Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2002
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Acid Navy RN-2682
IUPAC Name:
Acid Navy RN-2682
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
temperature: 22 ± 3 °C
relative humidity: 30 - 82 %
artificial light: 6 a.m. to 6 p.m.

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
5, 10, 25 %
No. of animals per dose:
4
Details on study design:
Application volume: 25 µl on the entire dorsal surface of each ear lobe once daily for 3 consecutive days.
5 days after the first topical application, all mice were administered with 250 µl of 78.8 µCi/ml 3HTdR by i.v. injections via a tail vein.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.2
Test group / Remarks:
5 %
Parameter:
SI
Value:
1.35
Test group / Remarks:
10 %
Parameter:
SI
Value:
1.96
Test group / Remarks:
25 %
Cellular proliferation data / Observations:
The EC3 value could not be calculated, since all SI´s are below 3.

Viability / mortality: no deaths occurred during the study period.

Clinical signs: no symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.

Body weights: the body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
Not sensitising.

Categories Display