Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-05 to 2008-07-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study report, test prepared according to request of Swiss authority

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
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbenzene-1,4-diyl bis{4-[4-(acryloyloxy)butoxy]benzoate}
EC Number:
700-238-1
Cas Number:
132900-75-5
Molecular formula:
C35H36O10
IUPAC Name:
2-methylbenzene-1,4-diyl bis{4-[4-(acryloyloxy)butoxy]benzoate}
Constituent 2
Reference substance name:
4-({4-[4-(Acryloyloxy)butoxy]benzoyl}oxy)-2-methylphenyl 4-[4-(acryloyloxy)butoxy]benzoate
IUPAC Name:
4-({4-[4-(Acryloyloxy)butoxy]benzoyl}oxy)-2-methylphenyl 4-[4-(acryloyloxy)butoxy]benzoate
Details on test material:
Name: Me-3K4A2
Cas no.: 132900-75-5
Chemical name: Benzoic acid, 4-[4-[(1-oxo-2- propenyl)oxy]butoxy]-, 2-methyl-1,4-phenylene ester
Purpose: industrial chemical
Colour: beige
Physical state: powder
Stability in solution or suspension: probably stable
Special procedures for dose preparation: prepare freshly
Storage: 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 animal 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 the testing facility
- 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:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
The 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 at 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: all
Score:
0
Max. score:
0
Remarks on result:
other: none
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Remarks on result:
other: none
Irritation parameter:
edema score
Basis:
mean
Time point:
other: all
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 4
preventing grading of erythema

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

Other effects:
none observed

Applicant's summary and conclusion

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

2MeO3-Im4KA2 was administered on the clipped skin of 3 female New Zealand White Rabbits HsdIf:NZW at a concentration of 0.5 g and a contact area of 6 cm2 for 4 hours by a semi-occlusive dressing according to OECD guideline 404. The substance was moistened with aqua ad injectionem. The clipped other side served as a control. Limit values according to Directive 2001/59/EC. On the basis of the test results the substance should be not classified. The substance showed no effect at any observation time neither in the formation of oedema nor in the formation of erythema.