Phosphoric acid, dodecyl ester, potassium salt

Endpoint summary

Description of key information

The test item was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. The only deviation was that the test item was applied as 77% paste in water, but since according to the guideline dry powders have to be moistened, the testing conditions and results are considered to be the same. Effects on the skin (erythema grades up to 4 and edema scores up to 3) were observed in all animals 24 hours after application. These signs were reversible within the 21 days observation period.
The test item was tested for its eye irritant properties in 3 New Zealand White rabbits.The study was performed according to OECD Guideline 405. The only deviation was that the test item was applied as 77% paste in water, but since the dry powder is moistened when it comes in contact with the eye, the testing conditions and results are considered to be the same. 
Effects on conjunctivae (redness and swelling), iris and cornea were observed in all animals one hour after application. These signs were irrevesible in 2 of 3 animals.

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:

16. Dec 1986 - 06. Jan 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP- and guideline-conform study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

test item was applied as 77% paste in water

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Ag, Kastengrund, conventional breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3 - 3,4 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 (Altromin GmbH, Lage/Lippe, Germany) ad libitum, 15 g hay/day
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/-20 %
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 16. Dec. 1986 To: 06. Jan. 1987

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg of 77% test substance in water

Duration of treatment / exposure:

4 h

Observation period:

a. 30-60 min post applicationem
b. 24 h post applicationem
c. 48 h post applicationem
d. 72 h post applicationem
e. 7 d post applicationem
f. 14 d post applicationem
g. 21 d post applicationem

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
- Type of wrap if used: The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skinarea and covered with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.89

Max. score:

4

Reversibility:

fully reversible within: 21 d

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 d

Other effects:

Treated skin areas were mostly dry and rough.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With reference the reported scores and the reversibility of the observed effects the test item has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Executive summary:

The test item was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. The only deviation was that the test item was applied as 77% paste in water, but since according to the guideline dry powders have to be moistened, the testing conditions and results are considered to be the same. Effects on the skin (erythema grades up to 4 and edema scores up to 3) were observed in all animals 24 hours after application. These signs were reversible within the 21 days observation period.

With reference the reported scores and the reversibility of the observed effects the test item has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation, skin irritant category 2) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

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:

13. Jan - 20. Jan 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline and GLP conform study with sufficient reporting.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

77% paste in water tested

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,5 - 3,3 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 (Altromin GmbH, Lage/Lippe, Germany) ad libitum, 15 g hay/day
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/-20 %
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 13. Jan 1987 To: 20. Jan. 1987

Vehicle:

water

Controls:

not required

Amount / concentration applied:

100 mg of 77% test substance in water

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1 hour post application
24 hours post application
48 hours post application
72 hours post application
7 days post application

Number of animals or in vitro replicates:

3

Details on study design:

The eyes were examined 1, 24, 48, 72 hours and 7 days after application of the test substance.
24 hours after treatment the eyes were washed out with physological saline.
At 48 and 72 hours the eyes were also examined after instillation of one drop of 0.01 % fluorescein-sodium solution.

SCORING SYSTEM:

A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4

IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2

CONJUNCTIVAE

A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3

B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.6

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.7

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.7

Max. score:

2

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.1

Max. score:

4

Reversibility:

not reversible

Individual scores:

Time after appl.	60 min.	24 h	48 h	72 h	7 d
Animal No.	1      2    3	1      2     3	1      2    3	1      2     3	1      2     3
Conjunctivae score	3      3    3	2      3     3	3      2    3	3      1     3	3     0     3
Chemosis score	3      2    3	1       1     2	1      1     3	2      1      3	2     0     2
Iris score	1      1     1	1       0      1	1      0     1	1      0      1	1     0     1
Cornea score	1      0     2	1       0      1	1      0     3	1      0      3	4     0     4

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With reference the reported scores and the irreversibility of the observed effects Leomin PN has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Executive summary:

The test item was tested for its eye irritant properties in 3 New Zealand White rabbits.The study was performed according to OECD Guideline 405. The only deviation was that the test item was applied as 77% paste in water, but since the dry powder is moistened when it comes in contact with the eye, the testing conditions and results are considered to be the same.

Effects on conjunctivae (redness and swelling), iris and cornea were observed in all animals one hour after application. These signs were irrevesible in 2 of 3 animals.

With reference the reported scores and the irreversibility of the observed effects the test item has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation: 1 key study and 1 abstract available: irritating

Eye irritation: 1 key study and 1 abstract available: corrosive

 

There are one reliable study and one abstract available on the skin irritancy potential. Phosphoric acid, dodecyl ester, potassium salt was tested for its skin irritant properties in 3 New Zealand White and 6 Albino Russian rabbits. The studies were performed according to OECD Guideline 404. Deviations were the application as 77% paste (key study) and a prolonged exposure period (24 hours; supporting study). Effects on the skin (erythema grades up to 4 and edema scores up to 3) were observed in all animals 24 hours after application.These signs were reversible within the 21 days observation period.

There are one reliable study and one abstract available on the eye irritancy potential. Phosphoric acid, dodecyl ester, potassium salt was tested for its eye irritant properties in 3 New Zealand White and 3 Albino Russian rabbits. These studies were performed according to OECD Guideline 405 and FDA, Federal Register Vol. 37, No. 38, 1972, respectively. Effects on conjunctivae (redness and swelling), iris and cornea were observed in all animals one hour after application.These signs were irrevesible in 2 of 3 animals.

Justification for selection of skin irritation / corrosion endpoint:
GLP- and guideline-conform study with sufficient reporting.

Justification for selection of eye irritation endpoint:
Guideline and GLP conform study with sufficient reporting.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

With reference the reported scores and the reversibility of the observed effects Phosphoric acid, dodecyl ester, potassium salt has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation, skin irritant category 2) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

With reference the reported scores and the irreversibility of the observed effects Phosphoric acid, dodecyl ester, potassium salt has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).