Registration Dossier

Administrative data

Description of key information

Not sensitizing

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation, other
Remarks:
QSAR estimation
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: QSAR model developed for dyes
Justification for type of information:
QSAR predictive models developed for dyes.
Qualifier:
no guideline required
Principles of method if other than guideline:
QSAR estimation
Justification for non-LLNA method:
-
Parameter:
other: skin sensitization
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Not skin sensitizing
Executive summary:

Based on QSAR estimation, no concern for skin sensitization.

Endpoint:
skin sensitisation, other
Remarks:
in vivo LLNA
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Colipa report C174
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA:J
Sex:
female
Vehicle:
other: DMSO, water/acetone (1:1) mixed with olive oil (4:1)
Concentration:
0.5, 1, 2 and 4 %
No. of animals per dose:
5 female
Details on study design:
25 μl of 0 (vehicle only), 0.5, 1, 2 and 4 % (exceeding the maximal solubility in both vehicles used) of the tested substance in either DMSO or a mixture of aqua/acetone (1:1) with olive oil (4:1) were applied on three consecutive days to the surface of the ear of 5 female CBA/J mice per group.
After application, the ears were dried for about 5 minutes by means of a hair dryer.
Positive control substance(s):
other: p-phenylenediamine at 1 % in DMSO
Positive control results:
The positive control (PPD, 1 % in DMSO) caused an increase in the stimulation index by a factor of 7.8.
Parameter:
SI
Value:
0.6
Test group / Remarks:
0.5 % dose in DMSO
Parameter:
SI
Value:
0.7
Test group / Remarks:
1 % dose in DMSO
Parameter:
SI
Value:
0.9
Test group / Remarks:
2 and 4 % doses in DMSO
Parameter:
SI
Value:
1.2
Test group / Remarks:
0.5 % dose in water/acetone/olive oil
Parameter:
SI
Value:
1
Test group / Remarks:
1 % in water/acetone/olive oil
Parameter:
SI
Value:
0.9
Test group / Remarks:
2 and 4 %doses in water/acetone/olive oil
Cellular proliferation data / Observations:
No relevant increase in the mean stimulation indices was observed
Interpretation of results:
GHS criteria not met
Conclusions:
Not skin sensitizer
Executive summary:

Under the test conditions no indications was found to considered the tested substance as a skin sensitizer.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Toxnet and Jefca evaluation
Qualifier:
equivalent or similar to
Guideline:
other: Draize Shelansky test
Version / remarks:
Comparable to the original Draize HRIPT.
Deviations:
not specified
Principles of method if other than guideline:
The test employs 15 consecutive induction patches to the same site and if erythema and/or edema develops during induction the following patch should be moved to an adjacent untreated area. 2-3 weeks after the last induction a challenge patch is applied for 48 hours and scored. The induction patch responses are also noted and interpreted as evidence of cumulative irritation.
GLP compliance:
no
Type of study:
other: Draize - Shelansky
Justification for non-LLNA method:
Accepted method for assessment.
Species:
other: human
Positive control results:
No data
Hours after challenge:
72
Group:
test group
Dose level:
25 % aqueous solution
No. with + reactions:
0
Total no. in group:
200
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Not skin sensitizer
Executive summary:

None of the subjects exhibited compound induced sensitization.

Endpoint:
skin sensitisation, other
Remarks:
in vivo
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Toxnet reference - Jefca Evaluation
Qualifier:
no guideline available
Principles of method if other than guideline:
Human data on skin application
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Valid test on 200 humans
Species:
other: human
Sex:
not specified
Hours after challenge:
72
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
200
Clinical observations:
None of the subjects exhibited compound induced sensitization
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Not skin sensitizer
Executive summary:

None of the subjects exhibited compound induced sensitization

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available results both on animals and on human, the tested substance could be considered as not skin sensitizing.

This was confirmed also by the QSAR estimation specifically developed for dyes which predict the substance as not sensitizing.