Reaction products of triphenyl phosphite and isodecanol (1:2)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Report in compliance with current (1981) GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Remarks:

The report in compliance with current (1981) GLPs.

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of triphenyl phosphite and isodecanol (1:2)

EC Number:

701-374-4

Cas Number:

25550-98-5

Molecular formula:

C26H47O3P

IUPAC Name:

Reaction products of triphenyl phosphite and isodecanol (1:2)

Constituent 2

Reference substance name:

Phenyldiisodecyl Phosphite

IUPAC Name:

Phenyldiisodecyl Phosphite

Details on test material:

- Name of test material (as cited in study report): Phenyldiisodecyl Phosphite
- Substance type:
- Physical state: Liquid
- Composition of test material, percentage of components: 10% w/v suspension in Mineral Spirits
- Lot/batch No.: #PDDP-002-03240A

Test animals

Species:

guinea pig

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: between 300 and 400 grams
- Sex: male

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: suspension in Mineral Spirits

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): 10% w/v


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): 90%

Duration of treatment / exposure:

After 24 hour contact period patch removed; 1 day rest; second fresh patch applied to same skin site. Sequence repeated for total of 10 applications. After 10 applications animals rested for 2 weeks. At termination of rest period, challenge application was put on skin sites differing from the original test sites for 24 hours.

Observation period:

24 hours after each induction stage application and 24 and 48 hours after the challenge (re-test) application, the sites were examined for irritation.

Number of animals:

10

Details on study design:

TEST SITE
- Area of exposure: trunk
- % coverage:
- Type of wrap if used: impervious material


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hrs

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 hrs

Score:

0.6

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

All test subjects displayed slight erythema after each 24 hour exposure period (both repeat exposures and 24 hour challenge exposures). Six out of ten subjects showed slight erythema after the 48 hour challenge exposure. No subjects displayed signs of edema after any exposure.

Any other information on results incl. tables

Guinea Pig Contact Dermal Irritation/Sensitization Study

MALES

		Reading After Application Number											Challenge
Guinea Pig No.		1	2	3	4	5	6	7	8	9	10		24 Hours	48 Hours
1	Erythema	1	1	1	1	1	1	1	1	1	1		1	1
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
2	Erythema	1	1	1	1	1	1	1	1	1	1		1	0
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
3	Erythema	1	1	1	1	1	1	1	1	1	1		1	1
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
4	Erythema	1	1	1	1	1	1	1	1	1	1		1	1
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
5	Erythema	1	1	1	1	1	1	1	1	1	1		1	0
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
6	Erythema	1	1	1	1	1	1	1	1	1	1		1	0
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
7	Erythema	1	1	1	1	1	1	1	1	1	1		1	1
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
8	Erythema	1	1	1	1	1	1	1	1	1	1		1	1
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
9	Erythema	1	1	1	1	1	1	1	1	1	1		1	0
	Edema	0	0	0	0	0	0	0	0	0	0		0	0
10	Erythema	1	1	1	1	1	1	1	1	1	1		1	1
	Edema	0	0	0	0	0	0	0	0	0	0		0	0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The material appears to be a mild primary skin irritant when tested as a 10% w/v suspension in mineral spirits. It does not appear to be a fatiguing agent or a sensitizing agent in the albino guinea pig.

Executive summary:

A group of male albino guinea pigs were used to assess the contact dermal irritation/sensitization potential of phenyldiisodecyl phosphite (CAS # 25550 -98 -5) prepared as a 10% w/v suspension in mineral spirits. A 0.5mL portion of the material was applied to intact skin test sites and wrapped with gauze and impervious material. The wrap was left on for 24 hours, then taken off for the animals to rest for 24 hours. The material was then applied to the same area and re-wrapped; this sequence was repeated 10 times followed by a 2 week rest period. At the termination of the rest period, a challenge application was put on skin sites different than the original test sites. The challege application remained for 24 hours.

Twenty-four hours after each induction stage application and 24 and 48 hours after teh challenge application, the sites were examined for irritation using the Draize method of scoring to grade reactions.

When tested as a 10% w/v suspension in mineral spirits, the material appears to be a mild primary skin irritant . It does not appear to be a fatiguing agent or a sensitizing agent in the albino guinea pig.