Ammonium dihydrogenorthophosphate

Endpoint summary

Description of key information

Based on reliable in vivo studies with ammonium dihydrogenorthophosphate showing no or minimal irritation, it is concluded that that the substance is not irritating to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 h exposure under occlusive conditions

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80%

Duration of treatment / exposure:

24 h

Observation period:

9 days

Number of animals:

3 male and 3 female

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 48h time point was not reported, but based on the individual results no significant changes to the outcome of the study results are expected

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

other: 48h time point was not reported, but based on the individual results no significant changes to the outcome of the study results are expected.

	time	animal 1	animal 2	animal 3	animal 4	animal 5	animal 6
erythema	24 h	1	1	0	0	0	1
	72 h	0	0	0	0	0	0
	9 d	0	0	0	0	0	0
edema	24 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
	9 d	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to Regulation (EC) No.1272/2008

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

observation period was only 72 hours. A trend towards reversibility is visible.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL volume

Duration of treatment / exposure:

continuous

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 male and 3 female animals

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal: 1, 2, 3, 4, 5, 6

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

	time	animal 1	animal 2	animal 3	animal 4	animal 5	animal 6
corneal opacity	24 h	0	0	0	0	0	0
	48 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
	8 d	No data	No data	No data	No data	No data	No data
iris	24 h	0	0	0	0	0	0
	48 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
	8 d	No data	No data	No data	No data	No data	No data
conjunctiva erythema	24 h	2	2	2	2	2	2
	48 h	1	1	1	1	0	1
	72 h	0	0	1	1	0	0
	8 d	No data	No data	No data	No data	No data	No data

conjunctival edema was not observed.

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to Regulation (EC) No. 1272/2008

Conclusions:

Because reversibility of the findings is expected due to the trend obvious in the individual data, the substance is considered a non-irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a reliable skin irritation study performed comparable to OECD 404 guideline, ammonium dihydrogenorthophosphate does show some effects on the erythema, which are minimal and fully reversible within 72 hours. This was confirmed in supporting studies.

Eye irritation

In a reliable eye irritation study performed comparable to OECD 405 guideline, ammonium dihydrogenorthophosphate does not show any effects on the cornea and iris, but does show some limited effects on the conjunctiva (score 1 out of 3). These were decreasing in time, however not fully reversible within 72 hours (in 2 out of 6 animals). Because reversibility of the findings is expected due to the trend obvious in the individual data, the substance is considered a non-irritant. This was confirmed in supporting studies.

Justification for selection of skin irritation / corrosion endpoint:
One in vivo study on the substance is available.

Justification for selection of eye irritation endpoint:
One in vivo study on the substance is available.

Justification for classification or non-classification

Based on the available data, ammonium dihydrogenorthophosphate does not have to be classified for skin and eye irritation according to Regulation (EC) No. 1272/2008 on Classification & Labelling.