Dimethyl vinylphosphonate

Endpoint summary

Description of key information

Skin: The test matarial was not irritating to the rabbits' skin under the test conditions chosen.

Eye: The test matarial was not irritating to the rabbits' eye under the test conditions chosen.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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

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.

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.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 September 1984 and 28 September 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 3.0 - 4.2 kg
- Housing: individually
- Diet: ad libitum (Altromin 2123)
- Water: ad libitum (deionised, chlorated water)

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

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after application

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

- 1 hour after application: Animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally.
- 24 hours after application: Two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.
- 72 hours after application: All animals were symptom-free.

Other effects:

- Ophthalmoscopic findings: none

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not considered to be irritanting to rabbits' eye according to OECD TG 405.

Executive summary:

The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application.

One hour after application animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally. 24 hours after application two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.

All animals were symptom-free 72 hours after application.

For animal 1 and 2, the mean scores (considering readings at 24, 48 and 72 hours after test item application) were 0 for cornea opacity, 0 for iris, 0 for conjunctivae redness and 0 for chemosis. For animal 3, the mean scores were 0.7 for corneal opacity, 0.7 for iris, 1.3 for conjunctivae redness and 1.0 for chemosis. Therefore, the test item is not considered to be irritating to rabbits’ eye.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

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.

Eye irritation/corrosion

The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application.

One hour after application animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally. 24 hours after application two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.

All animals were symptom-free 72 hours after application.

For animal 1 and 2, the mean scores (considering readings at 24, 48 and 72 hours after test item application) were 0 for cornea opacity, 0 for iris, 0 for conjunctivae redness and 0 for chemosis. For animal 3, the mean scores were 0.7 for corneal opacity, 0.7 for iris, 1.3 for conjunctivae redness and 1.0 for chemosis. Therefore, the test item is not considered to be irritating to rabbits’ eye.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

Based on the available experimental data, the substance is not considered to be classified for skin irritation or eye irritation under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.