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:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

May 12. 1981

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate

EC Number:

274-011-6

EC Name:

Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate

Cas Number:

69452-87-5

Molecular formula:

C30H57O7PS3

Test material form:

liquid

Details on test material:

Generic name: TGE - Phosphite

Specific details on test material used for the study:

TEST MATERIAL NAME (as stated in study report): TK 12184 / 1 (Generic name: TGE - Phosphite)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 004-009
- Expiration date of the lot/batch: November, 1984
- Purity: commercial grade

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG. CB-4414, Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 1750-1890 9
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAPAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3° C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 animals

Details on study design:

Scoring system per test guideline

Results and discussion

In vivo

Results

Irritation parameter:

other: results

Remarks on result:

other: see narrative description below and attached table of results.

Irritant / corrosive response data:

No cornea or iris changes were observed.
Conjunctival redness: Grade 2 in all animals at 1 hr, and in one animal at 24 hr. Grade 1 in two animals at 24 hours and one animal at 48 hrs.
Conjunctival oedema: Grade 1 in all animals at 1 hr, and in one animal at 24 hr.
All eyes were normal at 72 hrs.

Other effects:

The animals showed a normal body weight development.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified by CLP Criteria

Conclusions:

In a guideline (OECD 405) in vivo eye irritation study, TGE Phosphite was mildlly irritating to the rabbit eye. Transient conjunctival redness and chemosis was observed, which did not reach levels for classification as an eye irritant according to CLP criteria. All eyes returned to normal within 72 hr.