5'-chloro-2'-methoxyacetoacetanilide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-10-27 to 2004-11-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study documented and performed according to GLP standards and in compliance with OECD Guideline 429: Skin sensitization: Local Lymph Node Assay

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable.

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-2'-methoxyacetoacetanilide

EC Number:

258-189-2

EC Name:

5'-chloro-2'-methoxyacetoacetanilide

Cas Number:

52793-11-0

Molecular formula:

C11H12ClNO3

IUPAC Name:

N-[5-chloro-2-(methoxyacetyl)phenyl]acetamide

Constituent 2

Reference substance name:

Acetoacetic-p-chloro-o-Anisidide

IUPAC Name:

Acetoacetic-p-chloro-o-Anisidide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Aggregate state at RT: Solid
Color: White
Storage: At RT, dry
Expiry date: September 01, 2005
Purity: > 99.9 % (w/w)

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

10, 25, 50 % (in DMSO)

No. of animals per dose:

4 females

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: See table below

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See table below

Any other information on results incl. tables

Results:

Vehicle: DMSO

Test item concentration % (w/v)	Group	Measurement DPM	DPM-BG a)	Number of Lymph Nodes	DPM per Lymph Node b)	S.I.
---	BG I	0.0	---	---	---	---
---	BG II	1.7	---	---	---	---
---	CG 1	5153.7	5152.9	8	644.1
10	TG 2	6436.3	6435.5	8	804.4	1.3
25	TG 3	7847.0	7846.2	8	980.8	1.5
50	TG 4	8094.6	8093.8	8	1011.7	1.6

BG = Background (1 ml 5% trichloroacetic acid) in duplicate

CG = Control Group

TG = Test Group

S.I. .= Stimulation Index

a) = The mean value was taken from the figures BG I and BG II

b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled 

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test item Acetoacetic-p-chloro-o-Anisidide was not a skin sensitiser under the described conditions.

Executive summary:

The LLNA study was documented and performed in year 2004 according to GLP standards and in compliance with OECD Guideline 429: Skin sensitization: Local Lymph Node Assay. As test system Mice, strain CBA/CaOlaHsd was used.

The animals did not show any clinical signs during the course of the study and no cases of mortality observed.

In this study stimulation indices (S.I.) of 1.3, 1.5, and 1.6 were determined with the test item at concentrations of 10 %, 25 %, and 50 % (w/v) in DMSO,

respectively. The test item Acetoacetic-p-chloro-o-Anisidide was not a skin sensitiser.