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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
3 (not reliable)
Justification for type of information:
No data
Cross-reference
Reason / purpose for cross-reference:
reference to other study
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline available
Principles of method if other than guideline:
The test guideline is not available in source test.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test guideline is not available in source test.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route)
Challenge: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route)
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route)
Challenge: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route)
No. of animals per dose:
10
Details on study design:
No additional data
Challenge controls:
No data
Positive control substance(s):
no
Positive control results:
No data
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
Hexamethylene Diamine (HMD) at 2% and 1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Hexamethylene Diamine (HMD) at 2% and 1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
72
Group:
positive control
Dose level:
Hexamethylene Diamine (HMD) at 2% and 1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Interpretation of results:
GHS criteria not met

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1948
Report date:
1948

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The aim of this study was to determine the sensitisation of Hexamethylene Diamine (HMD) with skin tests on Guinea Pigs. Two skin tests were performed. Firstly, a contact test with undiluted compound was performed, and secondly, a contact and sensitisation test was performed with a 2% aqueous solution of HMD, applied on skin with an initial patch and then with a final patch. For the contact and sensitisation test, a final injection was given to each rat after the customary ten-day rest period.
For all tests effects of HMD were analysed.
GLP compliance:
no
Type of study:
other: study performed before GLP statement

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexamethylenediamine
EC Number:
204-679-6
EC Name:
Hexamethylenediamine
Cas Number:
124-09-4
Molecular formula:
C6H16N2
IUPAC Name:
hexane-1,6-diamine
Details on test material:
- Name of test material (as cited in study report): Hexamethylene diamine
- Physical state: No data
- Analytical purity: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
Hexamethylene Diamine (HMD) at 2% and 1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Results
Remarks on result:
no indication of skin sensitisation based on QSAR/QSPR prediction

Applicant's summary and conclusion

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