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Short term toxicity to fish:

Based on the various studies available with Klimish rating 2 for the target substance CAS NO 99-97-8 The results is summarized as follows

Sr.No

Endpoint

Effect values

Basis for effects

Duration

Species

Remarks

1

TLm

44 mg/l

mortality

24 hrs

Oryzias latipes

Data from publication for target chemical

2

TLm

20 mg/l

mortality

24 hrs

Oryzias latipes

Data from publication for target chemical

3

LC50

52.8 mg/l

mortality

96hrs

Pimephales promelas

Data from publication for target chemical

4

LC50

EC50

52 mg/l

52 mg/l

mortality

96hrs

Pimephales promelas

Data from publication for target chemical

3

LC50

EC50

46 mg/l

41.5 mg/l

mortality

96hrs

Pimephales promelas

Data from publication for target chemical

 

By applying weight of evidence approach to the studies summarized in the above table it can be observed that the LC50 values was found to be in range of 46 to 52 mg/l in 96 hrs and the EC50 values was found to be in the range of 41.5 to 52 mg/l in 96 hrs. Also the Median Tolerence limit (TLm) value was found to be in the range of 20 to 44 mg/l in 24 hrs study on the basis of mortality effect. Since the substance was not found to be rapidly degradable. Thus considering the CLP Criteria for aquatic classification of the substance, it is concluded that N,N-dimethyl-p-toluidine exhibit short term toxicity to fish (Oryzias latipes,Pimephales promelas) in aquatic chronic category 3.

Long term toxicity to fish:

According to column 1 of Annex IX , long-term toxicity testing on fish was considered for waiver as short term toxicity data has already been provided as part of Annex VIII requirements in section 6.1.1 of this dossier

Short term toxicity to aquatic invertebrate:

Based on the various studies available with Klimish rating 2 and 4 for target chemical CAS NO 99-97-5 and the read across substances . The results is summarized as follows

 

Sr.No

Endpoint

Effect values

Basis for effects

Duration

Species

Remarks

1

LC50

15.259 mg/l

mortality

48 hrs

Daphnia magna

Predicted data for target chemical

2

EC50

23.758 mg/L.

 

mortality

48 hrs

Daphnia magna

Data from database

3

EC50

13.7 mg/L.

 

mortality

48 hrs

Daphnia magna

Data from publication for CAS no 121-69-7

 

By applying weight of evidence approach to the studies summarized in the above table, the EC50 value is expected to be in range of 13.7 to 23.758 mg/l and LC50 value was found to be 15.259 mg/l in 48 hrs study on the basis of mortality effect. Since N,N-dimethyl-p-toluidine is not found to be rapidly degradable. Thus according to CLP criteria of aquatic classification it is concluded that the substance N,N-dimethyl-p-toluidine is toxic to aquatic invertebrate (Daphnia magna)in aquatic chronic category 3

Long term toxicity to aquatic invertebrate:

According to column 1 of Annex IX , long-term toxicity testing on aquatic invertebrates was considered for waiver as short term toxicity data has already been provided as part of Annex VII requirements in section 6.1.3 of this dossier.

Toxicity to aquatic algae and cynobacteria:

Based on the various studies available with Klimish rating 2 and 4 for the target substance CAS NO 99-97-8 and read across substances and based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. The results is summarized as follows

 

Sr.No

Endpoint

Effect values

Basis for effects

Duration

Species

Remarks

1

EC50

15.481

 mg/l

growth rate

96 hrs hrs

Green algae

Data is from database

2

EC50

24.37mg/l

Growth

72 hrs

Pseudokirchneriella subcapitata

Predicted data of target chemcial 

3

EC50

22 mg/l

growth rate

72 hrs

Chlorella pyrenoidosa

Data from publication for CAS no 121-69-7

 

By applying weight of evidence approach to the studies summarized in the above table it can be observed that EC50 value is expected to be in range of15.481 to24.37 mg/l in 72 hrs to 96 hrs study on the basis of growth rate. Sincesubstance was not found to be rapidly degradable.Thus considering CLP Criteria for aquatic classification of the substance, it is concluded that N,N-dimethyl-p-toluidine does exhibit toxicity to (green algae, Pseudokirchnerella subcapitata, Chlorella pyrenoidosa) in aquatic chronic category 3

Toxicity to microorganism:

Based on the various studies available with Klimish rating 2 and 4 for the target substance CAS NO 99-97-8 and read across substances and based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. The results is summarized as follows

 

Sr.No

Endpoint

Effect values

Basis for effects

Duration

Species

Remarks

1

IGC50

80.53

mg/l

growth inhibition

48 hrs

Tetrahymena pyriformis

 

Predicted data for target chemical

2

EC50

 

 

 

161.2

 mg/l

 

 

 

growth inhibition

24 hrs

Tetrahymena pyriformis

 

Predicted data for target chemical

3

EC50

 

 

 

42.86

 mg/l

 

 

 

growth inhibition

48 hrs

Tetrahymena pyriformis

 

Predicted data for target chemical

4

IGC50

32.6

mg/l

growth inhibition

48 hrs

Tetrahymena pyriformis

 

Data from publication for CAS no 91-66-7

5

EC50

 

13.6 mg/L

 

reduction in light emission

30 min

Photobacterium phosphoreum

Data from publication for CAS no 121-69-7

 

By applying weight of evidence approach to the studies summarized in the above table it can be observed that EC50 value is expected to be in the range of 13.6 to 161.2 mg/l based on the growth inhibition effect for various duration starting from 30 mins till 48 hours.