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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Based on read-across to the two structurally similar molecules (2,4-dinitrotoluene and 2,6-dichloro-4-nitroaniline) and a Toxtree analysis of the compound which identified no skin sensitisation alerts.

 

It is assumed the compound N,N,N-trimethyl-nitroanilinium chloride is not a skin sensitizer, and therefore has no skin sensitization classification under CLP (1272/2008).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Read-across study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
See attached for read-across supporting information.
Qualifier:
no guideline required
Principles of method if other than guideline:
Read across to 2,6-dichloro-4-nitroaniline JMPR evaluation
GLP compliance:
not specified
Remarks:
Data from collection/ handbook, no informaiton on completion date or compliace is available.
Type of study:
other: Read across to 2,6-dichloro-4-nitroaniline JMPR evaluation
Specific details on test material used for the study:
Test material specifics not available, read-across from collection of data.
Species:
other: Not specified
Strain:
not specified
Sex:
not specified
Key result
Reading:
other: Not Specified, final result only available
Group:
other: Not Specified, final result only available
Clinical observations:
None specified, final result only available
Remarks on result:
positive indication of skin sensitisation
Remarks:
Not sensitising (JMPR evaluation) Method of evaluation (in vivo/ vitro/ chemico) not specified in summary report

Not sensitising (JMPR evaluation) Method of evaluation (in vivo/ vitro/ chemico) not specified in summary report.

Interpretation of results:
GHS criteria not met
Conclusions:
The compound 2,6-dichloro-4-nitroaniline was not found to be a skin sensitizer, and therefore has no skin sensitization classification under CLP (1272/2008)
Executive summary:

The compound 2,6-dichloro-4-nitroaniline was not found to be a skin sensitizer, and therefore has no skin sensitization classification under CLP (1272/2008)

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975 - from collection of data, only completeion available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
See attached for read-across supporting information.
Qualifier:
no guideline available
Principles of method if other than guideline:
Read across to 2,4-dinitrotoluene EU RAR assessment.
Prior to Guidleine: Read across to 2,4-dinitrotoluene EU RAR assessment
GLP compliance:
not specified
Remarks:
Data from collection/ handbook, no informaiton on completion date or compliace is available.
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Read across to 2,4-dinitrotoluene EU RAR assessment
Specific details on test material used for the study:
(2,4-DNT purity = 98%; 2,6-DNT impurity = 2%)
Species:
guinea pig
Strain:
not specified
Remarks:
Read-across to EU RAR assessment, study details not included
Sex:
not specified
Details on test animals and environmental conditions:
Dermal sensitivity was noted in none of ten guinea pigs following 2,4-DNT treatment (2,4-
DNT purity = 98%; 2,6-DNT impurity = 2%) by means of Guinea-Pig Maximisation Test (No
further details on method and test results are available)
Key result
Reading:
other: Final result from EU RAR read-across
Group:
other: Final result from EU RAR read-across
Dose level:
Final result from EU RAR read-across
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No sensitivity was noted
Remarks on result:
no indication of skin sensitisation

Dermal sensitivity was not observed in guinea pigs following 2,4-DNT treatment by means of

Guinea-Pig Maximisation Test. Thus, 2,4-DNT is not classified as sensitising substance in

accordance with the EU criteria.

Interpretation of results:
GHS criteria not met
Conclusions:
Dermal sensitivity was not observed in guinea pigs following 2,4-DNT treatment by means ofGuinea-Pig Maximisation Test.
The compound 2,4-dinitrotoluene was not found to be a skin sensitizer, and therefore has no skin sensitization classification under CLP (1272/2008)
Executive summary:

Dermal sensitivity was not observed in guinea pigs following 2,4-DNT treatment by means ofGuinea-Pig Maximisation Test.

The compound 2,4-dinitrotoluene was not found to be a skin sensitizer, and therefore has no skin sensitization classification under CLP (1272/2008)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Not required based on tonnage

Justification for classification or non-classification

There is sufficient evidence from the two structurally similar molecules (2,4-dinitrotoluene and 2,6-dichloro-4-nitroaniline) and a Toxtree analysis of the compound which identified no skin sensitisation alerts to show the compound N,N,N-trimethyl-nitroanilinium chloride is not a skin sensitizer, and therefore has no skin sensitization classification under CLP (1272/2008).