Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

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

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

Constituent 1
Chemical structure
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 dihydrogen phosphate
Constituent 2
Reference substance name:
Monoammonium phosphate (MAP)
IUPAC Name:
Monoammonium phosphate (MAP)
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Monoammoniumphosphate, Härter 26 Pulver
- No further details provided

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 days
Number of animals:
3 male and 3 female

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified according to Regulation (EC) No.1272/2008