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

Eye irritation

Administrative data

Endpoint:

eye 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:

according to guideline

Guideline:

other: US EPA) "Primary eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: in house
- 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

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

14 d

Number of animals or in vitro replicates:

6 animals - unwashed
3 animals - washed

Details on study design:

The test material was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 9 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, 7, 10 and 14 and was scored for each individual rabbit (Draize scoring system).

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Score:

6

Max. score:

20

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Unrinsed eyes:
Besides a slight irritation of the cornea (Grade 1) in one animal after 24 hours no irritation of cornea or iris was observed. Conjunctival irritation returned to normal within 14 days. The maximum mean score of 6.0 was observed after 24 hours. Grade 2 conjunctival irritation occurred in a single unwashed eye and a single washed eye at 24 hours only.
Rinsed eyes;
No irritation of cornea or iris was seen. Conjunctival irritation returned to normal within 14 days. The maximum mean score of 3.3 was observed after 24 hours.

Other effects:

A slight sedation was observed in some animals for 7 days, thereafter only one animal was slightly sedated until day 13.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not an eye irritant by GHS criteria

Conclusions:

Under these standard test conditions, TK 12 184 was mildly irritating to the rabbit eye, producing a maximum mean irritation score of 6.0 in unrinsed rabbit eyes and 3.3 in rinsed eyes. All eyes returned to normal within 14 days.