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Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

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Additional information

Conclusion on classification

1) Classification of 2,3-dichloroaniline (> 99.0%), pure relevant for the justification of a M-factor.


According to Annex VI to EC1272/2008, 2,3-dichloroaniline (> 99.0%) as a chloroaniline substance is classified as Aquatic Acute 1 and Aquatic Chronic 1 (index No. 612-010-00-8). Since no reliable acute and chronic aquatic toxicity studies are available for the 2,3-dichloroaniline, aquatic toxicity data of structure analogue substance 3,4-dichloroaniline is applied for setting the multiplying factor (M-factor) for 2,3-dichloroaniline (> 99.0%). Toxicity against Daphnia was determined for 3,4-dichloroaniline (Adema, DMM and Vink, GJ (1981), EU RAR (2006)). The EC50 value was determined to be 0.23 mg/L, which corresponds to an M-factor of 1 for aquatic toxicity.


As a reference, according to the Draft of 2nd ATP (18. Oct. 2008) to the Regulation (EC) 1272/2008 (CLP), an M-factor of 10 is assigned for 2,3-dichloroaniline based on chronic daphnia toxicity (RA to 3,4 -DCA, NOEC: 0.005 mg/L ) and not readily biodegradable.


 


2) Classification of 2,3-dichloroaniline, raw


The product 2,3-dichloroaniline, raw contains 2,3-dichloroaniline as main constituent and various chloroanilines, dichloroaniline isomers, as well as aniline, as impurities. Same as the main constituent of 2,3-dichloroaniline, all these impurities are included in Annex VI table 3.1 and Table 3.2 and classified as Aquatic Acute 1 and Aquatic Chronic 1 (see Section 1.2). In accordance with Regulation (EC) No 1272/2008, the product 2,3-dichloroaniline, raw needs to be classified as Aquatic Acute 1 and Aquatic Chronic 1, accordingly. Application of the additivity formula is not necessary, since the concentration and M-factor of any component contained do not affect the classification of the product. Since the impurities contained in 2,3-dichloroaniline, raw are classified as Acute Category 1 and Chronic Category 1 according to the Annex VI of CLP, each M-factor is indicated based on available literature data in Table 6 (see attached document in section 13: "Justification for setting a M-factor").


In addition to M-factors for acute aquatic toxicity, M-factors for chronic aquatic toxicity as reference are established based on literature data on biodegradation and chronic aquatic toxicity in accordance with the Draft of 2. ATP to the Regulation (EC) No 1272/2008 (18. Oct 2010).


 


3) Classification of 2,3-dichloroaniline based on read across from 3,4-dichloroaniline


Read-across approach data on 3,4-dichloroaniline (CAS 95-76-1, source substance) is used to fill data gaps for the structural isomer 2,3-dichloroaniline (CAS 608-27-5, target substance), in accordance with Regulation No 1907/2006 (REACH), Annex XI in Aquatic toxicity endpoint. Based on the structural similarity, the similar physico-chemical properties, and the fact that the structural difference in the source substance indicates a slightly higher toxicity when compared to the target substance, the target substance as such does not need to be tested in aqueous system. It is sufficient for hazard assessment to use the data gained with 3,4-dichloroaniline. As a conclusion, test item will be classified as Aquatic Acute 1 and Aquatic Chronic 1 in accordance with Regulation (EC) No 1272/2008 for the worst-case scenario.