13.2. - Principles of method if other than guideline:
- Method: other: DIN 38412, Teil 11
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- The hydrolysis of 3,4-dichlorophenyl isocyanate is expected to occur faster than within 12 h (Please refer to the expert statement in section 13.) Thus, it is technically not feasible to conduct toxicity tests towards the aquatic species with the test item 3,4-dichlorophenyl isocyanate, as the hydrolysis will take place fully, well before the regular test medium is exchanged. The short-term toxicity towards aquatic invertebrates and toxicity towards algae was therefore investigated using the hydrolysis product 3,4-dichloronaniline.
- Analytical monitoring:
- not specified
- Test organisms (species):
- Daphnia magna
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Duration:
- 24 h
- Dose descriptor:
- EC0
- Effect conc.:
- 1.3 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 4.3 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- 10 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 0.63 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.8 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 10 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- For Daphnia magna, an EC50 of 2.8 mg/l after 48 h of exposure was obtained for 3,4-dichloroaniline (the main hydrolysis product of 3,4-dichlorophenyl isocyanate).
- Executive summary:
Kühn, 1989
The acute toxicity of 3,4-dichloroaniline, the main hydrolysis product of 3,4-dichlorophenyl isocyanate, was assessed (static, freshwater test following DIN 38412, Teil 11). For Daphnia magna, an EC50 of 2.8 mg/l after 48 h of exposure was obtained.
- 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:
- other: Only basic data given, peer reviewed in BUA report.
- 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)
For further details on the justification for the use of data on the hydrolysis product 3,4-dichloroaniline please refer to chapter 13.2. - Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Method: Semistatic Test system
- GLP compliance:
- no
- Specific details on test material used for the study:
- The hydrolysis of 3,4-dichlorophenyl isocyanate is expected to occur faster than within 12 h (Please refer to the expert statement in section 13.) Thus, it is technically not feasible to conduct toxicity tests towards the aquatic species with the test item 3,4-dichlorophenyl isocyanate, as the hydrolysis will take place fully, well before the regular test medium is exchanged. The short-term toxicity towards aquatic invertebrates and toxicity towards algae was therefore investigated using the hydrolysis product 3,4-dichloronaniline.
- Analytical monitoring:
- not specified
- Vehicle:
- yes
- Details on test solutions:
- - Chemical name of vehicle: Ethanol
- Test organisms (species):
- Daphnia magna
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 30 d
- Test temperature:
- 18- 22 °C
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.12 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Validity criteria fulfilled:
- not specified
- Conclusions:
- For Daphnia magna, a LC50 of 0.12 mg/l after 96 h of exposure was obtained for 3,4-dichloroaniline (the main hydrolysis product of 3,4-dichlorophenyl isocyanate).
- Executive summary:
Van der Meer, 1988
The acute toxicity of 3,4-dichloroaniline, the main hydrolysis product of 3,4-dichlorophenyl isocyanate, was assessed (semi-static, freshwater test). For Daphnia magna, a LC50 of 0.12 mg/l after 96 h of exposure was obtained.
- 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:
- other: Peer reviewed data, cited in EU Risk 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)
For further details on the justification for the use of data on the hydrolysis product 3,4-dichloroaniline please refer to chapter 13.2. - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- no
- Specific details on test material used for the study:
- The hydrolysis of 3,4-dichlorophenyl isocyanate is expected to occur faster than within 12 h (Please refer to the expert statement in section 13.) Thus, it is technically not feasible to conduct toxicity tests towards the aquatic species with the test item 3,4-dichlorophenyl isocyanate, as the hydrolysis will take place fully, well before the regular test medium is exchanged. The short-term toxicity towards aquatic invertebrates and toxicity towards algae was therefore investigated using the hydrolysis product 3,4-dichloronaniline.
- Analytical monitoring:
- not specified
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Aliquotes of stock solutions of DCA in analytical grade acetone were added to give an approximately logarithmic series of concentrations.
The concentrations of acetone was adjusted to 0.5 mg/L. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Source: Culture derived from a strain optained from the Institute National de Recherche Chimique Applique, France
- Age at study initiation: < 24 h - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 ml glass beakers, 100 ml fill volume
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): 3
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: filtered chlorinated tap water. - Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.29 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- For Daphnia magna, an EC50 of 0.29 mg/l after 48 h of exposure was obtained for 3,4-dichloroaniline (the main hydrolysis product of 3,4-dichlorophenyl isocyanate).
- Executive summary:
Crossland, 1985
The acute toxicity of 3,4-dichloroaniline, the main hydrolysis product of 3,4-dichlorophenyl isocyanate, was assessed (static, freshwater test similar to OECD TG 202). For Daphnia magna, an EC50 of 0.29 mg/l after 48 h of exposure was obtained.
