Registration Dossier
Registration Dossier
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EC number: 231-509-8 | CAS number: 7601-54-9
Endpoint summary
Administrative data
Description of key information
Skin irritation: A number of in vivo studies are available to assess the skin irritation potential of trisodium orthophosphate anhydrous and trisodium orthophosphate dodecahydrate. The study reported by Henderson L (1974) as the key study is conducted according to modern standards and has been chosen as a key study because it has been conducted on the anhydrous form of trisodium orthophosphate. The conclusions made in the key study are supported by a number of reliable supporting studies that have been conducted on trisodium orthophosphate dodecahydrate. The results of this study are sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
Eye irritation: A number of in vivo studies are available to assess the eye irritancy potential of trisodium orthophosphate anhydrous or trisodium orthophosphate dodecahydrate. Two studies (Glaza SM, 1992 and Glaza SM, 1992), conducted on trisodium orthophosphate dodecahydrate have been chosen as a weight of evidence for this endpoint. These studies have been conducted at two different temperatures (10°C and 22°C), both studies indicate that trisodium phosphate is irritating to the eyes but the degree of severity of the effects, in particular with respect to redness of the conjunctivae, varies depending on the temperature of the solution. The supporting data for this are not sufficient for use as key data as no total scores are provided. However, the data does support the conclusion that trisodium orthophosphate is irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- 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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FDA revision of the test for primary skin irritants, Part 191, Chapter 1, Title 21.
- Deviations:
- yes
- Remarks:
- The proposed test differs from the procedure described in the Hazardous Substances Labeling Act, Part 191.11, Chapter 1, Title 21 in that irritation is determined after a 4-h exposure period, rather than after the previously required 24-h exposure period.
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Preparation of test site:
- other: Intact skin
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- 48 h
- Observation period:
- 96 h
- Number of animals:
- Six
- Details on study design:
- No data
- Irritation parameter:
- other: Primary irritant score
- Basis:
- other: no data
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: mean 4, 24 and 48 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable; no effects noted
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: mean 4, 24 and 48 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable; no effects noted
- Irritant / corrosive response data:
- Rabbits had no edema or erythema at all observation periods.
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Trisodium phosphate was not considered to be irritating under the conditions of the study.
This study is considered to be adequate and reliable for use as a key study for this endpoint. The data in the study suggests that under test conditions trisodium phosphate is not irritating to the skin, in accordance with Regulation (EC) No. 1272/2008.
Reference
Table 1. Results of a skin irritation study in rabbits with trisodium phosphate.
Rabbit No |
Erythema-eschar observation |
Edema observation |
Sum total |
Score* |
||||
4 h |
24 h |
48 h |
4 h |
24 h |
48 h |
|||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0
|
0
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0
|
0
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0
|
0
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0
|
0
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
* Sum of individual values for each rabbit divided by 6.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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:
- 03-03-92 to 03-26-92
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
The source substance and the target substance are considered to be similar enough to facilitate read-across for the following reasons because the only difference is that the source is the hydrated form.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.
4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’ - Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Adult
- Weight at study initiation: 2322 to 2600g
- Housing: Individually in screen-bottom cages
- Diet: Measured amount of High Fibre Rabbit Chow.
- Water: Ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 24 ºC
- Humidity (%): 40 to 52 %
IN-LIFE DATES: From: 1992-03-03 To: 1992-03-26 - Vehicle:
- water
- Controls:
- other: The left eye served as the untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 15 % w/v mixture
- The prepared test mixture was kept at 10 ºC during administration
- The pH of the prepared test mixture was determined to be 12.8 - Duration of treatment / exposure:
- Group 1: Remained unwashed
Group 2: 30 seconds post instillation - Observation period (in vivo):
- The treated eyes were observed for ocular irritation at 1, 24, 48, 72 and 96 h, and Days 7 and 14 after treatment.
