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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes (incl. certificate)
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
pH value: 12.2
Specific details on test material used for the study:
Batch identification: C520/094/2017
CAS No.: mixture of 7003-32-9 + 6321-23-9
Purity: Cyclohexylamine-methyl: 99.763 area-%

In chemico test system

Details on study design:
Synthetic peptides:
Cysteine- (C-) containing peptide: Ac-RFAACAA-COOH (MW=751.9 g/mol)
Lysine- (K-) containing peptide: Ac-RFAAKAA-COOH (MW=776.2 g/mol)

The peptides are custom material (Supplier: GenScript, Piscataway, NJ, USA and JPT Peptide Technologies GmbH, Berlin, Germany)

Results and discussion

Positive control results:
The positive control caused depletion of both peptides comparable to historic data

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: peptide depletion
Remarks:
cystein
Value:
-0.12
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Parameter:
other: peptide depletion
Remarks:
lysine
Value:
-0.48
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Peptide depletion [%]

 cystein

sample 1

sample 2

sample 3

mean

SD

NC: ACN

- 0.24

0.30

- 0.06

0.00

0.28

Test substance

- 0.67

- 0.14

0.45

- 0.12

0.56

PC: EGDMA in ACN

60.04

63.78

64.93

62.92

2.55

lysine

sample 1

sample 2

sample 3

mean

SD

NC: ACN

- 0.71

0.04

0.31

0.00

0.62

Test substance

- 0.33

- 0.78

- 0.33

- 0.48

0.26

PC: EGDMA in ACN

9.67

10.22

10.84

10.25

0.59

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean C-peptide depletion, caused by the test substance was determined to be -0.12%.
The mean K-peptide depletion, caused by the test substance was determined to be -0.46%.
Executive summary:

Based on the observed results it was concluded that Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen, deaminated shows minimal or no chemical reactivity in the DPRA under the test conditions chosen.