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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
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:
13/06/1988 to 17/06/1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, please see additional information on methods.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrapotassium pyrophosphate
EC Number:
230-785-7
EC Name:
Tetrapotassium pyrophosphate
Cas Number:
7320-34-5
Molecular formula:
H4O7P2.4K
IUPAC Name:
tetrapotassium diphosphate
Details on test material:
- Name of test material (as cited in study report): Tetrapotassium pyrophosphate
- Substance type: White solid
- Physical state: solid
- Analytical purity: data on file with sponsor
- Reference No.: 600A5072X
- Stability under test conditions: data on file with sponsor
- Storage condition of test material: Room temperature
- Other:
FMC-T#: 636
Date received: 03/05/1988
Formulation: Technical

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 May 18, 1988
- Age at study initiation: Young
- Weight at study initiation: 2.3 - 2.69 kg
- Housing: individually housed in stainless steel cages. DAGB 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): 67 - 73°F
- Humidity (%): 60 - 64 %
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light: 12 hour dark cycle.


IN-LIFE DATES: May 18, 1988 - 13/06/1988

Test system

Type of coverage:
occlusive
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

VEHICLE
no vehicle was used.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2"x2"
- % coverage: no data
- Type of wrap if used: The test site was covered with an eight-ply, 2"x2" gauze pad which was secured with hypoallergenic tape. The entire trunk of the animal was wrapped in a semi-occlusive cheesecloth bandage. Elizabethan collars were also fitted to prevent disturbance of the test site.
- Other: Once unwrapped the test site was allowed to "rest" for 30 minutes to allow for regression of pressure and hydration effects.
- There were two test sites per animal, either side of the spinal chord served as a separate site.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was wiped clean with methanol then rinsed with tap water.
- Time after start of exposure:Four hours after application

SCORING SYSTEM: Draize, Woodard and Calvery. J. Pharm. Exp. Ther., 83, 384 (1944)

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
Irritation parameter:
edema score
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
See Table 1.
Other effects:
All animals remained healthy throughout the study.

Any other information on results incl. tables

Table 1 - Individual skin scores at 4.5 hours, 0.5 hours after the wrapping was removed.

Animal / sex

Left

Right

ER

ED

other

ER

ED

other

1 / male

1

0

0

1

0

0

2 / female

0

0

0

0

0

0

3 / male

0

0

0

0

0

0

Irritation score = 0.3/ 8.0

ER - erythema/ eschar

ED - edema

other - other comments

Zero scores were observed at all subsequent time points, i.e. 24h, 48h, and 72h.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study and based on the Primary Irritation Index, the test material is non-irritating to intact skin when applied topically to New Zealand White rabbits.
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling. Tetrapotassium pyrophosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP) as no effects were noted for the relevant parameters (erythema/eschar or oedema).