Reaction product of M-Tolylidendiisocyanat (26471-62-5), p-Toluidine (106-49-0), and n-Octylamine (111-86-4)

Additional information on environmental fate and behaviour

Administrative data

Endpoint:

additional information on environmental fate and behaviour

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Non-GLP, non-guideline study following sound scientific principles. This is a non-standard, proprietary study specifically designed and conducted in order to provide supporting evidence to the testing program. Acceptable with restrictions.

Justification for type of information:

Polyurea grease thickeners are all reaction products of isocyanate and amines. For further details on the read across approach and bioaccessibility strategy, see attachments in Section 13 of IUCLID.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2018

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The main purpose of this study is to provide data on the leachability of the polyurea thickener base grease samples in demineralized water.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of aniline and m-tolylidene diisocyanate

EC Number:

901-891-7

Molecular formula:

C21H20N4O2

IUPAC Name:

Reaction mass of aniline and m-tolylidene diisocyanate

Test material form:

solid

Specific details on test material used for the study:

- Concentrations: The substance was tested at 20 % grease thickener concentration in medicinal/pharmaceutical grade white oil.
- Analysis: The WAF leachate concentration of the polyurea were determined using the UPLC-UV analytical method.

Results and discussion

Any other information on results incl. tables

The concentrations detected in the leaching study are shown in Table 1. The results are similar between replicates, and pre-and post-centrifugation, and confirm WAF leachate concentrations are above the LOD and LOQ for the analytical method. The test substance was also detected in the SPME analysis. A mean concentration of 0.0123 mg/L was determined to have leached into the WAF.

Table 1        The measured concentrations in the duplicate vessels in the leaching studies

Sample	Concentration in WAF (mg/L)
A054 base grease WAF 1	0.014
A054 base grease WAF 2	0.0131
A054 base grease WAF 1 (centrifuged)	0.0117
A054 base grease WAF 2 (centrifuged)	0.0116
Mean	0.0123

 

Applicant's summary and conclusion

Conclusions:

The results from the test substance analysis were between 0.0131 to 0.0140 mg/L for the non-centrifuged samples and 0.0116 to 0.0117 mg/L for the centrifuged samples. The results were slightly higher than the solubility results, concluding that the substance in base oil is bioaccessible.

Executive summary:

Leaching studies have been undertaken on thickeners in base oils to provide additional data on the grease thickener testing strategy. The approach for the polyurea thickeners was to use a solid-phase microextraction (SPME) method combined with gas chromatography (GC) to assess the bioaccessibility of the water accommodated fractions (WAFs) of polyurea base grease. The analysis confirmed that the test substance is bioaccessible as the results were between 0.0131 to 0.0140 mg/L for the non-centrifuged samples and 0.0116 to 0.0117 mg/L for the centrifuged samples, which were slightly higher than the solubility results.