4,4',4''-(ethan-1,1,1-triyl)triphenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with relevant guideline; selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

other: reference to body responsible for the test

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

Study was conducted according to guideline in effect at time of study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

EC Number:

405-800-7

EC Name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

Cas Number:

27955-94-8

Molecular formula:

C20H18O3

IUPAC Name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

Details on test material:

Nature of substance: Powder

Test animals / tissue source

Species:

other: Rabbit (New Zealand White)

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 13 weeks
- Weight at study initiation: 3.0-3.2 kg
- Housing: Metal cages with perforated floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Rabbits were acclimated; period of time not reported.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 90 mg (0.1 mL volume) per animal.

Duration of treatment / exposure:

A single exposure of test substance to the the eye.

Observation period (in vivo):

One hour and days 1, 2, 3, 4, and 7.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported.
- Time after start of exposure: Not reported.

SCORING SYSTEM:
Standardized grading system for cornea (0-4), iris (0-2), and conjunctiva (redness, 0-3; chemosis, 0-4) from the testing guidelines of the OECD.

TOOL USED TO ASSESS SCORE: Hand-held torch.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Time point:

other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)

Score:

1

Max. score:

1

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 10

Irritation parameter:

chemosis score

Time point:

other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)

Score:

1

Max. score:

1

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 14

Irritation parameter:

cornea opacity score

Time point:

other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)

Score:

0

Max. score:

0

Results 15

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 16

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 17

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 18

Irritation parameter:

iris score

Time point:

other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)

Score:

0

Max. score:

0

Irritant / corrosive response data:

Mild conjunctival inflammation observed one hour after instillation in all three animals. This was observed in one animal the following day. Reversibility of any observed effect: Grade 1 conjunctival redness and chemosis were observed in all three animals at 1 hour post-dose. Changes fully reversible within 2 days.

Any other information on results incl. tables

Table 1.0: Individual Animal Ocular Effects
Time	Cornea	Iritis	Conjunctiva
	Opacity		Redness	Chemosis
1 Hour	0	0	1	1
	0	0	1	1
	0	0	1	1
1 Day	0	0	1	0
	0	0	0	0
	0	0	0	0
2 Days	0	0	0	0
	0	0	0	0
	0	0	0	0
3 Days	0	0	0	0
	0	0	0	0
	0	0	0	0
4 Days	0	0	0	0
	0	0	0	0
	0	0	0	0
7 Days	0	0	0	0
	0	0	0	0
	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: transient, mild conjunctival irritation only

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). Exposure of the test substance to the rabbit eye produced mild conjunctival irritation only. This was fully reversible after 48 hours observation.

Executive summary:

The test substance was evaluated for acute eye irritation in rabbits. 90 mg test substance was administered to 1 eye of each test organism. Washing of eyes was not reported. The untreated eye served as a control. The treated eyes were evaluated and scored according OECD guideline numerical scale at approximately 1, 24, 48, 72, and 96 hours, and 7 days. No corneal damage or iridial inflammation was observed throughout the observation period. Mild conjunctival inflammation was observed one hour after instillation in all 3 test organisms; 1 after 24 hours. All irritation had reversed by 48 hours.