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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 15 December 2009 to 11 March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP K ft, Csaszar ut 135, Hungary
- Age at study initiation: approx. 14 weeks
- Weight at study initiation: 3706-4290 g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 34 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.0-20.6
- Humidity (%): 30-64
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 9 December 2009 To: 15 January 2010

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hours
Observation period:
73 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:
- % coverage: area approximately 6 cm2
- Type of wrap if used: gauze patch covered by plastic, truck encased in plastic and elastic tubing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water at body temperature
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Remarks on result:
other: no reaction
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Remarks on result:
other: no reaction
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Remarks on result:
other: no reaction
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no reaction
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Remarks on result:
other: no reaction
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Remarks on result:
other: no reaction
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Remarks on result:
other: no reaction
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no reaction
Irritant / corrosive response data:
no reactions
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DV-SOLV 1059 is not irritating to skin according to the criteria of this test.
Executive summary:

An acute skin irritation study was performed with DV-SOLV 1059 in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No.: 404, 2002). The test item was administered undiluted, at a single dose of 0.5 ml. Gauze was placed onto the hairless skin of the rabbit, test item was applied to the gauze, additional gauze was placed over the test item and an adhesive clear plastic patch applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control. After 4 hours, the remaining test item was removed with water at body temperature. To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily. There was no mortality or systemic clinical changes related to DV-SOLV 1059 administration. There was no effect of treatment on body weight. At observation one, 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals. As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hours observation. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00 and 0.00 respectively. According to Directive 2001/59/EC, DV-SOLV 1059 does not require classification as a skin irritant. According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, DV-SOLV 1059 does not require classification as a skin irritant.