Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Not known if conducted to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol, ethoxylated

EC Number:

500-110-3

EC Name:

Propylidynetrimethanol, ethoxylated

Cas Number:

50586-59-9

Molecular formula:

C3H5(CH2O(C2H4O)xH) sum of x; >1 - <6.5 mol EO

IUPAC Name:

Propylidynetrimethanol, ethoxylated

Specific details on test material used for the study:

- Name of test material (as cited in study report): Polyol TP30
Trimethylolpropane, ethoxylated, molar ratio 1 : 3
clear viscous liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Buckmasters, Henham, Hertfordshire, England
- Age at study initiation: 12 - 14 weeks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye remained untreated and served as a control

Amount / concentration applied:

Amount applied: 0.1 ml

Observation period (in vivo):

after 1 hour and 1, 2, 3, 4 and 7 days after instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
Not rinsed


SCORING SYSTEM: Draize Scoring System


TOOL USED TO ASSESS SCORE: Standard opthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1 - #3

Time point:

other: 1 hour, 1, 2, 3, 4 and 7 days

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1 - #3

Time point:

other: 1 hour and 1, 2, 3, 4 and 7 days

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, 72 hrs

Score:

> 0 - <= 1

Max. score:

3

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: mean score after 72 hours: 0.3

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #2 and #3

Time point:

other: 24, 48, 72 hrs

Score:

> 0 - <= 1

Max. score:

3

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: mean score after 72 hours: 0.3

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 hrs

Score:

> 0 - <= 1

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: mean score after 72 hours: 0.3

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #2 and #3

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No corneal damage or iridial inflammation was recorded in any of the animals. Mild conjunctival irritation was recorded in all three animals, this had resolved two or three days after instillation. Thus instillation of the test substance into the rabbit eye did not elicit a positive response in any of the three treated animals.

Executive summary:

The eye irritation potential of Polyol TP 30 (propylidynetrimethanol, ethoxylated) was investigated in a rabbit study (OECD 405). Instillation of 0.1 mL of the material into one eye of three rabbits did not result in any corneal damage or iridial inflammation. Mild conjunctival irritation was recorded in all three animals; this resolved within two or three days after instillation. The reactions seen in this study are not sufficient to result in classification according to the CLP Regulation.