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
Study period:
Apr 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline conform study with restricted reporting

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
bw: 3.1 - 4.0 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
30 - 60 min post application
24 hours post application
48 hours post application
72 hours post application
7 d post application
14 d post application
21 d post application
Number of animals:
3
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 14 days
Irritant / corrosive response data:
Mean erythema score (all animals): 2.2
Mean edema score (all animals): 0.6

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
With reference the reported scores and the reported reversiblity within 21 days Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the skin (H 315: Causes skin irritation) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its skin irritant properties in 3 New Zealand rabbits. The study was performed according to OECD Guideline 404.

With reference the reported scores and the reported reversiblity within 21 days Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the skin (H 315: Causes skin irritation) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).