Polyphosphoric acids

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed according to 1500.41 in the Federal Register Vol. 38, No. 187, S. 26019 from 1973-09-27 with limited documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 1500.41 in the Federal Register Vol. 38, No. 187, S. 26019 from 1973-09-27

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Orthophosphoric acid

EC Number:

231-633-2

EC Name:

Orthophosphoric acid

Cas Number:

7664-38-2

Molecular formula:

H3O4P

IUPAC Name:

phosphoric acid

Details on test material:

- Name of test material (as cited in study report): Phosphorsaeure ca. 80 %ig (80 % phosphoric acid solution), 79/322
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: not applicable
- Isomers composition: not applicable
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.45-3.14 kg (mean: 2.79 kg)
- Housing: no data
- Diet: SSNIFF diet (Intermast), witheld during the contact period
- Water: withheld during the contact period
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1979-07-03 To: 1979-07-06

Test system

Type of coverage:

not specified

Preparation of test site:

other: all test sites were shaved, half of the test sites were abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 80 %

VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable

Duration of treatment / exposure:

24 hours

Observation period:

- Observations were performed at 24 and 72 hours and at 8 days post-dosing.

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: the test sites were covered with a rubberized covering (5 x 5 cm), fixed with bandaid strips, and wrapped with gauze.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM:
- The scoring system appears to be equivalent to the Draize scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(intact and abraded)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 72 hours post-dosing

Results 2

Irritation parameter:

edema score

Remarks:

(intact)

Basis:

mean

Time point:

other: 24 hours

Score:

2.8

Max. score:

4

Reversibility:

not fully reversible within: 72 hours post-dosing

Remarks on result:

other: 1 score was 2, 5 scores were 3

Results 3

Irritation parameter:

edema score

Remarks:

(intact)

Basis:

mean

Time point:

other: 72 hours

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours post-dosing

Remarks on result:

other: 4 scores were 2, 2 scores were 3

Results 4

Irritation parameter:

edema score

Remarks:

(abraded)

Basis:

mean

Time point:

other: 24 hours

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours post-dosing

Remarks on result:

other: all scores were 3

Results 5

Irritation parameter:

edema score

Remarks:

(abraded)

Basis:

mean

Time point:

other: 72 hours

Score:

2.2

Max. score:

4

Reversibility:

not fully reversible within: 72 hours post-dosing

Remarks on result:

other: 5 scores were 2, 1 score was 3

Results 6

Irritation parameter:

primary dermal irritation index (PDII)

Time point:

other: 72 hours

Score:

6.6

Irritant / corrosive response data:

Intact and Abraded Test Sites:
- In intact and abraded sites at 24 hours, edema and mild necrosis was observed in all animals.
- In intact sites at 72 hours, edema was observed in 3 animals and deep tissue necrosis was observed in the other 3 animals with gross pathological effects.
- In abraded sites at 72 hours, deep tissue necrosis was observed in all animals with accompanying edema in 1 animal. The necrosis was observed with gross pathological effects.

Other effects:

- All animals were sacrificed at 72 hours for humane reasons.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information 80% phosphoric acid Criteria used for interpretation of results: not specified

Conclusions:

The test substance was corrosive to the rabbit skin.