Animals were weighed just before test material administration and at weekly intervals throughout the study. - Number of animals or in vitro replicates:
- Group 1: 6 rabbits
Group 2: 3 rabbits - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Group 1 remained unwashed. Group 2 was flushed with lukewarm tap water for 1 minute
- Time after start of exposure: 30 sec after instillation of the test material
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Sodium fluorescein - Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: F40185
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: F40186
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: F40187
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: F40191
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: F40189
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: F40190
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: All 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: F40185
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: F40186
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal: F40187
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: F40191
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal: F40189
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: F40190
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: F40185
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: F40186
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: F40187
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: F40191
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: F40189
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: F40190
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritant / corrosive response data:
- In treated eyes receiving a washout, the test material produced corneal and iridial involvement and slight to moderate conjunctival irritation. Irritation continued to be present in the treated eyes of 4 of the animals in group 1 (unwashed eye) at Day 21 after treatment. All treated eyes of the animals in group 2 (washed eyes) had returned to normal appearance by Day 21 after treatment.
- Other effects:
- No data
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Author's conclusions: The test material, trisodium phosphate dodecahydrate (prepared as a saturated solution at 10°C), when evaluated for it's primary eye irritation potential in rabbits, produced iridial involvement and moderate to severe conjunctival irritation in unwashed eyes. In treated eyes receiving a washout, the test material produced iridal involvement and slight to moderate conjunctival irritation. All treated eyes were normal by day 14.
This study is considered to be reliable and relevant to support the classification of trisodium orthophosphate as irritating to the eyes (Cat 2) as part of a weight of evidence approach. - Endpoint:
- eye 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:
- 03-03-92 to 03-26-92
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
The source substance and the target substance are considered to be similar enough to facilitate read-across for the following reasons because the only difference is that the source is the hydrated form.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.
4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’ - Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Hra: (NZW) SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Adult
- Weight at study initiation: 2220 to 2936 g
- Housing: Individually in screen-bottom cages
- Diet: Measured amount of High Fibre Rabbit Chow.
- Water: Ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 24 ºC
- Humidity (%): 40 to 52 %
IN-LIFE DATES: From: 1992-03-03 To: 1992-03-26 - Vehicle:
- water
- Controls:
- other: The left eye served as the untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 19 % w/v mixture
- The prepared test mixture was kept at 22 ºC during administration
- The pH of the prepared test mixture was determined to be 12.6 - Duration of treatment / exposure:
- Group 1: Remained unwashed
Group 2: 30 seconds - Observation period (in vivo):
- The treated eyes were observed for ocular irritation at 1, 24, 48, 72 and 96 h, and Days 7, 14 and 21 after treatment.
Animals were weighed just before test material administration and at weekly intervals throughout the study. - Number of animals or in vitro replicates:
- Group 1: 6 rabbits
Group 2: 3 rabbits - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Group 1 remained unwashed. Group 2 was flushed with lukewarm tap water for 1 minute
- Time after start of exposure: 30 sec after instillation of the test material
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Sodium fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- other: 3 out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: the 3 remaining animals had scores < 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- In treated eyes receiving a washout, the test material produced corneal and iridial involvement and slight to moderate conjunctival irritation. Irritation continued to be present in the treated eyes of 4 of the animals in group 1 (unwashed eye) at Day 21 after treatment. All treated eyes of the animals in group 2 (washed eyes) had returned to normal appearance by Day 21 after treatment.
- Other effects:
- No data
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance produced moderate to severe conjunctival irritation in unwashed eyes. In eyes receiving washout, the test material produced corneal and iridial involvement and slight to moderate conjunctival irritation.Some minor redness was noted up to day 21 however, in conjunction with the other key study a classification of corrosive is not considered to be necessary as the substance tested (trisodium orthophosphate dodecahydrate) is a crystalline form is more difficult to dissolve in solution and therefore it is likely that the persistent redness is due to crystaline material irritating the mucosa of the eye as opposed to the local effects of the substance itself.
This study is considered to be reliable and relevant to support the classification of trisodium orthophosphate as irritating to the eyes (Cat 2) as part of a weight of evidence approach.
