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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
In vivo. Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
A GLP study which is comparable to OECD Guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FMC Non-Definitive Primary Skin Irritation Protocol (Number 10)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
please see additional information on materials and methods.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentapotassium triphosphate
EC Number:
237-574-9
EC Name:
Pentapotassium triphosphate
Cas Number:
13845-36-8
Molecular formula:
H5O10P3.5K
IUPAC Name:
pentapotassium triphosphate
Details on test material:
- Name of test material (as cited in study report): Potassium tripolyphosphate
- Substance type: White powder
- Physical state: solid
- Analytical purity: not determined
- Reference No.: 527A31082
- Stability under test conditions: Not determined
- Storage condition of test material: Room temperature
- Other:
FMC-T#: 859
Date received: June 1, 1990

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania on June 6, 1990.
- Age at study initiation: Young
- Weight at study initiation: 2.23 - 2.52 kg
- Housing: individually housed in stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): ad libitum; Purina High Fiber Rabbit Chow 5326
- Water (e.g. ad libitum): ad libitum; fresh tap water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 72°F
- Humidity (%): 51 - 66 %
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light: 12 hour dark cycle.

IN-LIFE DATES: From June 6, 1990 - termination, ca. 31st June 1990

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The test material was moistened with physiological saline.
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gram
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 animals, each with two test sites.
1 female, 2 males.
Details on study design:
TEST SITE
- Area of exposure: 2" x 2"
- % coverage: no data
- administration of test material: The test material, moistened with saline, was applied to an 8-ply gauze pad and secured with hypoallergenic tape. The entire trunk of the animal was wrapped with semi-occlusive cheesecloth bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped with a gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: 4 h post application of the test material.
- Other: The test sites were allowed to 'rest' for 30 minutes after the wrapping and pads were removed.

SCORING SYSTEM: Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of:
Draize J. H., G. Woodard and H. O. Calvery, J. Pharmacol. Exp. Ther., 83, 384 (1944). The 30 minute delay was instituted to allow for regression of pressure and hydration effects.

RATING SYSTEM:
- Non Irritating: No irritation observed in any animal at any scoring interval.
- Slightly irritating: Any animal exhibiting scores of 1 or less at any scoring interval and irritation clearing within 72 hours.
- Mildly irritating: Any animal exhibiting scores of 2 or less at any scoring interval and irritationg clearing within 7 days.
- Moderately irritating: Any animal exhibiting scores of 3 or less at any scoring interval and irritation clearing within 7 days.
- Severely irritating: Any animal exhibiting scores of 4 or less at any scoring interval

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Zero scores were recorded at all time points for all test sites.
Other effects:
All animals remained healthy throughout the study.

Any other information on results incl. tables

Zero scores were recorded at all time points and at all test sites.

Results of skin irritation study:

Animal

No.

Left

Right

Oedema

Erythema

Oedema

Erythema

4.5 hours

B7871F

0

0

0

0

B7860M

0

0

0

0

B7861M

0

0

0

0

24 hours

B7871F

0

0

0

0

B7860M

0

0

0

0

B7861M

0

0

0

0

48 hours

B7871F

0

0

0

0

B7860M

0

0

0

0

B7861M

0

0

0

0

72 hours

B7871F

0

0

0

0

B7860M

0

0

0

0

B7861M

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study and based on the FMC rating system, the test material is temporarily approximated to be non-irritating to intact skin when applied topically to New Zealand White rabbits.

This study is conducted according to an appropriate guideline and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint. Therefore according to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances the test material is not considered to be classified for skin irritation.

Executive summary:

no data