2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

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:

test procedure in accordance with national standard methods with acceptable restrictions

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:

other: US EPA. "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

EC Number:

280-479-2

EC Name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

Cas Number:

83547-95-9

Molecular formula:

C30H57O7PS3

IUPAC Name:

2-ethylhexyl 2-{[bis({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)phosphoryl]sulfanyl}acetate

Test material form:

liquid

Details on test material:

- Other: Trade name D 16-051

Specific details on test material used for the study:

TEST MATERIAL (as stated in study report): TK 12 184

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 312-187

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 deg C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact sites on each animal

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL per test site

Duration of treatment / exposure:

24 h

Observation period:

14 d

Number of animals:

3 males and 3 females

Details on study design:

Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnapper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

Skin reactions were scored using the Draize system.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 / 72 hr

Score:

3.8

Max. score:

5

Reversibility:

fully reversible within: 14 d

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

The erythema was greater than the site of application in all animals at the two first readings and in some after 72 hours and after 4 days. One animal had slightly ischaemic areas around the sites of application after 3-7 days. After 4 days slightly cracked skin was observed in 3/12 application sites. After 7 days on all animals a scale formation was seen which persisted in 5/12 sites up to 14 days.

Other effects:

Besides a slight sedation for two and frequent ventral recumbency for one day at the beginning of test no signs of intoxication were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under these test conditions TK 12 184 was found to cause a moderate irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 3.8. Changes were fully reversible within 14 days.