Referenceopen allclose all
Table 2. Average Primary Eye Irritation Score*
Observation period |
Average score |
|
Group 1 |
Group 2 |
|
1 h |
12.7 |
9.7 |
24 h |
11.7 |
9.0 |
48 h |
8.7 |
8.3 |
72 h |
6.3 |
4.0 |
96 h |
4.3 |
2.0 |
Day 7 |
3.0 |
0.7 |
Day 14 |
0.0 |
0.0 |
*the average primary eye irritation score is the total eye irritation score for all the animals divided by the number of animals (6 or 3) at each observation period.
Table 2. Individual eye irritation scores Group 1 (unwashed):
Animal No. |
Cornea |
Iris |
Conjunctivae |
Total Score* |
|||
A |
B |
C |
D |
E |
F |
||
1 h |
|||||||
F40185u |
0 |
0 |
0 |
2b |
1 |
2c |
10 |
F40186u |
0 |
0 |
1i |
2b |
2 |
2c |
17 |
F40187t |
0 |
0 |
0 |
2b |
2 |
2c |
12 |
F40191u |
0 |
0 |
1i |
2b |
1 |
2c |
15 |
F40189t |
0 |
0 |
0 |
2b |
1 |
2c |
10 |
F40190t |
0 |
0 |
0 |
2b |
2 |
2c |
12 |
Mean |
12.7 |
||||||
24 h |
|||||||
F40185 |
0 |
0 |
0 |
2b |
1 |
2c |
10 |
F40186 |
0 |
0 |
1i |
2b |
1 |
2c |
15 |
F40187 |
0 |
0 |
0 |
2b |
2 |
2c |
12 |
F40191 |
0 |
0 |
1i |
2b |
1 |
2c |
15 |
F40189 |
0 |
0 |
0 |
2 |
1 |
2c |
10 |
F40190 |
0 |
0 |
0 |
2b |
1 |
1c |
8 |
Mean |
11.7 |
||||||
48 h |
|||||||
F40185 |
0 |
0 |
0 |
2 |
1 |
1c |
8 |
F40186 |
0 |
0 |
0 |
3a |
1 |
1c |
10 |
F40187 |
0 |
0 |
0 |
2 |
2 |
2c |
12 |
F40191 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
F40189 |
0 |
0 |
0 |
2 |
1 |
1c |
8 |
F40190 |
0 |
0 |
0 |
2 |
1 |
1c |
8 |
Mean |
8.7 |
||||||
72 h |
|||||||
F40185 |
0 |
0 |
0 |
1 |
1 |
0 |
4 |
F40186 |
0 |
0 |
0 |
3a |
1 |
0 |
8 |
F40187 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40191 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
F40189 |
0 |
0 |
0 |
3a |
1 |
0 |
8 |
F40190 |
0 |
0 |
0 |
3a |
1 |
0 |
8 |
Mean |
6.3 |
||||||
96 h |
|||||||
F40185 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40186 |
0 |
0 |
0 |
3a |
1 |
0 |
8 |
F40187 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40191 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40189 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40190 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
Mean |
4.3 |
||||||
Day 7 |
|||||||
F40185 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40186 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40187 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40191 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40189 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40190 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
Mean |
3.0 |
||||||
Day 14 |
|||||||
F40185 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40186 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40187 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40191 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40189 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40190 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
0 |
||||||
Table 3. Individual eye irritation scores for group 2 (washed):
Animal No. |
Cornea |
Iris |
Conjunctiva |
Total score* |
|||
A |
B |
C |
D |
E |
F |
||
1 h |
|||||||
F40188u |
0 |
0 |
0 |
2b |
1 |
1c |
8 |
F40192t |
0 |
0 |
1i |
2b |
1 |
1c |
13 |
F40193u |
0 |
0 |
0 |
2b |
1 |
1c |
8 |
Mean |
9.7 |
||||||
24 h |
|||||||
F40188 |
0 |
0 |
0 |
2b |
1 |
1c |
8 |
F40192 |
0 |
0 |
1i |
2b |
1 |
0 |
11 |
F40193 |
0 |
0 |
0 |
2b |
1 |
1c |
9 |
Mean |
9.0 |
||||||
48 h |
|||||||
F40188 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
F40192 |
0 |
0 |
1i |
2 |
1 |
0 |
11 |
F40193 |
0 |
0 |
0 |
2 |
1 |
1c |
8 |
Mean |
8.3 |
||||||
72 h |
|||||||
F40188 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40192 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40193 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
Mean |
4.0 |
||||||
96 h |
|||||||
F40188 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40192 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40193 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
Mean |
2.0 |
||||||
Day 7 |
|||||||
F40188 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40192 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40193 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
0.7 |
||||||
Day 14 |
|||||||
F40188 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40192 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40193 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
0.0 |
||||||
A: Cornea - degree of opacity
B: Cornea - area of involvement
C: Iris - degreeof iridial irritation
D: Conjunctivae - redness
E: Conjunctivae - Chemosis
F: Conjunctivae - Discharge
*: total score = (A x B x 5)+ (C x 5) + [(D + E + F) x 2].
