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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Existing in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 June to 27 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD Guideline 404 (1992) and according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxypropyl 2-ethylhexanoate
EC Number:
261-499-0
EC Name:
2-hydroxypropyl 2-ethylhexanoate
Cas Number:
58921-10-1
Molecular formula:
C11H22O3
IUPAC Name:
2-hydroxypropyl 2-ethylhexanoate
Constituent 2
Chemical structure
Reference substance name:
1-hydroxypropan-2-yl 2-ethylhexanoate
Molecular formula:
C11H22O3
IUPAC Name:
1-hydroxypropan-2-yl 2-ethylhexanoate
impurity 1
Chemical structure
Reference substance name:
Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
IUPAC Name:
Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
impurity 2
Chemical structure
Reference substance name:
1-methylethylene 2-ethylhexanoate
EC Number:
301-185-3
EC Name:
1-methylethylene 2-ethylhexanoate
Cas Number:
93981-97-6
Molecular formula:
C19H36O4
IUPAC Name:
propane-1,2-diyl bis(2-ethylhexanoate)
impurity 3
Chemical structure
Reference substance name:
2-ethylhexanoic acid
EC Number:
205-743-6
EC Name:
2-ethylhexanoic acid
Cas Number:
149-57-5
Molecular formula:
C8H16O2
IUPAC Name:
2-ethylhexanoic acid
impurity 4
Reference substance name:
Propane-1,2-diol, propoxylated
EC Number:
500-039-8
EC Name:
Propane-1,2-diol, propoxylated
Cas Number:
25322-69-4
IUPAC Name:
Propane-1,2-diol, propoxylated
impurity 5
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Water
Test material form:
liquid: viscous
Specific details on test material used for the study:
- Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (colourless, slightly viscous)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.62 to 2.73 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: elasticated corset (TUBIGRIP) wrapped around the trunk

REMOVAL OF TEST SUBSTANCE: yes, by gentle sawbbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize J.H. (1977)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h mean values
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 72, 48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period.
Other effects:
No other effects were noted

Any other information on results incl. tables

More detailed irritation scoring can be found in the attached document below.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not a skin irritant.
Executive summary:

In this dermal irritation study, 3 young adult New Zealand rabbits, 2 males and 1 female, were exposedviathe dermal route to 0.5 ml of SER-AD FX 511 per animal. The test material was applied as a aliquid for 4 hours to a 2.5x 2.5cm of the body surface area of test animals. Animals then were observed for 7 days. Irritation was scored using the Draize scheme. Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period. In this study, SER-AD FX 511 was not a dermal irritant. On the basis of this study, SER-AD FX 511 does not warrant classification as being irritating to the skin.