2-({1-[(2-methoxyphenyl)amino]-1,3-dioxobutan-2-yl}diazenyl)benzoic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study done according to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

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)

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid

EC Number:

683-287-0

Cas Number:

877670-90-1

Molecular formula:

C18H17N3O5

IUPAC Name:

2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid

Details on test material:

Batch 939-76

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

other: N,N-Dimethylformamide (DMF).

Concentration:

2.5, 1, 0.5% W/V in DMF

No. of animals per dose:

4

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Test Group Name Negative control (solvent) DMF 1.0 Anthranilic Acid-AAOA, 2.5% 2.1 Anthranilic Acid-AAOA, 1.0% 1.5 Anthranilic Acid-AAOA, 0.5% 1.2

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Test Group Name Negative control (solvent) DMF 860.1 Anthranilic Acid-AAOA, 2.5% 1842.1 Anthranilic Acid-AAOA, 1.0% 1254.5 Anthranilic Acid-AAOA, 0.5% 1052.9

Any other information on results incl. tables

See Figure 1: Test Item Stimulation Index Values

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the conditions of the present assay Anthranilic Acid-AAOA tested up to the maximum feasible concentration (2.5 %) in an appropriate solvent was shown to have no sensitisation potential (non-sensitiser) in the Local Lymph Node Assay, because no SI value equal to or greater than the threshold value of 3.0 was observed.

Executive summary:

The aim of this study was to determine the skin sensitisation potential of Anthranilic Acid-AAOA following dermal exposure. The maximum concentration of test item in an appropriate solvent was established according to OECD guideline 429. The maximum available concentration based on solubility was 2.5 % (% w/v) in N,N-Dimethylformamide (DMF). A preliminary irritation/toxicity test was performed showing that the maximum concentration of test item of 2.5 % in DMF was acceptable. Sixteen female CBA/Ca mice were allocated to four groups of four animals: - three groups received test item at concentrations of 2.5 %, 1.0 % and 0.5 %, - the negative control group received the solvent (DMF). Each substance was applied on the external surface of each ear (25 ul/ear) of the animals for three consecutive days (Day 1, 2 and 3). There was no treatment on Day 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the obtained values were used to calculate stimulation indices (SI). No mortality or systemic clinical signs were observed during the study. No treatment related effects were observed on animal body weights in any treatment groups. No cutaneous reactions were observed at the treated site in any of the treated groups. No significant lymphoproliferative response (SI greater than or equal to 3) was observed with Anthranilic Acid-AAOA at the applied concentrations. The stimulation index values (SI) were 2.1, 1.5 and 1.2 at concentrations of 2.5 %, 1.0 % and 0.5 %, respectively. The stimulation index values corresponded to the conventional biological dose response. The result of the latest reliability check (performed within an interval of no longer than six months, Study code: 08/654-037E) was used to demonstrate the appropriate performance of the assay in accordance with the OECD guideline 429. The positive control substance alpha-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle. A significant lymphoproliferative response (SI greater than or equal to 3) was noted for HCA with stimulation index value of 7.1, the result confirms the validity of the LLNA in this laboratory. Conclusion: Under the conditions of the present assay Anthranilic Acid-AAOA tested in an appropriate solvent up to the maximum feasible concentration (2.5 %) was shown to have no sensitisation potential (non-sensitiser) in the Local Lymph Node Assay, because no SI value equal to or greater than the threshold value of 3.0 was observed.