a: Petite haemorrhaging
b: Blanching
c: Clear discharge
i: Injected
t: No pain response after test material instillation
u: Excessive pawing at the treated eye after test material instillation
Table 4. Sodium fluorescein examination (unwashed & washed):
Animal No. |
Sex |
Pre- initiation |
Observation period |
||
72 h |
Day 7 |
Day 14 |
|||
F40185 |
Male |
Neg |
Neg |
Neg |
Neg |
F40186 |
Male |
Neg |
Neg |
Neg |
Neg |
F40187 |
Male |
Neg |
Neg |
Neg |
Neg |
F40191 |
Male |
Neg |
Neg |
Neg |
Neg |
F40189 |
Female |
Neg |
Neg |
Neg |
Neg |
F40190 |
Female |
Neg |
Neg |
Neg |
Neg |
Neg: Negative stain retention
Table 2. Average Primary Eye Irritation Score*
Observation period |
Average score |
|
Group 1 |
Group 2 |
|
1 h |
20.5 |
17.3 |
24 h |
19.0 |
14.3 |
48 h |
20.2 |
6.7 |
72 h |
21.3 |
6.0 |
96 h |
14.8 |
3.3 |
Day 7 |
9.2 |
2.7 |
Day 14 |
4.5 |
0.7 |
Day 21 |
2.5 |
0.0 |
* the average primary eye irritation score is the total eye irritation score for all the animals divided by the number of animals (6 or 3) at each observation period.
Table 3. Individual eye irritation scores Group 1 (unwashed):
Animal No. |
Cornea |
Iris |
Conjunctivae |
Total Score* |
|||
A |
B |
C |
D |
E |
F |
||
1 h |
|||||||
F39914t |
1 |
1 |
1i |
3b |
3 |
3c |
28 |
F39937u |
1 |
1 |
0 |
2b |
3 |
3c |
21 |
F39939t |
0 |
0 |
0 |
2b |
1 |
2c |
10 |
F40197t |
1 |
1 |
1i |
2b |
2 |
2c |
22 |
F40198u |
1 |
1 |
1i |
2b |
2 |
2c |
22 |
F40199u |
1 |
1 |
1i |
2b |
2 |
1c |
20 |
Mean |
20.5 |
||||||
24 h |
|||||||
F39914 |
1 |
1 |
1i |
3b |
3 |
3c |
28 |
F39937 |
1 |
1 |
0 |
2b |
3 |
3c |
21 |
F39939 |
0 |
0 |
0 |
2b |
1 |
1c |
8 |
F40197 |
1 |
1 |
0 |
2b |
1 |
2c |
15 |
F40198 |
1 |
1 |
1i |
2b |
2 |
2c |
22 |
F40199 |
1 |
1 |
1i |
2b |
2 |
1c |
20 |
Mean |
19.0 |
||||||
Individual eye irritation scores unwashed continued:
Animal No. |
Cornea |
Iris |
Conjunctivae |
Total Score* |
|||
A |
B |
C |
D |
E |
F |
||
48 h |
|||||||
F39914 |
1 |
1 |
1 |
3 |
3 |
3 |
28 |
F39937 |
1 |
1 |
0 |
3 |
2 |
1 |
17 |
F39939 |
0 |
0 |
0 |
3 |
1 |
1 |
10 |
F40197 |
1 |
1 |
0 |
2 |
1 |
