[No public or meaningful name is available]

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2007-11-21 till 2007-12-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-conform study under GLP without deviations.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

A preliminary test was performed first to detect the highest application solution. The maximum technically applicable concentration was found to be 50%. Based on the results of this preliminary test the test item was assayed at three concentrations: 12,5%, 25%, 50% (w/v).

No. of animals per dose:

5 mice per test group; 3 test groups (3 different concentrations) and 1 Negative Control Group (vehicle) were tested.

Positive control substance(s):

other: p-Phenylenediamine

Positive control results:

The stimulation index observed in the historical positive control group of the BSL study no. 073846 with 1% p-Phenylendiamine was 8.1.

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Table 3: Radioactive determination of the test substance groups. If not noted individually, results include both lymph nodes of an animal.

Summary Results:

The stimulation index at a conc. of 12.5 % was 0.7,

The stimulation index at a conc. of

25 % was 0.9

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The EC3 value (derived by linear interpolation) for the test substance could not be stated, as all measure points were below the stimulation index of three. Considering the reported data of this sensitization test it can be stated that the test item causes no reactions identified as sensitization, as the stimulation index was below 3.0 for each concentration tested.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a Local Lymph Node Assay ( OECD 429 adopted: 24th April 2002) with mice none of the three tested concentrations of the test item reached the stimulation index of 3.

All animals survived throughout the test period without showing any clinical sign.

Migrated from Short description of key information:
The substance is not sensitising. The stimulation index < 3.0 for each concentration tested.

Justification for selection of skin sensitisation endpoint:
only existing but sufficient study

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Migrated from Short description of key information:
substance is not sensitising.

Justification for classification or non-classification

According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding sensitisation.