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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
Study period:
from 2007-11-22 till 2007-12-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2004/73/EG, B.4
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
483-300-8
EC Name:
-
Cas Number:
99580-93-5
Molecular formula:
Hill formula: C3H13N2O3P CAS formula: C2H8N2.CH5O3P
IUPAC Name:
1,2-Ethanediamine methylphosphonate
Test material form:
solid: bulk
Details on test material:
Batch number: FEB 278-810

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
rbt, New Zealand White Hsd If:HZW

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
other: aqua ad inject.
Controls:
other: The untreated other side served as control.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
none
Other effects:
No effects observed.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item showed no irritant/corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.