Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 3 to 8, 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
Local
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
1, 2.5, 5 %
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.09
Test group / Remarks:
1 %
Parameter:
SI
Value:
0.83
Test group / Remarks:
2.5 %
Parameter:
SI
Value:
0.53
Test group / Remarks:
5 %
Cellular proliferation data / Observations:
Viability = 100 × viable cells / (viable cells + dead cells)

Cellularity index = amount of cells (× 10^6 cells) in treated group / amount of cells (× 10^6 cells) in vehicle group

Stimulation index = dpm of treated group / dpm of control group
dpm = disintegrations per minute

Any other information on results incl. tables

No clinical signs and no mortality were observed during the study.

A red coloration of the ears, which could have sometimes masked a very slight erythema (grade 1), was noted on day 6 in all animals of the treated groups. No increase in ear thickness was noted.

Concerning the lymphoproliferative response, the incorporation of tritiated methyl thymidine in the treated groups was similar to that of the vehicle control group.

group cell count viability % amount of cells (× 10^6 cells) cellularity index number of nodes per group dpm per group dpm per node stimulation index (SI)

increase in ear tickness

(% between day 1 and 6)

viable dead
0 (control) 53 7 88.33 2.65 - 8 1733.18 216.65 - 0.00
1 % 128 5 96.24 6.40 2.42 8 1886.94 235.87 1.09 0.00
2.5 % 178 5 97.27 8.90 3.36 8 1436.68 179.59 0.83 -0.89
5 % 90 3 96.77 4.50 1.70 8 924.62 115.58 0.53 -1.92

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not skin sensitising.
Executive summary:

Method

LLNA method; no guideline reported. Groups of 4 female mice were treated with test substance using propylene glycole as vehicle. Tested concentrations were: 0 % (control), 1, 2.5 and 5 %.

Results

No clinical signs and no mortality were observed. Due to a red colouration of the ears, possible presence of a slight erythema was not visible. No increase in ear thickness was noted. Lymphoproliferative response was similar in treated and control groups. Stimulation index was below 3, thus indicating no sensitisng potential.