1 |
13 |
F40198 |
1 |
2 |
1 |
3 |
2 |
3 |
31 |
F40199 |
1 |
1 |
1 |
3 |
2 |
1 |
22 |
Mean |
20.2 |
||||||
72 h |
|||||||
F39914 |
1j |
1 |
1i |
3a ,b |
3 |
3c |
28 |
F39937 |
1j |
1 |
1i |
3a ,b |
3 |
0 |
22 |
F39939 |
0 |
0 |
0 |
3a ,b |
3 |
0 |
12 |
F40197 |
1j |
1 |
0 |
3a |
2 |
0 |
15 |
F40198 |
1j |
2 |
1i |
3a |
2 |
2c |
29 |
F40199 |
1j |
1 |
1i |
3a |
2 |
1c |
22 |
Mean |
21.3 |
||||||
Individual eye irritation scores unwashed continued:
Animal No. |
Cornea |
Iris |
Conjunctivae |
Total Score* |
|||
A |
B |
C |
D |
E |
F |
||
96 h |
|||||||
F39914 |
1j |
1 |
0 |
3a |
2 |
0 |
15 |
F39937 |
1j |
1 |
0 |
3a |
1 |
0 |
13 |
F39939 |
0 |
0 |
0 |
3a |
1 |
0 |
8 |
F40197 |
1j |
1 |
0 |
3a |
1 |
0 |
13 |
F40198 |
1j |
1 |
1i |
3a |
2 |
0 |
20 |
F40199 |
1j |
1 |
1i |
3a |
2 |
0 |
20 |
Mean |
14.8 |
||||||
Day 7 |
|||||||
F39914 |
1n |
1 |
0 |
2a |
1 |
0 |
11 |
F39937 |
1j |
1 |
0 |
2 |
1 |
0 |
11 |
F39939 |
0 |
0 |
0 |
3a |
1 |
0 |
8 |
F40197 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40198 |
1j |
1 |
0 |
3a |
1 |
0 |
13 |
F40199 |
0 |
0 |
0 |
3a |
1 |
0 |
8 |
Mean |
9.2 |
||||||
Day 14 |
|||||||
F39914 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F39937 |
1 |
1 |
0 |
2 |
0 |
0 |
9 |
F39939 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40197 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40198 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
F40199 |
0 |
0 |
0 |
3a |
0 |
0 |
6 |
Mean |
4.5 |
||||||
Day 21 |
|||||||
F39914 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F39937 |
1j, n |
1 |
0 |
1 |
0 |
0 |
7 |
F39939 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40197 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40198 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40199 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
Mean |
2.5 |
||||||
A: Cornea - degree of opacity
B: Cornea - area of involvement
C: Iris - degreeof iridial irritation
D: Conjunctivae - redness
E: Conjunctivae - Chemosis
F: Conjunctivae - Discharge
*: total score = (A x B x 5)+ (C x 5) + [(D + E + F) x 2].
