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Description of key information

Skin irritation: A single in vivo study is available for skin irritation. The key study is comparable to the OECD Guideline No 404 and performed in a GLP accredited facility.

Eye irritation: Two in vivo studies are available for eye irritation. The protocol for the key study is comparable to modern day guidelines and was performed in a GLP accredited facility. The supporting study provides additional support for the conclusions reached in the key study.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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
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
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.

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

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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:
From 07/08/1986 to 12/08/1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Only two animals were tested per category (washed/unwashed eyes) not the three animals stipulated in the guideline. Effects were not severe in those animals tested.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania on July 16th, 1986
- Age at study initiation: The animals were young.
- Weight at study initiation: 2.36-2.77 kg
- Housing: Individual stainless steel cages, DAGB cageboard bedding was used in litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): fresh tap water ad libitum
- Acclimation period: July 16th 1986 - August 7th 1986


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 75 °F
- Humidity (%): 56 - 61 %
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light, 12 hours dark cycle.


IN-LIFE DATES: From: 16/07/1986 To: 12/08/1986
Vehicle:
unchanged (no vehicle)
Controls:
other: yes, the untreated left eyes served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.10 gram
Duration of treatment / exposure:
washed eyes: exposure was 20-30 seconds before the eye were rinsed.
not washed: The test material was not removed by any external processes.
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 2 of the 4 animals had their eye washed, the remaining 2 did not.
- Time after start of exposure: 20-30 seconds after treatment.
- The washed eyes were rinsed with 100 mL of tap water for 1 minute.

SCORING SYSTEM: Eyes were assessed for irritation using the method of Draize.

TOOL USED TO ASSESS SCORE: The eyes were examined with the aid of 2% fluorescein dye
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
See Table 1. One hour after dosing mild conjunctivitis was noted in all eyes. Washed eyes recovered within 24 hours of dosing, at which time both of the unwashed eyes had slight conjunctivitis. At the 48 and 72 hour scoring, one unwashed rabbit still had slight conjunctivitis. By day 4, all irritation had resolved and the test was terminated.
Washing the eyes with tap water shortly after exposure decreased both the severity and duration of the irritation observed.
Other effects:
All animals remained healthy throughout the study, except one of the rabbits subject to eye washing, this rabbit had diarrhea at 72 hours and on day 4.

Table -1. Eye scores per animal.

Animal

Time point (hours)

Cornea opacity/area

Iris Iritis

Conjunctiva

Other comments

Redness

Chemosis

Discharge

1

1

0

0

1

1

3

0

24

0

0

1

0

1

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

96

0

0

0

0

0

0

 

2

1

0

0

1

1

2

Cb*

24

0

0

1

1

1

0

48

0

0

1

0

1

0

72

0

0

1

0

0

0

96

0

0

0

0

0

0

 

3 washed eyes

1

0

0

0

1

3

0

24

0

0

0

0

0

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

96

0

0

0

0

0

0

 

4 washed eyes

1

0

0

0

0

0

0

24

0

0

0

0

0

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

96

0

0

0

0

0

0

*Cb- conjunctiva red (bloody spots)

Table 2 - Primary eye irritation indexes

Scoring intervals

Unwashed

Washed

1h

9.0

8.0

24 h

5.0

0

48 h

2.0

0

72 h

1.0

0

96 h (day 4)

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Although the study has only been conducted on two animals (unwashed eyes) it is considered to be sufficient for classification and labelling due to the minimal effects noted. This study is therefore submitted as a key study to provide the relevant classification according to Regulation (EC) No. 1272/2008 (EU CLP)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to Regulation (EC) No. 1272/2008 (EU CLP) the available data indicate that no classification is necessary for pentapotassium triphosphate with regards to skin or eye irritation.

There are no data (study or workplace observations) to suggest that pentapotassium triphosphate is a respiratory irritant.