Reaction mass of Ammonium dihydrogenorthophosphate and diammonium hydrogenorthophosphate.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented near-guideline study but observation period was only 72 hours. A trend towards reversibility is visible.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Monoammonium phosphate (MAP)

IUPAC Name:

Monoammonium phosphate (MAP)

Details on test material:

- Name of test material (as cited in study report): Monomammoniumphosphate, Härter 26 Pulver

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.05

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: reversibility not determinable because of limited observation time (72 h)

Any other information on results incl. tables

 

	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
	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	0	0	0	0	0	0
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.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Because reversibility of the findings is expected due to the trend obvious in the individual data, the substance is slighlty irritating for eyes and is considered as not classified for this endpoint.