Bis(2,4,4-trimethylpentyl)phosphinic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1982-11-30 to 1982-03-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP guideline study with some restrictions: no certificate of analysis, 24h exposure period instead of 4h recommended in the guideline (worst case condition), occlusive patch (worst case condition), only two observation time (24h and 72h), no assessment of the reversibility of the effects.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: no certificate of analysis, 24h exposure period instead of 4h recommended in the guideline (worst case condition), occlusive patch (worst case condition), only two observation times (24h and 72h), no assessment of the reversibility of the effects.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2,4,4-trimethylpentyl)phosphinic acid

EC Number:

280-445-7

EC Name:

Bis(2,4,4-trimethylpentyl)phosphinic acid

Cas Number:

83411-71-6

Molecular formula:

C16H35O2P

IUPAC Name:

bis(2,4,4-trimethylpentyl)phosphinic acid

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hare Haven Rabbitry, Middleboro, MA, USA
- Age at study initiation: 10 to 13 weeks
- Weight at study initiation: 2.3 to 2.7 kg
- Housing: no data
- Diet: Charles River rabbit formula, lot #W2300
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 74 ± 5 °F
- Humidity: 50 ± 15 %
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded on left side, unabraded (shaved) on right side

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 hours after patch removal

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: trunk. Two independent sites were exposed to the test substance (Site 1 and 2) on each flank of the animals: 2 sites on abraded skin (left side) and 2 sites on unabraded skin (right side)
- % coverage: no data
- Type of wrap if used: the test substance was introduced under a "1 x 1" gauze pad previsously secured to the test site with surgical tape. the animals were wrapped with an impervious covering (plastic wrap) and then stockinette to prevent removal of the patches by the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: the scores were calculated at 24 and 72h after the patch removal according to the Draize scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

abraded skin-Site 1 and Site 2

Basis:

other: 2 out of 6

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Remarks:

abraded skin-Site 1 and Site 2

Basis:

other: 2 out of 6

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Remarks:

abraded skin-Site 1 and Site 2

Basis:

other: 1 out of 6

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

erythema score

Remarks:

abraded skin-Site 1 and Site 2

Basis:

other: 1 out of 6

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 5

Irritation parameter:

edema score

Remarks:

abraded skin-Site 1

Basis:

other: 3 out of 6

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 6

Irritation parameter:

edema score

Remarks:

abraded skin-Site 1 and Site 2

Basis:

other: 2 out of 6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 7

Irritation parameter:

edema score

Remarks:

abraded skin-Site 1 and Site 2

Basis:

other: 1 out of 6

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Results 8

Irritation parameter:

edema score

Remarks:

abraded skin-Site 2

Basis:

other: 1 out of 6

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritant / corrosive response data:

The test substance caused erythema and edema to the abraded and intact test sites of all of the rabbits at the 24h observation period. By the 72h observation period, all erythema and edema subsided completely in one rabbit. In three other rabbits all erythema subsided. Of the remaining two rabbits, one displayed erythema and edema on the abraded test sites and edema on the intact sites. The other animal displayed erythema and edema on the abraded and intact test sites at the 72 h observation period. No irritation was observed on the control sites. The primary irritation score was 2.2.

Other effects:

no other effects

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on unabraded skin

Score at time point / Reversibility	Erythema		Edema
	Max. score: 4		Max. score: 4
	Site 1	Site 2	Site 1	Site 2
24 h	1/1/1/2/2/1	1/1/1/2/2/1	2/1/2/1/2/2	2/1/2/1/2/2
72 h	0/0/0/0/0/1	0/0/0/0/0/1	1/1/0/1/1/1	1/1/0/1/1/1
Average 24h and 72h	0.5/0.5/0.5/1.0/1.0/1.0		1.5/1.0/1.0/1.0/1.5/1.5
Reversibility	No data		No data

 

Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on abraded skin

Score at time point / Reversibility	Erythema		Edema
	Max. score: 4		Max. score: 4
	Site 1	Site 2	Site 1	Site 2
24 h	1/2/1/2/3/2	1/2/1/2/3/2	2/1/2/1/2/2	2/1/2/1/2/3
72 h	0/0/0/0/1/1	0/0/0/0/1/1	1/1/0/1/1/1	1/1/0/1/1/1
Average 24h and 72h	0.5/1.0/0.5/1.0/2.0/1.5		1.5/1.0/1.0/1.0/1.5/1.8
Reversibility	No data		No data

 

Applicant's summary and conclusion

Interpretation of results:

other: not classified as a skin irritant according to the CLP Regulation (EC) No.1272/2008

Conclusions:

Non-skin irritant

Executive summary:

In a dermal irritation study performed similarly to the OECD guideline No. 404, 6 male New Zealand White rabbits, were dermally exposed to 0.5 ml of undiluted to the test material.

Prior to the topical application, the skin of the rabbit was prepared with an electric clipper to remove the hair. After clipping, the left side of the animal was prepared by making epidermal abrasions, while the right site remained intact (clipped but unabraded). The test substance was then applied on the skin (abraded or not) on two different application sites (site 1 and 2). Then the test siteswere covered with an occlusive dressing for 24 hours. Those exposure conditions correspond to a worst case approach as the test guidance recommends an exposure under semi-occlusive patch and for4h.Skin irritation was assessed and scored according to the Draize scale at 24 and 72 hrs after the topical application of the test patch.  

The mean individual scores calculated within 2 scoring times (24 and 72 hrs) for the unabraded skin were 0.5/0.5/0.5/1.0/1.0/1.0 for erythema and 1.5/1.0/1.0/1.0/1.5/1.5 for edema. The reversibility of the effects was not assessed as the observation of the skin and the scoring ended 72hrs after the application of the test item. However, on the intact skin the scores observed at 72hrs on the intact skin of all animals are low (equal to 1) or equal to 0 (no more skin effect). Moreover between 24 and 72hrs time scoring , the scores for erythema and edema were decreasing which is in favor with the reversibility of the irritant effects.

Under the test conditions, and considering the mean scores (24/48/72h) the test is not considered as skin irritant when applied topically to rabbits.