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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline 429 in compliance to GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test item : 2-[(4-N,N-bis-(2'-hydroxyethyl)amino-2-nitrophenyl)amino]ethanol
EC number : 252-410-3
Batch number : 114B5
Content : 98.7%

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
25uL of 0.5, 1.0, 2.5, 5 and 10% in dimethylformamide.
No. of animals per dose:
4 females per dose
Details on study design:
Range Finding Test : No information available

Main Study
In two independent experients, 25uL HC Blue No2 in dimethylformamide was applied to the dorsal surface of both ears at the followinh concentrations : 0.5%, 1.0%, 2.5%, 5.0%, 10.0%. A positive control group received 25% alpha-hexylcinnamicaldehyde (HCA) in dimethylformamide and the negative control the vehicle alone.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Positive control induced a positive response. The stimulation indices were 9.97 and 5.70 at the concentration of 25%.

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
In each experiment, during the induction phase, the test item, vehicle or positive control was applied over the ears (25uL per ear) for 3 conecutive days. After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated thymidine (day 6). The obtained values were used to calculate stimulation indices (SI). In the first experiment, an increase in stimulation index was observed at 5% only. In the second experiment, a dose related increase in the stimulation index was noted at concentrations between 1 and 10%, but the threshold positove value of 3 was not reached at any of the tested concentrations.

Any other information on results incl. tables

Experiment 1

 Treatment Concentration (%)  Signs of Local Irritation  Stimulation Index (SI) 
B37   0.5  no  1.37
B37   1  no  1.03
B37  2.5  no  1.30
 B37  5  no  3.92
 B37  10  no  1.55
 HCA  25  -  9.97

Experiment 2

 Treatment  Concentration (%) Signs of Local Irritation  Stimulation Index (SI) 
 B37  0.5  no  1.60
 B37  1.0  no  0.90
 B37  2.5  no  1.35
 B37  5  no  1.50
 B37  10  no  2.01
 HCA  25  -  5.70

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
While the data is equivocal, the test substance HC Blue No 2 is considered to have a skin sensitising potential.
Executive summary:

The potential of HC Blue no 2 to induce contact hypersensitivity was examined using the local lymph node assay (OECD guideline 429). Groups of 4 female mice in each were treated with 0.5%, 1%, 2.5%, 5% and 10% of the test substance in vehicle (dimethylformamide) for 3 daily treatments. After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated methyl thymidine (day 6). While the data is equivocal, the test substance HC Blue No 2 is considered to have a skin sensitising potential.