Phosphoric acid, 2-ethylhexyl ester, sodium salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2019-03-12 to 2019-03-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was stopped due to animal welfare reasons.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

9 October 2017

Deviations:

no

Remarks:

The study was terminated after treating one animal due to animal welfare reasons.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Council Regulation (EC) No 440/2008

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, 2-ethylhexyl ester, sodium salt

EC Number:

269-044-8

EC Name:

Phosphoric acid, 2-ethylhexyl ester, sodium salt

Cas Number:

68186-64-1

Molecular formula:

C8 H18 O . x H3 O4 P . x Na

IUPAC Name:

.

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adult rats
- Weight at study initiation: between 200 g and 300 g
- Fasting period before study: no
- Housing: during acclimatization: 3 animals/cage, During the exposition the animal was housed individually.
- Diet: ad libitum ssniff® SM R/M-Z+H complete diet (ssniff Spezialdiäten GmbH, D-59494 Soest Germany)
- Water: tap water ad libitum)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): above 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: approximately 10 % area of the total body surface
- Type of wrap: Sterile gauze pads were placed on the skin of the rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi-occlusive plastic wrap for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24

Duration of exposure:

24 h

Doses:

200 mg/kg bw

No. of animals per sex per dose:

1 (range finding in one female)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: Due to animal welfare reasons, the animal had to be sacrificed on Day 2 (treatment Day was Day 0).
- Frequency of observations and weighing: the animal was observed 30 minutes, 2 h, 4 h and 6 h after dosing, and then daily thereafter

Statistics:

not applicable

Results and discussion

Preliminary study:

The test item was applied in original form and left in contact with the skin for a 24 hours period. The observation period was three days (treatment day as Day 0 and posttreatment period as Day 1 and Day 2). The in-life phase was terminated on Day 2 and the study was stopped, because unexpected corrosive signs were found on the treated skin surface. Moderate to severe erythema and other signs as whitish colouration were observed on Day 1, 1 hour after the patch removal. Severe erythema, open wound, crust and necrosis were detected on Day 2. No death and any systemic toxic sign were found. The body weight loss (approx. 4.2%) was observed between the treatment day and Day 2. External macroscopic changes as open wound, crust and necrosis were found on the treated area of the animal.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Remarks on result:

not determinable

Mortality:

not observed

Clinical signs:

other: No signs of systemic toxicity were observed. Local signs of corrosivity were found on the treated skin surface.

Gross pathology:

External macroscopic changes as open wound, crust and necrosis were found on the treated area of the animal.

Any other information on results incl. tables

Table 1:Findings in the treated animal

Dose mg/kg	Animal number	Body weight (g)		Death	Systemic clinical signs				Local signs
		Day 0	Day 2		30 min	2 h	4 h	6 h	Day 1	Day 2
200	4142	215	206	*	—	—	—	—	R3;Wc	R4;W;P;N

Remarks:   * = Humanely killing

                 — = No data

                 R3 = Moderate erythema

                 R4 = Severe erythema

                 Wc = Whitish colouration

                 W = Open wound

                 P = Crust

                 N = Necrosis

 

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

As the study had to be terminated two days after treating one animal, no LD50 value could be determined.

Executive summary:

The objective of the study was to assess the toxicity of test item when administered in a single dermal dose to rats at one or more defined dose levels.At first, the range-finding study was performed in one female Han:WISTrat. The starting dose was 200 mg/kg bw. The test item was applied in original form and left in contact with the skin for a 24 hours period. The observation period was three days (treatment day as Day 0 and post treatment period as Day 1 and Day 2). The in-life phase was terminated on Day 2 and the study was stopped, because unexpected corrosive signs were found on the treated skin surface. Moderate to severe erythema and other sign as whitish colouration were observed on Day 1, 1 hour after the patch removal. Severe erythema, open wound, crust and necrosis were detected on Day 2. No death and any systemic toxic sign were found. The body weight loss (approx. 4.2%) was observed between the treatment day and Day 2. External macroscopic changes as open wound, crust and necrosis were found on the treated area of the animal.The test item could not be classified into any toxicity category for acute dermal toxicity.