Diethyl phenylphosphonite

Endpoint summary

Description of key information

Skin: irritant (GLP, OECD 404, BASF 1998)
Eye: not irritant (GLP, OECD 405, BASF 1998)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-11-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992-07-17

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: females 3.98 kg, males 4 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area 3000 cm2
- Diet: about 130 g/day (Kliba Labordiaet 341, Klingentalmuehle AG Kaiseraugst, Switzerland), ad libitum
- Water: about 250 ml tap water per animla per day, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%):30-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied:0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

15 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5*2.5 cm
- Type of wrap if used: test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern, Germany) and Fixomull (R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: removal with Lutrol (R) E 400 (=Polyethylenglycol DAB, BASF SE) and Lutrol / water (1/1)
- Time after start of exposure: exposure period 4 h

SCORING SYSTEM: table according to OECD guideline 404 (1992-04-17)

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.9

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.9

Max. score:

4

Reversibility:

fully reversible within: 15 d

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Irritation parameter:

erythema score

Basis:

other: all animals

Time point:

other: day 15

Score:

1

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 15 d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritant / corrosive response data:

The average score (24 to 72 hours) for irritation was calculated to be 2.9 for erythema and 0.9 for edema. Erythema were not reversible in all animals within 15 days after removal of the patches (study termination).

Other effects:

Other effects were erythema extending beyond the area of exposure in all animals (at time 1 h after exposure until termination of the study), edema extending beyond the area of exposure (until 24 hours after exporsure in all animals, at time 48 h in animal 1 and 2, at time 72 h in animal 2), scaling (at the 8th day in animals 1 and 2, 15 days after exposure in all animals) and scaling beyond the area of exposure (at the 8th day in animals 1 and 2, 15 days after exposure in all animals).

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	2/2/2	3/3/3
24 h	3/3/3	1/2/1
48 h	3/3/3	1/1/0
72 h	3/3/2	1/1/0
Average 24h, 48h, 72h	3/3/2.7	1/1.3/0.3
Reversibility*)	n.c.	c.
Average time for reversion	not fully reversible within 15 d	15 d

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Interpretation of results:

irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-11-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987-02-24

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69, L383A, B5, 1992-12-29

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: females 3.06 kg, males 2.66 kg
- Housing: singel housing in stainless steel wire mesh cages with grating, floor area 3000 cm2
- Diet: standardizes laborators diet (about 130 g/animal/day), ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied:0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: scoring table according to OECD guideline 405 (1987-02-24) and EEC Directive 92/69, L 383A,B.5 (1992-12-29)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h / 48 h / 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 h / 48 h / 72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h / 48 h / 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Remarks:

within 48 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h / 48 h / 72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris and chemosis and 0.3 for conjunctivae redness. The findings were reversible in all animals within 48 hours after application.

Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	2/2/2	2/1/1
24 h	0/0/0	0/0/0	1/1/1	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Mean 24h, 48h, 72h	0/0/0	0/0/0	0.3/0.3/0.3	0/0/0
Maximum mean score	0	0	0.3	0
Reversibility*)	-	-	c.	c.
Average time for reversion	-	-	48 h	24 h

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Interpretation of results:

not irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

The potential of Diethoxyphenylphosphin to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclussive dressing.

The average score (24 to 72 hours) for irritation was calculated to be 2.9 for erythema and 0.9 for edema. The individual mean score for animal 1 (time points 24, 48, 72 hours) was 3 for erythema and 1 for edema, respectively. For animal 2 the mean erythema-score was 3 and the mean edema-score was 1.3. The mean scores over the time points 24 h, 48 h and 72 hours for animal 3 were 2.7 for erythema and 0.3 for edema. Edema were fully reversible within 8 or 15 days, but slight erythema (score 1) were still perceptible at the end of the study. Additionally scaling was observed in all animals.

The symptoms observed and described in the respective observation table in detail together with the average score for irritation indicate an irritant propterty of the test substance to the skin.

Eye:

The potential of Diethoxyphenylphosphin - DEOPP to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance on day 0.

The average score (24 to 72 h) for irritation was calculated to be 0 for corneal opacity, iris and chemosis and 0.3 for cunjunctivae redness. The individual scores (mean over the time points 24, 48 and 72 hours) for animal 1 were 0 for corneal opacity, 0 for iris, 0 for chemosis and 0.3 for conjunctivae redness. For animal 2 and 3 the same values were determined. The findings were reversible in all animals within 48 hours after application. The substance does not give indication of an irritant property in the eye under the chosen test conditions.

Justification for selection of skin irritation / corrosion endpoint:
only one reliable GLP and guideline study available

Justification for selection of eye irritation endpoint:
only one reliable GLP and guideline study available

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin:

Based on the above findings the test substance has to be classified as category 2 (irritant), according to GHS (Regulation No 1272/2008) and labelled with R38 according to EU/DPD (67/548/EEC)

Eye:

The results obtained do not give indication of an irritant property to the eye and classification is therefore not warranted based on Regulations 1272/2008 and 67/548/EEC.