5'-chloro-2'-methoxyacetoacetanilide

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:

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

Reason / purpose for cross-reference:

reference to same study

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)

Species:

mouse

Strain:

CBA

Sex:

female

Vehicle:

dimethyl sulphoxide

Concentration:

10, 25, 50 % (in DMSO)

No. of animals per dose:

4 females

Parameter:

SI

Remarks on result:

other: See table below

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See table below

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 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
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.

Justification for selection of skin sensitisation endpoint:
Study documented and performed according to GLP standards and in compliance with OECD Guideline 429.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).