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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 September 1984 and 21 September 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl vinylphosphonate
EC Number:
225-076-4
EC Name:
Dimethyl vinylphosphonate
Cas Number:
4645-32-3
Molecular formula:
C4H9O3P
IUPAC Name:
Dimethyl ethenylphosphonate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
SOURCE ANIMAL
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 2.1 - 3.4 kg
- Housing: individually
- Diet: ad libitum (deionised chlorinated water)
- Water: ad libitum (Altromin)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
SOURCE ANIMAL
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 2.1 - 3.4 kg
- Housing: individually
- Diet: ad libitum (deionised chlorinated water)
- Water: ad libitum (Altromin)
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 min, 24 h, 48 h and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: patch containing the substance covered with a semi-occlusive bandage

OBSERVATION TIME POINTS
30 - 60 min, 24 h, 48 h and 72 h

SCORING SYSTEM:
- Method of calculation: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Animal 1 and 2 showed dry and demure skin after 24 h and 48 h of the application as well as brown, small-area discolorations of the skin after 48 h of the test item application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not considered to be irritating to rabbits' skin in a study according to OEC TG 404.
Executive summary:

The test item was examined for skin irritation properties in a study with 3 albino New Zealand White rabbits according to OECD TG 404. The test material was applied to the shaved intact skin of rabbits as a single dose of 0.5 mL and covered with a semi-occlusive dressing. The irritation symptoms were examined at 30 – 60 min, 24, 48 and 72 hours after the patch removal. In all animals very slight erythema (score 1) were recorded 30 – 60 min and 24 hours after patch removal. Two animals showed also very slight erythema 48 hours after patch removal. All animals were free of irritation symptoms (erythema) 72 hours after patch removal. Thus, the study was terminated after 72 hours. No oedema were observed in any animal and at any time pont.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.70, 0.70 and 0.30 and 0.00, 0.00 and 0.00 respectively.The observed symptoms were evaluated as fully reversible alterations.

Thus, the test item is not considered to be irritating to rabbits’ skin.