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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(24 h exposure under occlusive conditions)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #6
Time point:
other: 24, 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: #3, #4, #5
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1-#6 (all animals)
Time point:
other: 24, 72 h
Score:
0
Max. score:
4

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.