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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, and no OECD Guideline followed. Acceptable basic data.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: U.N. Transport Regulations; U.S. Federal Regulations
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphonic acid
EC Number:
237-066-7
EC Name:
Phosphonic acid
Cas Number:
13598-36-2
Molecular formula:
H3O3P
IUPAC Name:
phosphonic acid
Constituent 2
Reference substance name:
Phosphorous acid
EC Number:
233-663-1
EC Name:
Phosphorous acid
Cas Number:
10294-56-1
IUPAC Name:
phosphorous acid
Details on test material:
- Name of test material (as cited in study report): Phosphorous acid
- Physical state: Liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd.
- Age at study initiation: no data
- Weight at study initiation: 2-3 kg
- Housing: one animal per cage
- Diet: standard rabbit diet
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 80%
Duration of treatment / exposure:
4 hours
Observation period:
3 minutes, 1, 4, 24, and 48 hours
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 1 inch square
- Type of wrap if used: the patch was covered with an overlapping patch of impermeable plastic adhesive tape. After the final application, the entire trunk was bound with Sleek occlusive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleansed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: FDA scoring system, simlar to Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: #1,3 and 5
Time point:
24 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
not determinable
Remarks:
Complete breakdown of skin with bleeding - rabbit sacrificed
Irritation parameter:
erythema score
Basis:
animal: #1,3 and 5
Time point:
24 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
not determinable
Remarks:
Complete breakdown of skin with bleeding -rabbit sacrificed
Irritation parameter:
edema score
Basis:
animal: #2,4 and 6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal: #2, 4 and 6
Time point:
24 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
not determinable
Remarks:
Dark red brown area
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: All
Time point:
other: 48/72h
Reversibility:
not reversible
Remarks on result:
not determinable
Remarks:
Substance corrosive, all animals were sacrificed
Irritant / corrosive response data:
At the 1 h reading visible necrosis of the skin was only evident in 2 of the 6 sites treated with this material. However at the 4 h reading all sites treated with phosphorous acid (80%) showed visible necrosis. Visible necrosis was evident at all treated
sites after contact of more than 3 and up to 60 minutes. It was impossible to calculate the primary irritation scores for the materials since for humane reasons the rabbits were sacrificed before the required 72 h reading could be taken.

Any other information on results incl. tables

 

Oedema mean score 

(6 rabbits)

 Erythema/Eschar mean score

(6 rabbits)

 3 minutes  0  0.25
 1 hour  0.83  2 rabbits visible necrosis
 4 hours  2  all 6 rabbits dark red brown area
 24 hours  3 rabbits dark red brown, and 3 rabbits complete breakdown of skin with bleeding; 4 rabbits sacrificed
 48 hours  2 rabbis left: blackened skin, but minimal breakdown   

Applicant's summary and conclusion

Interpretation of results:
other: Cat.1A Corrosive
Remarks:
based on CLP 67/548/EEC and 1272/2008.
Conclusions:
Phosporous acid (80%) caused visible necrosis at 2 sites after contact for 3-60 minutes in 2 of the 6 sites. The remaining 4 sites showed necrosis after contact of more than 1 hour and up to 4 hours. Based on these results and according to EU criteria Phosporous acid (80%) was considered to be corrosive and the material needs to be classified as Cat.1A Corrosive according to the classification criteria outlined in 67/548/EEC and 1272/2008.
Executive summary:

A skin corrosion study was conducted, according to U.N. Transport Regulations and U.S. Federal Regulations on 3 male and 3 female New Zealand White rabbits using the test material Phosporous acid (80%). 0.5 ml of the test material was applied under occlusion to the shaved backs of the 6 rabbits. Patch application was repeated after 3 minutes and 1 hour. The test material was not applied at further treatments after 4 hours. Observations for dermal irritation or defects were made at 3 minutes, and 1, 4, 24, and 48 hours after application of the test material. Phosporous acid (80%) caused visible necrosis at 2 sites after contact for 3-60 minutes in 2 of the 6 sites. The remaining 4 sites showed necrosis after contact of more than 1 hour and up to 4 hours. It was impossible to calculate the primary irritation score, since for humane reasons the rabbits were sacrificed before the required 72 hours reading could be taken. Based on these results and according to EU criteria Phosporous acid (80%) was considered to be corrosive and the material needs to be classified as corrosive according to the classification criteria outlined in 67/548/EEC and 1272/2008.