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:
2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
No data

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
1; 2,5 and 5%
No. of animals per dose:
4 females per group
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
ca. 1.48
Test group / Remarks:
1% : 1,48
Parameter:
SI
Value:
1.46
Test group / Remarks:
2,5%: 1.46
Parameter:
SI
Value:
2.16
Test group / Remarks:
5 %: 2.16
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Per group: Vehicle: 309.20 1%: 458.7 2,5%: 450.02 5%: 667.02 Per node: Vehicle: 38.65 1%: 57.34 2,5%: 56.25 5%: 83.38

Any other information on results incl. tables

No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.

Concerning the lymphoproliferative response, no positive lymphoproliferative response (SI > 3) and no dose-response relationship were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to EEC (European Economie Community) and CLP classification the tested substance Acid yellow 23 is not a skin sensitizer.
Executive summary:

The purpose of this skin sensitization study was to assess the allergenic potential of Acid Yellow 23 when administered to the skin of CBA mice following OECD 429, murine local lymph assay.

Based on the results, the tested item should not be considered as skin sensitizer under defined experimental conditions in the two vehicles tested.