Phthalic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phthalic acid

EC Number:

201-873-2

EC Name:

Phthalic acid

Cas Number:

88-99-3

Molecular formula:

C8H6O4

IUPAC Name:

benzene-1,2-dicarboxylic acid

Details on test material:

Molar Mass: 166.13 g/mol, Content of test item*: 95 %, the dosing was based on the test item (used as 100%).
*due to product information given by the sponsor.

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Preparation of test site:

other: On the day before the test, the fur was shorn on the right and left side from the dorso-lateral area of the trunk of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healthy and intact skin were used.

Controls:

other: The surrounding untreated skin served as control.

Duration of treatment / exposure:

Due to a possible irritant potential of the test substance, in the first step only one animal was used and three test patches were applied successively to this animal, as described above. The first patch was removed after three minutes. As no serious skin reactions were observed, the second patch was applied and removed after one hour. At this stage the observations indicated that with respect to animal welfare the exposure can be allowed to extend to four hours, therefore the third patch was applied and removed after four hours and the responses were graded one hour later.
The test was completed using two additional animals, exposed for four hours.

Observation period:

Based on most recent guidelines the dermal irritation was scored approximately at 1, 24, 48 and 72 hours after patch removal. If no irritation indices were observed, after 72 h, the study was finished. If dermal irritation was observed, animals were monitored usually on day 7 and 14 after patch removal until the changes had completely subsided, however for not more than 14 days after application.

Number of animals:

Three animals were used for the study.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1d

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Summary of Irritant Effects (Score)

Animal	Effect	24 h	48 h	72h	Mean scores	Response	Reversible (days)
1	Erythema (redness) and eschar formation	0	0	0	0.0	-	1*
	Oedema formation	0	0	0	0.0	-	na
2	Erythema (redness) and eschar formation	0	0	0	0.0	-	na
	Oedema formation	0	0	0	0.0	-	na
3	Erythema (redness) and eschar formation	0	0	0	0.0	-	1
	Oedema formation	0	0	0	0.0	-	na

no positive response : mean scores <2 = -

positive response : mean scores , >2 = +

na: not applicable

* : in respect of the result 1 h post application

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The irritant / corrosive potential of the test substance was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002 and the EEC Directive No. 440/2008 Part B - Method BA. According to classification criteria the test substance is not an irritant to the skin. There were no systemic intolerance reactions.