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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

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

Constituent 1
Chemical structure
Reference substance name:
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate
EC Number:
700-204-6
Cas Number:
1174627-68-9
Molecular formula:
C9H17NO3
IUPAC Name:
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): DV-SOLV 1059

In vivo test system

Test animals

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

Study design: in vivo (LLNA)

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)

Results and discussion

Positive control results:
HCA: 6633 DPM; S.I.: 9.4

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: S.I.: 1.7, 1.6 & 1.2 for 10, 25 5 50 % respectively
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: DPM: 1208, 1135, 874 for 10, 25 & 50% respectively

Any other information on results incl. tables

 

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)

Applicant's summary and conclusion

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.

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