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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium Hexametaphosphate
- Substance type: White powder
- Physical state: solid
- Analytical purity: not determined
- Reference No.: B578AB101
- Stability under test conditions: Not determined
- Storage condition of test material: Room temperature
- Other:
FMC-T#: 861
Date received: May 9, 1990

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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: 2.06 - 2.35 kg
- Housing: individually housed in stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326 was provided
- Water (e.g. ad libitum): fresh tap water was provided
- 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: June 6, 1990 to termination ca. mid 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, 1 female and 2 males, were used in this study, per animal two test sites were dosed either side of the spinal column.
Details on study design:
TEST SITE
- Area of exposure: 2" by 2"
- % coverage:
- administration of the test material: The test material was weighed onto an 8-ply, 2"x2" gauze pad and moistened. The pad was secured with hypoallergenic tape. The entire trunk of the animal was wrapped with a semi-occlusive cheesecloth bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, a gauze pad moistened with methanol was used to wipe the test site, the test site was then rinsed with tap water.
- Time after start of exposure: 4 h

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:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The only irritation noted was slight erythema in one rabbit 4.5 h after dosing. All irritation resolved within 24h, and the test was terminated following the 72 h scoring.
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

Animal # / sex

Left

Right

ER

ED

O

ER

ED

O

1 / female

1

0

0

1

0

0

2 / male

0

0

0

0

0

0

3 / female

0

0

0

0

0

0

Irritation score = 0.3/ 8.0

ER - erythema and eschar scores

ED - edema

O - Other comments

At all subsequent time points, i.e. at 24 h, 48 h and 72 h, zero scores were recorded for all test sites.

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 slightly 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. Sodium metaphosphate 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) at 24, 48 and 72 hours after exposure.