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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-08-28 to 2008-11-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study Report, study was planned for Annex VIII (monomer > 10 t/a)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

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:
Isopropenyl acetate
EC Number:
203-562-7
EC Name:
Isopropenyl acetate
Cas Number:
108-22-5
Molecular formula:
C5H8O2
IUPAC Name:
isopropenyl acetate
Details on test material:
Name: Isopropenyl acetate
Cas no.: 108-22-5
Chemical name: 1-Propen-2-ol, acetate
Active components: 100%
Purpose: industrial chemical
Colour: colourless
Physical state: liquidStorage conditions: at room temperature, protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Healthy New Zealand White Rabbits HsdIf: NZW, body weight at the
beginning of the study > 2 kg.
Source: Harlan Winkelmann GmbH, D-33178 Borchen
Three female animals were used. The animals were derived from a controlled full barrier maintained breeding
system (SPF).
- Semi-barrier in an air conditioned room
- Temperature: 18 ± 3°C (recommendations of TVT, GV-SOLAS; see
References)
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to Altromin 2123 maintenance diet for rabbits, rich in crude
fibre
- Free access to tap water (drinking water, municipal residue control,
microbiol. controlled periodically)
- Certificates of food, water and bedding are filed at testing laboratory
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatization period (at least 5 days)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: other side of animal
Amount / concentration applied:
A dose of 0.5 mL of the test item was applied to each test site.
Duration of treatment / exposure:
Test item was held in contact with the skin throughout a 4-hour period.
Observation period:
The animals were examined for signs of erythema and oedema 1, 24, 48 and
72 hours after patch removal.
Number of animals:
3
Details on study design:
The test item was applied as a single dose to a small area (approx. 6 cm²) of skin on one side of the dorsal area and covered with a gauze patch, which
was held in place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: none
Irritation parameter:
edema score
Basis:
mean
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: none
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: none
Irritant / corrosive response data:
For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 24, 48 and 72 hours after
patch removal. Dermal irritation was scored and recorded according to the grades in the table below. Any other signs such as hyperplasia, scaling,
discoloration, fissures and scabs or any systemic effects were also recorded.

Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef-redness) to eschar formation preventing grading of erythema 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approx. 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond exposure area) 4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is not irritationg to the skin.
Executive summary:

Application of 0.5 g undiluted isopropenyl acetate (99.5 % pure) to the clipped site of 3 New Zealand White rabbits was performed semi-occlusively according to OECD Guideline 404. The test substance was applicated on the clipped dorsal side of the rabbits whereas the other clipped but untreated side saved as a control. The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours. 1 hour as well as after 24, 48 and 72 hours no effects were seen on the application site concerning erythema or oedema score. There were no significant body weight changes during the contact and

observation period. Considering the reported data of this irritation study it can be stated that the test item Isopropenyl acetate showed no irritant/corrosive effects.