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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphoric acid, butyl ester, sodium salt
EC Number:
258-380-0
EC Name:
Phosphoric acid, butyl ester, sodium salt
Cas Number:
53126-67-3
Molecular formula:
C4H11O4P.Na
IUPAC Name:
Phosphoric acid, butyl ester, sodium salt
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Observation period:
Readings were made 24 and 72 hours after application
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal: #1, #3
Time point:
24 h
Score:
2
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks:
erythema score: 1
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal: #2, #4 - #6
Time point:
24 h
Score:
2
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks:
erythema score: 1
Irritation parameter:
erythema score
Remarks:
sore skin
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks:
erythema score: 1
Irritation parameter:
erythema score
Remarks:
sore skin
Basis:
animal: #2 - #6
Time point:
24 h
Score:
2
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks:
erythema score: 1
Irritation parameter:
erythema score
Remarks:
intact and sore skin
Basis:
animal: #1 - #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
intakt skin
Basis:
animal: #1 - #6
Time point:
72 h
Score:
1
Max. score:
8
Irritation parameter:
erythema score
Remarks:
sore skin
Basis:
animal: #1 - #6
Time point:
72 h
Score:
1
Max. score:
8
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal: #1, #3
Time point:
24 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal: #2, #4 - #6
Time point:
24 h
Score:
1
Max. score:
8
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
sore skin
Basis:
animal: #1, #3
Time point:
24 h
Score:
1
Max. score:
8
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
sore skin
Basis:
animal: #2, #5
Time point:
24 h
Score:
1
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks:
edema score: 1
Irritation parameter:
edema score
Remarks:
sore skin
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks:
edema score: 2
Irritation parameter:
edema score
Remarks:
sore skin
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks:
edema score: 72 h
Irritation parameter:
edema score
Remarks:
intact and sore skin
Basis:
animal: #1 - #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal: #1 - #6
Time point:
72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Remarks:
sore skin
Basis:
animal: #1, #3
Time point:
72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Remarks:
sore skin
Basis:
animal: #2, #5
Time point:
72 h
Score:
1
Max. score:
8
Irritation parameter:
edema score
Remarks:
sore skin
Basis:
animal: #4, #6
Time point:
72 h
Score:
2
Max. score:
8
Irritant / corrosive response data:
Erythema were mainly seen after 24 hours. Based on the applied scoring system, the substance was found to be mildly irritating to skin.

Applicant's summary and conclusion

Interpretation of results:
other: Due to the limited documentation the study cannot be used for classification.
Conclusions:
Signs of mild irritation were seen in the study.
Executive summary:

A study was performed to assess the irritation of the test material to the skin of six rabbits. As a result, erythema and edema were seen in all animals. Erythema were not reversible within 72 hours. Based on the applied scoring system, the substance was found to be mildly irritating to skin, but due to the limited documentation no conclusion can be drawn on classification.