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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically defensible or guideline method was used, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Guideline:
other: US Federal Hazardous Sustances Act
Deviations:
not specified
Remarks:
for further details, see below
Principles of method if other than guideline:
0.5 g applied as finely ground sample moistened with water
Study was conduced according to Federal Hazardous Substance Act
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Carboxylic acids, di-, C4-6
EC Number:
271-678-5
EC Name:
Carboxylic acids, di-, C4-6
Cas Number:
68603-87-2
Molecular formula:
C5H8O4, C4H6O4, C6H10O4
IUPAC Name:
Carboxylic acids, C4-6 di-
Details on test material:
Dibasic Acid Concentrate; 0.5 g applied as finely ground sample moistened with water

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - <= 2
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0 - <= 2
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
7 days
Other effects:
Slight scabbing at lines of abrasions.

Any other information on results incl. tables

The individual scores of 3 animals were shown; the other three treated animals show comparable effects.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
not irritating
Executive summary:

In a skin irritation study according to the US Federal Hazardous Substance Act with limited documentation 500 mg of a dicarboxylic acid mixture moistened with water was applied to the shaved intact or abraded skin of six rabbits, respectively, for 24 h. Slight scabbing at line of abrasion was observed. Mean scores for erythema or oedema after 24, 48 and 72 were 1.2 or 0.43, respectively. All effects were reversible by day 7.