4,4'-methylenebis(cyclohexylamine)

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish life cycle toxicity

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Accepted calculation method

Principles of method if other than guideline:

Estimation of a chronic NOEC according to the acute to chronic ratio approach (ACR; ECETOC, 2003, Technical Report No. 91)

GLP compliance:

no

Test organisms (species):

other: freshwater fish

Water media type:

freshwater

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

> 1 mg/L

Basis for effect:

other: expected NOEC based on ACR approach

Acute/Chronic ratio approach:

Source	Description	ACR (90 %-ile)	expected NOEC (mg/L): LC50 (> 100 mg/L) / ACR
Table 40	all species (geometric mean)	71	> 1
Table 40	all fish (geometric mean)	57	> 1
Table 41	all species (individual species)	71.2	> 1
Table 41	all fish (individual species)	70.1	> 1
Table 42	mode of action (individual species): narcotic	11.5	(> 1)*
Table 44	fish (Pimephales promelas)	70	> 1
Table 45b	Pimephales promelas /organics	39	> 1

* not applicable for primary amines 

- short term toxicity test on fish LC50 (96 h) mg/L: > 100 mg/L (neutralised)

 

- conclusion: table 40 -45b: expected NOEC: > 1 mg/L; approach applicable

Validity criteria fulfilled:

yes

Conclusions:

The calculation based on acute fish toxicity study determines the NOEC for fish to be >1 mg/L .

Executive summary:

The substance does not have a potential to bioaccumulate nor is it considered as a PBT/vPvB substance. The results from short-term toxicity tests on fish, Daphnia and algae demonstrate that invertebrates are the most sensitive trophic level tested. Further, a reproduction test on Daphnia magna is available (read-across to the structurally similar substance DMDC, CAS 6864-37-5). The ACR approach for fish indicated that the long-term NOEC would be greater than 1 mg/L. Therefore, it can be concluded that results from a long-term test in fish would not reveal a greater hazard than already determined by the available data. Based on the estimated long-term toxicity values (ACR approach) and for reasons of animal welfare long-term aquatic toxicity testing on fish is not indicated. Moreover, the exposure levels estimated in all relevant scenarios do not exceed the appropriate PNEC so that the risk to the environment can be considered to be adequately controlled throughout the lifecycle of the substance.

Description of key information

There is no experimental data available.

An ACR approach for fish indicated that the long-term NOEC would be greater than 1 mg/L.

Additional information

There is no experimental data available.

The chemical safety assessment does not indicate a need to investigate further long-term toxicity on fish. The exposure levels estimated in all relevant scenarios do not exceed the appropriate PNEC, and the likelihood and severity of an event occurring due to the physicochemical properties of the substance in the aquatic environment are negligible. Furthermore, the substance does not have a potential to bioaccumulate. In addition, the ACR approach for fish indicated that the long-term NOEC would be greater than 1 mg/L. Therefore, it may be concluded that results from a long-term test in fish would not reveal a greater hazard than already determined by the available data. Therefore, and for reasons of animal welfare long-term aquatic toxicity testing on fish is not indicated.