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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Description of key information

The substance is acutely harmful to fish.

Key value for chemical safety assessment

Additional information

QSAR-disclaimer

In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.

According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.

For the assessment of modified Isophoronediamine (CAS 93940-97-7) (Q)SAR results were used for toxicity to aquatic organisms.The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.

 

Therefore, and for reasons of animal welfare further experimental studies on aquatic toxicity are not provided.

Assessment:

Experimental data on the acute toxicity of modified Isophoronediamine (CAS 93940-97-7) towards fish are not available.

However, several (Q)SAR models were used in order to assess the acute toxicity to fish. The table below lists the applied (Q)SAR models, the estimated acute fish toxicity values (96 -h LC50) and basic information on the applicability domain (AD). Detailed information on the model’s results and the AD are given in the endpoint study records of IUCLID Chapter 6.1.1. The selected models comply with the OECD principles for (Q)SAR models.

 

Summary of relevant information on short term toxicity to fish: Predicted 96 -h LC50 values for applied QSAR models (AD = Applicability Domain)

Model

96 -h LC50 [mg/L]

In AD

Restraints

ECOSAR v1.11 Aliphatic Amines

53.1

yes

-

Trend analysis 3 (Toolbox

v3.3.0.152)

69.9

yes

-

Trend analysis 2 (Toolbox

v3.3.0.152)

72.8

yes

-

Trend analysis 1 (Toolbox

v3.3.0.152)

97.7

yes

-

Toolbox v4.2 (Prediction for single chemical)

141

yes

-

Conclusion

All QSAR models applied calculated 96-h LC50 values between >10 mg/L and <= 141 mg/L; the substance was within the applicability domain of all models The lowest calculated value of 53.1 mg/L is considered for the assessment (worst-case approach). Based on the calculated data, the substance is concluded to be acutely harmful to fish.