- 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:
- other: Test procedure in accordance with national standard methods with acceptable restrictions. Peer-reviewed data from EU-RAR of the hydrolysis product 3,4-dichloroaniline.
- 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)
For further details on the justification for the use of data on the hydrolysis product 3,4-dichloroaniline please refer to chapter 13.2. - Principles of method if other than guideline:
- national standard method: described in handbook "Degradability, Ecotoxicity and Bioaccumulation; The determination of the possible effects of chemicals and wastes on the aquatic environment (TNO, 1980)"
- GLP compliance:
- no
- Specific details on test material used for the study:
- The hydrolysis of 3,4-dichlorophenyl isocyanate is expected to occur faster than within 12 h (Please refer to the expert statement in section 13.) Thus, it is technically not feasible to conduct toxicity tests towards the aquatic species with the test item 3,4-dichlorophenyl isocyanate, as the hydrolysis will take place fully, well before the regular test medium is exchanged. The short-term toxicity towards aquatic invertebrates and toxicity towards algae was therefore investigated using the hydrolysis product 3,4-dichloronaniline.
- Analytical monitoring:
- yes
- Details on sampling:
- at test start
- Vehicle:
- not specified
- Test organisms (species):
- Daphnia magna
- Test type:
- not specified
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- hard
- Test temperature:
- 19°C
- pH:
- about 8
- Dissolved oxygen:
- never less than 70 % of the saturation value
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Remarks:
- 1 mm, larvae
- Effect conc.:
- 0.23 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Remarks:
- 1 mm, larvae
- Effect conc.:
- 0.16 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 7 d
- Dose descriptor:
- LC50
- Remarks:
- 1 mm, larvae
- Effect conc.:
- 0.12 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Remarks:
- 3 mm, adults
- Effect conc.:
- 12 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Remarks:
- 3 mm, adults
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 7 d
- Dose descriptor:
- LC50
- Remarks:
- 3 mm, adults
- Effect conc.:
- < 0.58 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Validity criteria fulfilled:
- not specified
- Conclusions:
- For Daphnia magna, a LC50 of 0.23 mg/l (larvae, 1 mm) after 48 h of exposure was obtained for 3,4-dichloroaniline (the main hydrolysis product of 3,4 -dichlorophenyl isocyanate).
- Executive summary:
Adema, 1981
The acute toxicity of 3,4-dichloroaniline, the main hydrolysis product of 3,4-dichlorophenyl isocyanate, was assessed following a national standard method for the determination of toxicity to invertebrates. For Daphnia magna, a LC50 of 0.23 mg/l (larvae, 1 mm) after 48 h of exposure was obtained.
Referenceopen allclose all
-the concentration of the test compound in the water was measured by chemical analysis during the test and was at least 70% of the nominal value
Description of key information
For 3,4-dichlorophenyl isocyanate no short-term tests on toxicity to invertebrates are available. Therefore, the short-term toxicity test of the main hydrolysis product 3,4-dichloroaniline with the lowest value is used to draw a conclusion on toxicity to invertebrates for the parent compound. For further details please refer to chapter 13.2.
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.
Adema, 1981
The acute toxicity of 3,4-dichloroaniline was assessed following a national standard method for the determination of toxicity to invertebrates. For Daphnia magna, a LC50 of 0.23 mg/l (larvae, 1 mm) after 48 h of exposure was obtained.
Van der Meer, 1988
The acute toxicity of 3,4-dichloroaniline, the main hydrolysis product of 3,4-dichlorophenyl isocyanate, was assessed (semi-static, freshwater test). For Daphnia magna, a LC50 of 0.12 mg/l after 96 h of exposure was obtained.
Kühn, 1989
The acute toxicity of 3,4-dichloroaniline, the main hydrolysis product of 3,4-dichlorophenyl isocyanate, was assessed (static, freshwater test following DIN 38412, Teil 11). For Daphnia magna, an EC50 of 2.8 mg/l after 48 h of exposure was obtained.
Crossland, 1985
The acute toxicity of 3,4-dichloroaniline, the main hydrolysis product of 3,4-dichlorophenyl isocyanate, was assessed (static, freshwater test similar to OECD TG 202). For Daphnia magna, an EC50 of 0.29 mg/l after 48 h of exposure was obtained.
Conclusion
The EC50/LC50 values obtained from these studies are in the same order of magnitude.
48h-EC50/LC50: 0.23 - 2.8 mg/l
96-h LC50: 0.12 mg/l
The most conservative EC50 of 0.23 mg/l (Adema, 1981) obtained for the standard exposure time of 48h as outlined in OECD 202 was chosen as key value for chemical safety assessment.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- LC50
- Effect concentration:
- 0.23 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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