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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted according to OECD guideline No. 404 and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

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:
Soybean oil, epoxidized, acrylate
EC Number:
294-415-6
EC Name:
Soybean oil, epoxidized, acrylate
Cas Number:
91722-14-4
Molecular formula:
C63H108O15
IUPAC Name:
Soybean oil, epoxidized, acrylate
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SAT 981 170 (PHOTOMER 3005 F)
- Substance type: UVCB
- Physical state: yellowish to brownish, viscous liquid
- Lot/batch No.: 3828246463
- Expiration date of the lot/batch: 14 April 1999
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: Albino rabbits of stiock Mol:Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted compete rabbit diet "Altromin 2123", ad libitum
- Water (e.g. ad libitum): domestic quality drinking water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

IN-LIFE DATES: From: To: 4 January 1999 - 12 January 1999

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Number of animals:
Three female rabbits
Details on study design:
TEST SITE
- Area of exposure: an area of 10 x 10 cm was clipped and divided into four fiels. The two anterior fields were used for testing the substance.
- Type of wrap if used: to each of two 16-layer gauze patches (2.5 x 2.5 cm) 0.5 ml of the test substance was applied, and the patches were placed on the appropriate test site on the back of each rabbit. The gauze patches were secured with 2.5 cm wide adhesive Gothaplast tape and fixed with Gothaplast tape, 5 cm width, loosely woud around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned with mild soap and luke warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Skin readings for erythema/easchar and oedema formation were made 1, 24, 48 and 72 hours as well as 7 days after termination of exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria listed in Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as a skin irritant.
Executive summary:

The primary skin irritant effect of the test substance was investigated according to the method recommended in OECD guideline No. 404 "Acute Dermal Irritation/Corrosion", 1992 and EEC Guideline B.4 "Acute Toxicity (Skin Irritation)", 29.12.1992.

Three female albino rabbits were exposed to the test substance at two skin site on the back. After 4 hours of exposure the test substance was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7 days after termination of exposure.

Slight to well-defined skin reactions were observed among the rabbits, but the mean scores at 24, 48 and 72 hours were below the EC criteria for skin irritation. Effects were fully reversible at 7 days after termination of exposure, except some slight scale formation on the skin of one rabbit.

In conclusion, according to Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as a skin irritant.