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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16/06/1988 to 30/06/1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FMC Non-Definitive Dermal Toxicity Protocol (Number 7)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
see any additional information on methods.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
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.: 600A-5072X
- 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
Sex:
male/female
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: 2.21 - 2.74 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 - 74°F
- Humidity (%): 52 - 69 %
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light: 12 hour dark cycle.


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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
The test material was weighed out onto a 4" by 4" 8-ply gauze pad. The gauze was held in place with hypoallergenic tape. The test site was occluded with impervious plastic sheeting. Immediately after dosing each animal was fitted with an everted plastic Elizabethan collar. The collars remained in place until termination of the study.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hour after exposure the wrapping was removed. The test site was wiped cleaned with a gauze moistened with methanol and then rinsed with tap water.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Please see additional information on materials and methods.
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICLE
- The test material was moistened with physiological saline.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6: 3 female, 3 males each at 2000 mg/kg bw.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14
- Frequency of observations and weighing: The animals were observed for mortality and clinical signs ( local irritation excluded) at approximately 3 hours after dosing and daily thereafter for 14 days. Bodyweights were taken on the day of dosing and again on days 7 and 14. A description of the local irritation was recorded on days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None of the animals died during the study
Clinical signs:
All animals remained healthy durng the observation period.
Body weight:
See Table 1. All but one rabbit gained weight during the study.
Gross pathology:
No gross lesions were found.
Other findings:
Results for local irritation are reported in Table 2.

Any other information on results incl. tables

Table 1 - Individual bodyweights

Animal # / sex

Day 0

(kg)

Dose

(g)

Amount applied

(mg/cm2)

Day 7

(kg)

Day 14

(kg)

1 / male

2.21

4.4

42.7

2.27

2.42

2 / male

2.66

5.3

51.5

2.65

2.78

3 / male

2.25

4.5

43.7

2.27

2.36

Mean ± SD

2.37 ± 0.249

 

46.0 ± 4.82

2.40 ± 0.219

2.52 ± 0.227

 

 

 

 

 

 

4 / female

2.55

5.1

49.5

2.69

2.85

5 / female

2.74

5.5

53.4

2.40

2.64

6 / female

2.54

5.1

49.5

2.56

2.60

Mean ± SD

2.61 ± 0.113

 

50.8 ± 2.25

2.55 ± 0.145

2.70 ± 0.134

Table 2 - Local irritation

Animal # / sex

Day 1

Day 3

Day 7

Day 14

(kg)

1 / male

N

N

De

De

2 / male

Er

Er

Es

Es, De

3 / male

Ed, Ne, Cb

Ed, Ne, Cb

Ts, Ne,Cb

Ne, Es, Ex, Tb, Ts

 

 

 

 

 

4 / female

Er

Er

Es, Tb

Es

5 / female

Er

N

N

N

6 / female

N

N

Es, Ts, Tb

Es, Ex

N - normal

De - desquamation

Er - Erythema

Ed - Edema

Ne - Necrosis

Cb - Chemcially burned

Ts - Skin thickening

Ex - Exfoliation

Tb - Tissue bleeding

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test material is approximated to be relatively non-toxic.

In accordance with Regulation (EC) No. 1272/2008 (EU CLP) tetrapotassium pyrophosphate is not considered to be acutely toxic via the dermal route.