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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The most sensitive organisms regarding acute exposure to 4,4'-diamino-3,3',5,5'-tetramethyldicyclohexylmethan (CAS 65962-45-0) are algae (72 -h ErC50 = 5.0 mg/L, BASF SE, 2013). The lowest chronic effect value was determined in an algae study (72 -h ErC10 = 1.55 mg/L; BASF SE, 2013).

 

Short-term toxicity to fish:

Acutely harmful to fish.

No experimental data are available for 4,4'-diamino-3,3',5,5'-tetramethyldicyclohexylmethan (CAS 65962-45-0). Therefore a read-across approach to two structurally similar substances was performed.

The key study was performed on 2,2'-dimethyl-4,4'-methylenebis(cyclohexylamin) (CAS 6864-37-5) according to OECD 203 (NITE 2002) with Oryzias latipes. The 96-LC50 was determined to be 22.4 mg/L, the NOEC was 16 mg/L and the LC100 was 30 mg/L. The result is supported by a static-test study on CAS 6864-37-5 according to German industrial standard (DIN) 38412/15 (BASF 1988) performed with Leuciscus idus as test species. A 96-h LC50 of 31.6 mg/l was determined for non-neutralized samples (expressed as geometrical mean). The NOEC was determined to be 21.5 mg/l and the LC100 46.4 mg/l. Because DMD changes the pH in water, a neutralized sample with the highest test concentration (100 mg/l) was tested in addition. For this neutralized sample a diminution of the toxic effects was observed. 

An additional supporting study is a test performed on 4,4'-methylenebis-cyclohexanamine (CAS 1761-71-3) also performed according to German Industrial Standard DIN 38412, Part 15 using Leuciscus idus as test species (BASF AG, 1988; report no. 10F0562/875273).

The 96-h LC50 of 68.1 mg/L was determined for non-neutralised samples. A neutralised sample lead to a significant reduction of the mortality (96-h LC50 > 100 mg/L).

 

Long-term toxicity to fish:

No data available.

In Annex IX of Regulation (EC) No. 1907/2006, it is laid down that long-term toxicity to fish shall be proposed by the registrant of the chemical assessment indicates the need to investigate further the effects on fish.

According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB.

The hazard assessment of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane shows that the substance is not a PBT nor a vPvB substance. The results from short-term toxicity tests on fish, Daphnia and algae demonstrate that invertebrates are the most sensitive trophic level tested. 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, a chronic test on fish is not provided.

 

Short-term toxicity to aquatic invertebrates:

Acutely toxic to aquatic invertebrates.

The key study (GLP-guideline study according to OECD 202) determined a 48 -h EC50 of 8.95 mg/L. The nominal concentrations were analytically verified and all validity criteria were met in the test. Based on this data, the substance is acutely toxic to aquatic invertebrates.

 

Long-term toxicity to aquatic invertebrates:

Chronically not toxic to aquatic invertebrates.

No experimental data is available for 3,3’,5,5’-tetramethyl-4,4’-diaminodicyclohexylmethane (CAS 65962 -45 -0). Using a read-across approach to the structurally similar substance 2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine) (CAS 6864 -37 -5), data for a study following OECD 211 using Daphnia magna as the test species are available. The test performed by NITE (2003) was identified as the key study. The 21-d NOEC was determined to be 4.0 mg/L.

 

Toxicity to aquatic algae and plants:

Acutely toxic to aquatic algae.

The key study (GLP-guideline study according to OECD 201) determined a 72 -h ErC50 of 5.00 mg/L and a 72 -h ErC10 of 1.55 mg/L. The nominal concentrations were analytically verified and all validity criteria were met in the test. Based on this data, the substance is acutely toxic to freshwater algae.

 

Toxicity to microorganisms:

The inhibition of the degradation activity of activated sludge in a STP is not anticipated when introduced in appropriate low concentrations.

No experimental data are available for 4,4'-diamino-3,3',5,5'-tetramethyldicyclohexylmethane (CAS 65962-4-50). Therefore a read across approach to structurally similar substances was made to assess the toxicity to microorganisms. The selected substances were 2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine) (CAS 6864-37-5) and 4,4'-methylenebis(cyclohexylamine) (CAS 1761-71-3).

As key study a short-term respiration inhibition test on the analogous substance 4,4-methylenebis[2-methyl-]cyclohexanamine (CAS 6864-37-5) according to ISO 8192 with domestic activated sludge was identified (BASF 1990).The 30-min EC20 was determined to be 160 mg/L.

The following results support this finding:

- CAS 6864-37-5: BASF AG (1987). Report no. 9/0787/87. DIN 38412, part 8 (P. putida, growth inhibition): 17-h EC50 = 96 mg/L (nominal)

- CAS 1761-71-3: BASF AG (1987). Report no. 87/0792. DIN 38412, part 27 (draft; P. putida respiration inhibition): 30-min EC0 = 80 mg/L (nominal)

- CAS 1761-71-3: BASF AG (1986). Report no. 01.114/86. ISO 8192 (industrial act. sludge, respiration inhibition): 30-min EC20 > 1000 mg/L; 180-min EC20 < 100 mg/L (nominal)