a: Petite haemorrhaging
b: Blanching
c: Clear discharge
i: Injected
j: Corneal epithelial peeling
n: Corneal neovascularization
t: No pain response after test material instillation
u: Excessive pawing at the treated eye after test material instillation
Table 4. Sodium fluorescein examination (unwashed):
Animal No. |
Sex |
Pre- initiation |
Observation period |
|||
72 h |
Day 7 |
Day 14 |
Day 21 |
|||
F39914 |
Female |
Neg |
Pos (20 %) |
Neg |
Neg |
Neg |
F39937 |
Female |
Neg |
Pos (15 %) |
Pos (10 %) |
Pos (10 %) |
Pos (< 5 %) |
F39939 |
Female |
Neg |
Neg |
Neg |
Neg |
Neg |
F40197 |
Male |
Neg |
Pos (20 %) |
Neg |
Neg |
Neg |
F40198 |
Male |
Neg |
Pos (30 %) |
Pos (15 %) |
Neg |
Neg |
F40199 |
Male |
Neg |
Pos (20 %) |
Neg |
Neg |
Neg |
Neg: Negative stain retention
Pos: Positive stain retention (area of cornea involved)
Table 5. Individual eye irritation scores for group 2 (washed):
Animal No. |
Cornea |
Iris |
Conjunctiva |
Total score* |
|||
A |
B |
C |
D |
E |
F |
||
1 h |
|||||||
F40202u |
1j |
1 |
1i |
2b |
2 |
2c |
22 |
F40201t |
0 |
0 |
1i |
2b |
2 |
2c |
17 |
F40200t |
0 |
0 |
1i |
2b |
1 |
1c |
13 |
Mean |
17.3 |
||||||
24 h |
|||||||
F40202 |
1j |
1 |
1i |
2b |
1 |
1c |
18 |
F40201 |
0 |
0 |
1i |
2b |
2 |
2c |
17 |
F40200 |
0 |
0 |
0 |
2b |
1 |
1c |
8 |
Mean |
14.3 |
||||||
48 h |
|||||||
F40202 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
F40201 |
0 |
0 |
0 |
2 |
1 |
1c |
8 |
F40200 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
Mean |
6.7 |
||||||
72 h |
|||||||
F40202 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
F40201 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
F40200 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
Mean |
6.0 |
||||||
96 h |
|||||||
F40202 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40201 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40200 |
0 |
0 |
0 |
2 |
1 |
0 |
6 |
Mean |
3.3 |
||||||
Day 7 |
|||||||
F40202 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40201 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
F40200 |
0 |
0 |
0 |
2 |
0 |
0 |
4 |
Mean |
2.7 |
||||||
Day 14 |
|||||||
F40202 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40201 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40200 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
Mean |
0.7 |
||||||
Day 21 |
|||||||
F40202 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40201 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F40200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
0.0 |
||||||
A: Cornea - degree of opacity
B: Cornea - area of involvement
C: Iris - degree of iridial irritation
D: Conjunctivae - redness
E: Conjunctivae - chemosis
F: Conjunctivae - discharge
*: Total score = (A x B x 5) + ( C x 5) + [(D + E + F) x 2]
b: Blanching
c: Clear discharge
i: Injected
j: Corneal epithelial peeling
u: Excessive pawing at the treated eye after instillation
t: No pain response after test material instillation
Table 6. Sodium fluorescein examination (washed):
Animal No. |
Sex |
Observation Period |
||||
Pre- initiation |
72 h |
Day 7 |
Day 14 |
Day 21 |
||
F40202 |
Male |
Neg |
Neg |
Neg |
Neg |
Neg |
F40201 |
Female |
Neg |
Neg |
Neg |
Neg |
Neg |
F40200 |
Female |
Neg |
Neg |
Neg |
Neg |
Neg |
Neg: Negative stain retention
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Skin irritation: The data available for trisodium orthophosphate suggests no classification according to Regulation (EC) No 1272/2008 (EU CLP). However, workplace observations have noted that under certain conditions (for example; humidity) local irritation when the material is placed in contact with the skin occurs and for that reason and in accordance with the hazard evaluation guidelines set out in the Guidance to Regulation (EC) No 1272/2008 trisodium phosphate is considered to be irritating to the skin (category 2).
Eye irritation: All available studies indicate that trisodium orthophosphate is irritating to the eyes and therefore classification as a category 2 eye irritant is proposed.
Respiratory irritation: Respiratory irritation has been noted in worker populations exposed to trisodium orthophosphate via the inhalation route and therefore a classification of STOT-SE category 3 for respiratory tract irritation is proposed.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
