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Diss Factsheets
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EC number: 209-057-8 | CAS number: 554-00-7
- 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
Endpoint summary
Administrative data
Description of key information
Key, guinea pig maximisation test, read across to 3,4 dichloroaniline, positive
Supp, QSAR, Danish QSAR database, battery model, positive
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
please see attached justification statement - Reason / purpose for cross-reference:
- read-across source
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
none- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
4 animals with discrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
1 animal with dicrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
14 animals with discrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
5 animals with discrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- 17 animals with discrete or patchy erythema
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
7 animals with discrete or patchy erythema, 1 animal with moderate and confluent erythema- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
13 animals with discrete or patchy erythema, 6 animals with moderate and confluent erythema- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
7 animals with discrete or patchy erythema- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
11 animals with discrete or patchy erythema, 4 animals with moderate and confluent erythema and 3 animals with intense erythema and swelling- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
9 animals with discrete or patchy erythema- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
15 animals with moderate to confluent erythema; 5 animals with discrete or patchy erythema- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- 3,4 -dichloroaniline was found to be sensitising in this guinea pig maximisation test.
- Executive summary:
3,4 -dichloroaniline was tested for skin sensitisation according to OECD Guideline 406 in a Magnusson and Kligman test in male guinea pigs. Although irritation was also evident in the control group after challenge or rechallenge with either 50, 25 or 5 % 3,4 -dichloroaniline in propylene glycol (w/w) the incidence and severity of irritation was always higher in the induced test group. Therefore 3,4 -dichloroaniline was concluded to be sensitising in this guinea pig maximisation test. Based on the read across approach, this result is also fully applicable to the registered substance 2,4 -dichloroaniline (for more information please refer to the Read Across Statement attached in Section 13).
Reference
During the range finding test for the challenge concentration acute dermal toxicity was observed after simultaneous exposure of each of five guinea pigs to 4 occlusive gauze patches treated with either 0.5 mL 6, 12, 25 or 50 % 3,4 -dichloroaniline in propylene glycol. Two animals were found dead after 24 h and the remaining three were euthanized for animal welfare reasons due to severe signs of toxicity.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Guinea pig maximisation Test - Read across to 3,4 -dichloroaniline
3,4 -dichloroaniline was tested for skin sensitisation according to OECD Guideline 406 in a Magnusson and Kligman test in male guinea pigs. Although irritation was also evident in the control group after challenge or rechallenge with either 50, 25 or 5 % 3,4 -dichloroaniline in propylene glycol (w/w) the incidence and severity of irritation was always higher in the induced test group. Therefore 3,4 -dichloroaniline was concluded to be sensitising in this guinea pig maximisation test. Based on the read across approach, this result is also fully applicable to the registered substance 2,4 -dichloroaniline (for more information please refer to the Read Across Statement attached in Section 13).
QSAR prediction
Skin sensitisation was predicted using the models Sci QSAR and CASE ULtra implemented in the Danish data base and the OECD QSAR toolbox v4.5. Positive indication of skin sensitisation was given by these QSAR predictions. The final result was drawn from the overall prediction of the battery model that contains 3 different models, for skin sensitisation implemented in the Danish QSAR database. For the Sci QSAR model and the CASE Ultra QSAR model the substance was predicted positive and the predictions fall in the applicability domain. The third model of the battery (Leadscope) could not make a prediction, as the substance was out of the applicability domain of the model.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the registered substance is classified as skin sens 1 (H317) in accordance with Regulation (EC) No 1272/2008.
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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