Isodecyl diphenyl phosphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

In vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 15, 1980 - July 17, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study similar to OECD Guideline 404. QA. Environmental conditions not reported. Acceptable basic data.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

3 male and female rabbits used; 4 skin sites (intact and abraded)/animal; observation time: 4, 24, and 48 hours

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

180-415 (C9889-147)

IUPAC Name:

180-415 (C9889-147)

Constituent 2

Reference substance name:

Isodecyl diphenyl phosphate

EC Number:

249-828-6

EC Name:

Isodecyl diphenyl phosphate

Cas Number:

29761-21-5

Molecular formula:

C22H31O4P

IUPAC Name:

isodecyl diphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): 180-415
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually, in suspended wire bottom galvanize steel gages
- Diet: Purina rabbit chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: one week plus

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

4, 24, and 48 hours

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: 1" x 1"/site
- coverage: 4 skin sites/animal
- Type of wrap if used: surgical gauze patch, secured in place with strips of adhesive tape and wrapped with polyethylene film.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: The scoring criteria as described by Draize. Erythema and Eschar formation / Edema formation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

and eschar formation

Basis:

mean

Remarks:

6 animals: 4 skin sites/animal

Time point:

other: 4, 24 and 48 hours

Score:

ca. 0.84

Max. score:

1

Reversibility:

not fully reversible within: 48 hours

Remarks on result:

other: intact and abraded skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals: 4 skin sites/animal

Time point:

other: 4, 24 and 48 hours

Score:

ca. 0.22

Max. score:

1

Reversibility:

not fully reversible within: 48 hours

Remarks on result:

other: intact and abraded skin

Irritant / corrosive response data:

Erythema and edema formation scores in tables. There were no signs of tissue destruction (ulceration or necrosis), or other dermal irritation or defects present on any test site at any of the observation times. The test material is not irritant or corrosive to the skin when treated on the intact and abraded skin of albino rabbits.

Any other information on results incl. tables

Scoring table: Erythema & Eschar formation, intact and abraded skin

Overall mean: 0.84 

	Rabbit number and sex
	LA intact skin						Mean		RA abraded skin						Mean
	1M	2M	3M	4F	5F	6F			1M	2M	3M	4F	5F	6F
4-hour observation	1	1	1	1	1	1	1.00		1	1	1	1	1	1	1.00
24 hour observation	1	1	1	1	1	1	1.00		1	1	1	1	1	1	1.00
48 hour observation	0	0	1	1	1	0	0.50		1	0	1	1	1	0	0.67
	LP intact skin								RP abraded skin
	1M	2M	3M	4F	5F	6F			1M	2M	3M	4F	5F	6F
4-hour observation	1	1	1	1	1	1	1.00		1	1	1	1	1	1	1.00
24 hour observation	1	1	1	1	1	0	0.83		1	1	1	1	1	1	1.00
48 hour observation	0	0	1	1	1	0	0.50		1	0	1	1	1	0	0.67

LA          Left anterior test site – intact test site

RA         Right anterior test site – abraded test site

LP          Left posterior test site – intact test site

RP        Right posterior test site – abraded test site

Scoring table: Edema formation, intact and abraded skin

Overall mean: 0.22

	Rabbit number and sex
	LA intact skin						Mean		RA abraded skin						Mean
	1M	2M	3M	4F	5F	6F			1M	2M	3M	4F	5F	6F
4-hour observation	0	0	0	0	0	0	0.00		0	1	1	1	1	1	0.83
24 hour observation	0	0	0	0	0	0	0.00		1	1	0	0	1	0	0.50
48 hour observation	0	0	0	0	0	0	0.00		0	0	0	0	0	0	0.00
	LP intact skin								RP abraded skin
	1M	2M	3M	4F	5F	6F			1M	2M	3M	4F	5F	6F
4-hour observation	0	0	0	0	0	0	0.00		0	1	1	0	1	0	0.50
24 hour observation	0	0	0	0	1	0	0.17		1	1	0	0	1	0	0.50
48 hour observation	0	0	0	0	0	0	0.00		1	0	0	0	0	0	0.17

LA          Left anterior test site – intact test site

RA         Right anterior test site – abraded test site

LP          Left posterior test site – intact test site

RP        Right posterior test site – abraded test site

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is not irritant or corrosive to the skin when treated on the intact and abraded skin of albino rabbits. The average mean scores calculated from the numerical values given to the skin irritation observed at the 4, 24, and 48 hour examinations were 0.84 for erythema and 0.22 for edema. Based on these results and according to EU criteria the material was considered not irritating and the substance does not have to be classified according to the classification criteria outlined in 67/548/EEC and 1272/2008.

Executive summary:

A skin irritation and corrosion study was conducted, similar to OECD guideline 404, on 3 male and 3 female albino rabbits using the test material 180-415. There were 2 intact skin test sites and 2 abraded skin test sites per rabbit. Each test site was treated with 0.5 ml of actual undiluted test material and was occluded for 4 hours. Observations for dermal irritation or defects were made at 4, 24, and 48 hours after application of the tests material and reactions at the contact sites were graded. There were no signs of tissue destruction (ulceration or necrosis), or other dermal irritation or defects present on any test site at any of the observation times. The test material is not irritant or corrosive to the skin when treated on the intact and abraded skin of albino rabbits. The average mean scores calculated from the numerical values given to the skin irritation observed at the 4, 24, and 48 hour examinations were 0.84 for erythema and 0.22 for edema. Based on these results and according to EU criteria the material was considered not irritating and the substance does not have to be classified according to the classification criteria outlined in 67/548/EEC and 1272/2008.