Phosphoric acid, C4 and C12-14(even-numbered) Alkyl Esters, Ammonium Salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 October 1987 to 23 October 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

exposure to test material took place over 24 hours

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, mono-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Phosphoric acid, mono-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Constituent 2

Reference substance name:

Phosphoric acid, di-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Phosphoric acid, di-C4 and C12-14(even numbered) alkyl esters, Ammonium salts

Specific details on test material used for the study:

- Physical form: White to light tan paste
- Purity: 80 % active ingredient
- Lot: 751

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

ANIMAL HUSBANDRY
- Young adult male and female New Zealand White rabbits were received from Hare Marland, Hewitt, New Jersey.
- Rabbits were housed singly in suspended, stainless steel, wire-mesh cages.
- Each rabbit was assigned a unique identification number which was recorded on a card affixed to the cage.
- Purina Certified Rabbit Chow #5322 and water were available ad libitum except during the 24-hour period when exposure to test material took place.
- Rabbits were weighed and observed for general health for approximately two weeks.
- Animal rooms were maintained on a timer-controlled 12-hour light and 12-hour dark cycle.
- Target environmental conditions of the animal rooms were 20 ± 2 °C with relative humidity of 50 ± 10 %. Any excursions outside these ranges were of small magnitude and/or brief duration and did not adversely affect the validity of the study.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

48 hours

Number of animals:

Six

Details on study design:

PROTOCOL
- On the day prior to study initiation, the hair of one male and five female rabbits was closely clipped to expose the skin from the scapular to the lumbar region of the back.
- Rabbits weighed 2497 to 3498 g on the day of treatment.
- Each rabbit was placed into a stock which had been fitted with a piece of rubber sheeting approximately 8" x 18 ".
- Rabbits remained in the stocks throughout the exposure period and did not have access to food or water during that time.
- An aliquot (0.5 g) of test material was applied directly onto the test site beneath a 1" gauze square that was held in place with tape.
- The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test material in contact with the skin without undue pressure.
- Three other test materials were applied to three other sites on the same animal.
- Approximately 24 hours after application of the test material, the rubber sheeting was loosened and the skin at the corners of the gauze squares was marked with a waterproof pen. Wrappings were then removed.
- The test sites were gently washed with warm water to remove excess test material.
- The skin was gently patted dry and the animals were returned to their cages.
- Approximately 24 and 48 hours after application of the test material, the test sites were evaluated for erythema, oedema and other evidence of dermal effects.
- The test sites were scored according to the Draize scale (see Table 1, attached). Adjacent areas of skin were used for comparison.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21887

Remarks:

Blanching observed at 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Animal 21903

Remarks:

Necrosis observed at 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21904

Remarks:

Blanching observed at 48 h

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

3.5

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Animal 21912

Remarks:

Necrosis and blanching observed at 48 h

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21913

Remarks:

Blanching observed at 48 h

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

3.5

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21915

Remarks:

Blanching observed at 48 h

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21887

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

1.5

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21903

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21904

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21912

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21913

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

exposure to test material for 24 h

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 48 h

Remarks on result:

other: Animal 21915

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

exposure to test material was > 4 hours

Conclusions:

Following exposure to test material for 24 hours and grading at 24 and 48 hours, the mean scores for erythema were ≥ 2.3 in 5/6 rabbits and the mean scores for edema were ≥ 2.3 in 2/6 animals. Necrosis was observed in two rabbits and blanching was observed in five rabbits at 48 hours after treatment.

Executive summary:

In a study similar to OECD 404, the test material was evaluated for acute skin irritation in one male and five female rabbits after 24 hours exposure to the substance under occlusive conditions. Mild to severe erythema was seen at 24 hours after treatment with one rabbit exhibiting blanching. Edema was slight to moderate at 24 hours after treatment. By 48 hours, the test material produced mild to severe erythema and mild to moderate edema. Following grading at 24 and 48 hours, the mean scores for erythema were ≥ 2.3 in 5/6 rabbits and the mean scores for edema were ≥ 2.3 in 2/6 animals. Necrosis was observed in two rabbits and blanching was observed in five rabbits at 48 hours after treatment.