Phenol, 2-methoxy-, reaction products with 2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane, hydrogenated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

(no data on starting date) 30-AUG 1976 (date of report)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted before GLP principles (1976). However, study performed according to basic scientific principles acceptable for assessment although some information is missing on test conditions and on test substance composition.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: performed according to standard method

Deviations:

not applicable

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Santal synthétique
- Analytical purity: not specified
See confidential details on test material for more information

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data available
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing: no data available
- Diet (e.g. ad libitum): no data available
- Water (e.g. ad libitum): no data available
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): no data available

IN-LIFE DATES: From: To: no data available

Test system

Vehicle:

other: vaseline oil

Amount / concentration applied:

TEST MATERIAL
- Concentration: 100% (as such), 10% and 30% (diluted product in vaseline oil)

VEHICLE
Vaseline oil. No other information available.

Duration of treatment / exposure:

no data available

Observation period (in vivo):

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

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

SCORING SYSTEM:
Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
- no swelling . 0
- any swelling above normal (includes nictitating membranes) ....................................................................................1
- obvious swelling with partial eversion of lids .............................................................................................................2
- swelling with lids about half-closed ............................................................................................................................3
- swelling with lids more than half-closed .....................................................................................................................4
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
- blood vessels normal ...................................................................................................................................................0
- a number of blood vessels definitely hyperemic (injected) .........................................................................................1
- diffuse, crimson colour, individual vessels not easily discernible ...............................................................................2
- diffuse, beefy red ........................................................................................................................................................3
Discharge
- absence of discharge ..................................................................................................................................................0
- slight discharge (does not include small amounts normally found in inner canthus) ...................................................1
- discharge with moistening of lids and hairs adjacent to lids ................................................................................ .......2
- discharge with moistening of lids and hairs on wide area around the eye .......................................................... ......3

Iris lesions
- normal ............................................................................................................................................................................0
- markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia, or injection,
any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) ..............................1
- no reaction to light, haemorrhage, gross destruction (any or all of these)....................................................................2

Corneal lesions
Degree of opacity (area most dense taken for reading)
- no ulceration or opacity ................................................................................................................................................0
- scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible ...........1
- easily discernible translucent area, details of iris slightly obscured ............................................................................2
- nacreous areas, no details of iris visible, size of pupil barely discernible ...................................................................3
- opaque cornea, iris not discernible through the opacity ...............................................................................................4
Area of opacity
- one quarter (or less) but not zero .................................................................................................................................1
- greater than one quarter but less than a half ................................................................................................................2
- greater than one half but less than three quarters ........................................................................................................3
- greater than three quarters up to whole area ................................................................................................................4

TOOL USED TO ASSESS SCORE: no data available

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: concentration 100%

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.38

Max. score:

2

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: concentration 100%

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

3

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: concentration 100%

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.05

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: concentration 100%

Irritant / corrosive response data:

Based on this score, the substance is sightly irritating for eyes in rabbit.
No details are given for the concentration of 10%, since no signs of irritation were noted.
For the concentration 30%, see details in table n°2. For the concentration 30%, the substance is very slightly irritating for eyes in rabbit. Irritant effects (scores 1) were observed at 24 hours and fully reversible within: 48 hours.

Other effects:

none

Any other information on results incl. tables

Table n°1: Local ocular tolerance in rabbits - 100% concentration (product as such)

Observations after :	Rabbits N°	Conjunctivae			Iris	Corneal opacity
		Discharge	Chemosis	Redness		Intensity	Area
1 hour	1 2 3 4 5 6	0 0 0 0 0 0	0 0 0 0 0 0	1 1 1 1 1 1	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0
1 day	1 2 3 4 5 6	0 1 0 2 0 0	0 0 0 0 1 0	1 1 1 1 1 1	1 0 1 1 1 1	0 0 0 1 1 1	0 0 0 4 2 2
2 days	1 2 3 4 5 6	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 1 0	0 0 0 0 1 0	0 0 0 0 1 0	0 0 0 0 4 0
3 days	1 2 3 4 5 6	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 1 0	0 0 0 0 1 0	0 0 0 0 0 0	0 0 0 0 0 0
4 and 7 days	1 2 3 4 5 6	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0

Table n°2: Local ocular tolerance in rabbits -30% concentration (in vaseline oil)

Observations after :	Rabbits N°	Conjunctivae			Iris	Corneal opacity
		Discharge	Chemosis	Redness		Intensity	Area
1 hour	1 2 3 4 5 6	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0
1 day	1 2 3 4 5 6	0 0 1 0 1 0	0 0 0 0 0 0	1 1 1 1 1 1	1 1 1 1 1 1	0 0 0 0 0 0	0 0 0 0 0 0
2, 3, 4 and 7 days	1 2 3 4 5 6	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the UN GHS and CLP criteria, the substance is not classified for the eye irritation.

Executive summary:

Rhodiantal IBCH (100% (as such), 30% and 10% (diluted product in vaseline oil) has been instilled in eye rabbits. Period of observation: 7 days. No more information is available.

Results: For the concentration 100%, mean scores (24, 48 and 72h) were 0.05 for chemosis, 0.44 for conjunctival redness, 0.38 for iritis and 0.22 for corneal opacity. Based on this score the substance is slightly irritating for eyes in rabbit. According to the GHS and CLP criteria, the substance is not classified for the eye irritation. For the concentration 30%, the substance is very slightly irritating for eyes in rabbit. Irritant effects (scores 1) were observed at 24 hours and fully reversible within: 48 hours.

For the concentration 10%, no signs of irritation were noted.