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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
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:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
EC Number:
211-199-0
EC Name:
Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
Cas Number:
633-96-5
Molecular formula:
C16H12N2O4S.Na
IUPAC Name:
sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: mixture ethanol/water (50/50)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
0
Test group / Remarks:
Reading: 1st reading. . Hours after challenge: 28.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were observed..
Parameter:
SI
Value:
1.1
Test group / Remarks:
dose 2.5% and 5%
Parameter:
SI
Value:
1.59
Test group / Remarks:
dose 10%

Any other information on results incl. tables

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

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

disintegrations per minute (DPM)P
er Node:  Negative control: 43.43  2.5%: 47.90 5%: 47.88 10%: 69.20  

Per group:  Negative control: 347.47  2.5%: 383.17 5%: 383.04 10%: 553.59

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 Orange 7 is not a skin sensitizer.
Executive summary:

The purpose of this skin sensitization study was to assess the allergenic potential of Acid Orange 7 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.