Reaction products of sulphuric acid, rock phosphate and humic acids, potassium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 The rationale to use data from individual constituents and components of the complex is explained in chapter 1 of the CSR and in the adjacent "read-across document".

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(24 h exposure under occlusive conditions)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium dihydrogenorthophosphate

EC Number:

231-764-5

EC Name:

Ammonium dihydrogenorthophosphate

Cas Number:

7722-76-1

Molecular formula:

H3N.H3O4P

IUPAC Name:

ammonium dihydrogenorthophosphate

Constituent 2

Reference substance name:

Monoammonium phosphate

IUPAC Name:

Monoammonium phosphate

Details on test material:

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

Test animals

Species:

rabbit

Strain:

Vienna White

Test system

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 d

Number of animals:

3 male and 3 female

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animle #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 6

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #6

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 9

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 10

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 11

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Results 12

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

no score after 48h assessed

Any other information on results incl. tables

Individual animal data:

	time point	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

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not irritating to skin.

Executive summary:

The skin irritation potential of the test substance was tested in 6 rabbits exposed to 0.5 g test item in water (80%) for 24 h.

3/6 animals had an erythema score of 0 at the 24-h-reading and the other 3/6 animals had an erythema score of 1 at the 24-h-reading.

These effects were fully reversible as 6/6 animals showed an erythema score of 0 at the 72-h-reading and at the 9-d-reading. The edema score was zero in all animals at any observation time point (24 h, 72 h, 9 d). Therefore, the test item is not irritating to skin.