5'-chloro-3-hydroxy-2'-methyl-2-naphthanilide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: performed in accordance with OECD and GLP guidelines

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)

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:

5'-chloro-3-hydroxy-2'-methyl-2-naphthanilide

EC Number:

205-207-1

EC Name:

5'-chloro-3-hydroxy-2'-methyl-2-naphthanilide

Cas Number:

135-63-7

Molecular formula:

C18H14ClNO2

IUPAC Name:

N-(5-chloro-2-methylphenyl)-3-hydroxy-2-naphthamide

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
-strain: CBA/CaOlaHsd
- Source: Harlan Netherlands
- Age at study initiation: 6-7 weeks (beginning of acclimatization)
- Weight at study initiation: 16.5 g to 21.4 g
- Housing: single caging, Makrolon Type I, with wire mesh top, granulated soft wood bedding
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 78 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

0, 0.1, 0.2, 0.4, 1.0, 5.0% (w/v)

No. of animals per dose:

4 animals per treatment group, 4 animals in the control group

Positive control substance(s):

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

Results and discussion

Positive control results:

EC3: 18.2% (w/v)

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: The S.I. were 2.00, 2.51, 3.71, 3.70 and 4.22 for concentrations of 0.1, 0.2, 0.4, 1.0 and 5.0% in DMSO (w/v) respectively.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Results expressed as mean per group Group -- DPM per lymph node -- SI Vehicle -- 453.6 0.1% -- 1272.0 -- 2.00 0.2% -- 1137.9 -- 2.51 0.4% -- 1680.9 -- 3.71 1.0% -- 1676.4 -- 3.70 5.0% -- 1913.2 -- 4.22

Any other information on results incl. tables

No deaths or abnormal body weight development were observed during the study period.The animals did not show any clinical signs of toxicity after the first and second application. After the third application the highest dose (5 %) induced slight redness of the of the ear skin of all 4 animals of the group. No systemic findings were observed during the study period.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was found to be a skin sensitiser in the LLNA when tested at 0.1, 0.2, 0.4, 1.0 and 5.0% in DMSO (w/v).
An EC3 value is calculated to be 0.3% (w/v).