Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

from 21st May 2003 to 26th May 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

study performed on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.

Justification for type of information:

The read across justification is detailed in section 13.

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

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Version / remarks:

2002

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test material form:

solid: particulate/powder

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

other: ethanol/water (50/50, v/v)

Concentration:

0, 2.5, 5 and 10%

No. of animals per dose:

Sixteen females (three treated group and 1 negative control group)

Details on study design:

The animals were allocated to four groups of four animals each:
- three treated groups receiving the test item at the concentration of 2.5, 5 or 10%,
- one negative control group of four animals receiving the vehicle (mixtiue ethanol/water (50/50)).

Positive control substance(s):

not specified

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.1

Test group / Remarks:

Conc. 2.5 and 5 %

Results 2

Parameter:

SI

Value:

1.59

Test group / Remarks:

Conc. 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 of the vehicle control group.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) No 1272/2008

Conclusions:

The test item was found not to be skin sensitizer under experimental conditions.

Executive summary:

In order to evaluate the skin allergenic potential of the test item, a Local Lymph Node Assay (LLNA) was performed according to the OECD Guideline No. 429 (2002). Three dose levels from 2.5 to 100 % of test item in the vehicle (ethanol/water (50/50, v/v)) and the vehicle alone as negative control were administered to sixteen female CBA/J allocated to four groups of four animals each.

The calculated Stimulation Index were 1.1 at the two low doses and 1.59 at the high dose. Thus, the test item should not be considered as a skin sensitizer under the experimental conditions and according to the followed OECD Guideline No. 429.