Diallyl phthalate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Date of Study Report: August 9, 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: Exposure duration, testing included abraded skin, Scoring following other criterias

Principles of method if other than guideline:

The exposure period was 24 h instead of 4 h. Post-dose observations were made up to 7 d instead of 14 d. Part of the shaven skin was abraded, which is not according to OECD guideline 404, which says:"Care should be taken to avoid abrading the skin."

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diallyl phthalate

EC Number:

205-016-3

EC Name:

Diallyl phthalate

Cas Number:

131-17-9

Molecular formula:

C14H14O4

IUPAC Name:

1,2-bis(prop-2-en-1-yl) benzene-1,2-dicarboxylate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Diallyl Phthalate (DAP)
- Analytical purity:
- Other:
- Identified as No. C-8013-3)
- Specific gravity: 1.117-1.123 at 20°C/20°C
- Solubility in methanol: 1 cm³ in 5 cm³, clear-only slightly turbid
- Acidity as acetic acid, % by weight: 0.1 max
- Moisture (Karl Fischer), %: 0.1 max
- Color APHA Pt-Co: 90 max
- Odor: mild

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

Test was conducted on 6 adult albino rabbits selected from healthy, acclimated animals.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Each rabbit: shaven skin, partly abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL or 0.5 g

Duration of treatment / exposure:

24 hour(s)

Observation period:

24, 72 h and 7 d

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1 inch x 1 inch
- Each rabbit treated with a patch on shaven skin and on abraded skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated
- Time after start of exposure: Patches were removed after 24 hrs

OBSERVATIONS:
- 24 h, 72 h and 7 d after start of the exposure.

SCORING SYSTEM: Draize Scoring Criteria

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

< 1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

probability of weak irritation

Any other information on results incl. tables

Table: Primary Skin Irritation Scores of Rabbits dosed with Diallyl phthalate (According to Draize Scoring Criteria)

Findings	Exposure Time	Exposure Unit (Value)
		Rabbit No.
		1	2	3	4	5	6
Erythema and eschar formation:
Intact Skin	24 hrs	2	2	2	2	2	2
Intact Skin	72 hrs	1	1	1	1	1	1
Intact Skin	7 days	1	1	0	1	1	1
Abraded skin	24 hrs	2	2	2	2	2	2
Abraded skin	72 hrs	1	1	2	1	1	1
Abraded skin	7 days	1	1	1	1	1	1
Subtotal
Edema formation:
Intact Skin	24 hrs	1	1	1	1	1	1
Intact Skin	72 hrs	1	1	0	0	1	0
Intact Skin	7 days	1	0	0	0	0	0
Abraded skin	24 hrs	1	1	1	1	1	1
Abraded skin	72 hrs	1	1	0	0	0	1
Abraded skin	7 days	0	0	0	0	0	0
Subtotal		4	4	2	2	3	3
Total		10	10	9	8	9	9
Score		2.50	2.50	2.25	2.00	2.25	2.25
Average		2.29

- 7 -Day values not included in calculating the score.

Erythema and edema were observed in the intact and abraded skin of all six animals. Erythema cleared in the intact skin of one animal. Edema cleared in the intact skin of five animals, and abraded skin of all six animals during the 7-day observation period.

Draize Scoring Criteria:

- Primary Skin Irritation Indexes of less than 2.0 are mild irritants.

- Primary Skin Irritation Indexes of 2.0 to 5.0 are moderate irritants.

- Primary Skin Irritation indexes of greater than 5.0 are severe irritants.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Primary skin irritation testing of DAP at a dose of 0.5g by FDRL during 24 h, showed the sample to be moderately irritant up to 72 h after the start of exposure (within the range of 2.0 to 5.0) and decreased to mildly irritant after 7 days post-exposure. Hence, based on the fact that exposure duration was 6 times longer than that prescribed by OECD Guideline 404, and the scoring decreased to mildly irritant within 7 days of exposure, the final conclusion is that DAP can be expected to be only slightly irritant, when evaluated according to OECD guideline 404.

Executive summary:

On the basis of the data presented herein, the test material, FMC Corporation D.A.P. (1 Qt. Net Wt.) C-8013-3; is a moderate irritant to the rabbit skin.