Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate

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 26 August 2009 to 04 November 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

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:

other: CBA/J@Rj

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier, le Genest-St-Isle, France
- Age at study initiation: 10 weeks
- Weight at study initiation: 21.6-22.6 g
- Housing: Individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 22 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr) 15-20:
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09 September 2009 To: 15 September 2009

Vehicle:

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

Concentration:

10, 25 and 50%

No. of animals per dose:

4

Positive control substance(s):

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

Positive control results:

HCA: 6633 DPM; S.I.: 9.4

Parameter:

other: Desintegration per minute

Value:

1 167

Test group / Remarks:

DV-SOLV 1059 10% in AOO

Parameter:

other: Desintegration per minute

Value:

1 094

Test group / Remarks:

DV-SOLV 1059 25% in AOO

Parameter:

SI

Value:

1.7

Test group / Remarks:

DV-SOLV 1059 10% in AOO

Parameter:

SI

Value:

1.2

Test group / Remarks:

DV-SOLV 1059 50% in AOO

Parameter:

SI

Value:

1.6

Test group / Remarks:

DV-SOLV 1059 25 % in AOO

Parameter:

other: Desintegration per minute

Value:

833

Test group / Remarks:

DV-SOLV 1059 50% in AOO

Remarks on result:

other:

 

Test Group	Measured DPM/group	DPM-BG	Number of nodes	DPN	S.I.
BG	41		-
NC	746	705	8	88.1	1.0
10% in AOO	1208	1167	8	145.9	1.7
25% in AOO	1135	1094	8	136.8	1.6
50% in AOO	874	833	8	104.1	1.2
PC	6633	6592	8	824.0	9.4

 

 

BG = Background (1 ml 5% trichloroacetic acid)

NC = Negative Control Group (acetone/olive oil 4:1)

PC = Positive Control Group (25%HCA in AOO)

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test item was not a skin sensitizer in this assay under the described conditions.

Executive summary:

The test item DV-SOLV 1059 was assessed in this study for its contact allergenic potential.

A local lymph node assay was performed in CBA/J@Rj mice using test item concentrations of 10, 25 and 50% in acetone:olive oil 4:1.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. No local signs of irritation of the ear skin were detected.

In this study Stimulation Indices (S.I.) of 1.7, 1.6 and 1.2 were determined with the test item at concentrations of 10, 25 and 50% in AOO, respectively. The validity of the assay was demonstrated from the positive control substanceHCA25% in AOO, with S.I. of 9.4. The test item was not a skin sensitizer in this assay under the described conditions.

DV-SOLV 1059 is not classified as a skin sensitizer according to the criteria of Annex VI Directive 67/548/EECand EU GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation:

On study of reliability 1 according to Klimisch cotation critera, is available for skin sensitization (Torok-Batho M., 2009) and was selected as a key study. In this study (OECD429), DV-SOLV 1059dissolved in acetone: olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed in CBA/J@Rj mice using test material concentrations of 10, 25 and 50%.The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. No local signs of irritation of the ear skin were detected. In this study Stimulation Indices (S.I.) of 1.7, 1.6 and 1.2 were determined with the test item at concentrations of 10, 25 and 50% in AOO, respectively. The validity of the assay was demonstrated from the positive control substance HCA 25% in AOO, with S.I. of 9.4. The test item was not a skin sensitizer in this assay under the described conditions.

DV-SOLV 1059 is not classified as a skin sensitizer according to the criteria of Annex VI Directive 67/548/EECand EU GHS.

Migrated from Short description of key information:
The name of the tested substance is DV-SOLV 1059.
The DV-SOLV 1059 is the previous name of the Rhodiasolv Polarclean. The specifications of the DV-SOLV 1059 are in line with the dossier and representative of the industrial product manufactured by Schirm.

DV-SOLV 1059 did not demonstrate a skin sensitization potential in a Local Lymph Node Assay.

Justification for selection of skin sensitisation endpoint:
only one study available (GLP and OECD guideline 429 compliant)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/EEC or EU regulation 1272/2008 (CLP) and given the absence of positive reactions in a LLNA, the test substance DV-SOLV 1059 is not classified as a skin sensitiser.