Triethyl phosphonoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 5 October 1992 to 4 November 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted in compliance with international standard guidelines under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 hour exposure period, no certificate of analysis

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethyl phosphonoacetate

EC Number:

212-757-6

EC Name:

Triethyl phosphonoacetate

Cas Number:

867-13-0

Molecular formula:

C8H17O5P

IUPAC Name:

ethyl 2-(diethoxyphosphoryl)acetate

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: Ace Animals
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.4 kg
- Fasting period before study: none
- Housing: 2/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but conditions not specified
- Humidity (%): no data
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: from 6 October 1992 to 9 October 1992

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact clipped skin and abraded clipped skin

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml applied to 2 sites (abraded and intact)

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: 2.5 cm²
- Type of wrap if used: the treated sites were covered with gauze patches which were secured with adhesive tape. The torso was wrapped with plastic which was secured with adhesive tape.

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

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Reversibility:

fully reversible within: 3 d

Remarks on result:

other: 24 and 72h mean

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Reversibility:

fully reversible within: 3 d

Remarks on result:

other: 24 and 72h mean

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.5

Reversibility:

fully reversible within: 3 d

Remarks on result:

other: 24 and 72h mean

Results 4

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.5

Reversibility:

fully reversible within: 3 d

Remarks on result:

other: 24 and 72h mean

Results 5

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.5

Reversibility:

fully reversible within: 3 d

Remarks on result:

other: 24 and 72h mean

Results 6

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Reversibility:

fully reversible within: 3 d

Remarks on result:

other: 24 and 72h mean

Results 9

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.5

Reversibility:

fully reversible within: 3 d

Remarks on result:

other: 24 and 72h mean

Results 10

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

0.54

Max. score:

0.83

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Erythema, absent to well-defined at 24 hours after test article application, was absent at 72 hours.
Edema, absent to slight at 24 hours after test article application, was absent at 72 hours.

Other effects:

Diarrhoea and ano-genital soiling, noted in one animal.

Any other information on results incl. tables

Table 7.3.1/1 :Irritation scores

 

	Rabbit No.						Mean Score
	D4667	D4668	D4669	D4670	D4671	D4672
Erythema/Eschar
Intact 24 h	1	1	1	1	1	0	0.83
Intact 72 h	0	0	0	0	0	0	0.00
Mean (intact skin) 24-72h	0.5	0.5	0.5	0.5	0.5	0.0	0.42
Abraded 24 h	0	1	2	1	1	0	0.83
Abraded 72 h	0	0	0	0	0	0	0.00
Oedema
Intact 24 h	0	1	1	0	0	0	0.33
Intact 72 h	0	0	0	0	0	0	0.00
Mean (intact skin) 24-72h	0.0	0.5	0.5	0.0	0.0	0.0	0.17
Abraded 24 h	0	0	1	0	0	0	0.17
Abraded 72 h	0	0	0	0	0	-	0.00
Sum of mean scores							2.16
PDII(sum of mean scores/4)							0.54

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was only slightly irritating to the skin. No classification is required according to the criteria of Regulation (EC) 1272/2008 (CLP).

Executive summary:

In a GLP-compliant skin irritation study performed similarly to the OECD 404 Guideline, six male New Zealand white rabbits were dosed dermally with undilued test materail. 0.5 ml of the test substance was applied to 1 intact and 1 abraded site on the clipped back for a total of 1.0 ml per rabbit. The sites were occluded for 24 hours. Those exposure conditions correspond to a worst case approach as the test guidance recommends an exposure under semi-occlusive patch and for 4h. The skin reactions were evaluated by the Draize technique at 24 and 72 hours after the test item application. Body weights were recorded pre-test. The Primary irritation Index was calculated.

Erythema, absent to well-defined at 24 hours after test article application, was absent at 72 hours. Edema, absent to slight at 24 hours after test article application, was absent at 72 hours. Diarrhoea and ano-genital soiling, noted in one animal, was the only abnormal systemic sign observed during the study.

 

The Primary Irritation Index was 0.54.

 

The mean individual scores calculated within 2 scoring times (24 and 72 hrs) for the unabraded skin were 0.5/0.5/0.5/0.5/0.5/0.0 for erythema and 0.0/0.5/0.5/0.0/0.0/0.0 for edema.

 

Under the test conditions, the test item is not classified as skin irritant when applied topically to rabbits according to the criteria of the Regulation (EC) 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for the skin irritation endpoint.