Octahydro-4,7-methano-1H-indene-5-methanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Initiation: March 01, 1983 - Termination: March 15,1983.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study; no data on TS purity reported

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

12 May 1982

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octahydro-4,7-methano-1H-indene-5-methanol

EC Number:

260-789-4

EC Name:

Octahydro-4,7-methano-1H-indene-5-methanol

Cas Number:

57526-50-8

Molecular formula:

C11H18O

IUPAC Name:

{tricyclo[5.2.1.0²,⁶]decan-8-yl}methanol

Test material form:

liquid

Details on test material:

Hoechst 1983

Specific details on test material used for the study:

No information about purity. However, as it is stated in the section 13, the substance and its composition have remained essentially the same over the last decades.

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Weight at study initiation: 1.7 - 1.8 kg (3 animals)
- Housing: individual cages in fully air-conditioned rooms
- Diet: feed for breeding rabbits ERKA Z 6000, ad libitum
- Water: deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 hours per day
Test system

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: yes, the untreated right eye

Amount / concentration applied:

Concentration: 100 %
Amount applied: 0.1 ml

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

14 days with readings after 1, 24, 48, 72 hours and 7 and 14 days post application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline at 37°C
- Time after start of exposure: 24 h after application

SCORING SYSTEM: Draize (see guideline)

TOOL USED TO ASSESS SCORE: 0.01% fluorescein sodium solution and UV light (24 and 72 h post application)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.55

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

probability of weak irritation

Any other information on results incl. tables

RS-Freetext:
The individual effects of the rabbit eye were scored as follows: 

Rabbit 1/2/3; 1h - 24hrs - 48 hrs - 72hrs - 7d -
14d
_______________________________________________
-Cornea:
1/1/1 - 1/1/2 - 1/1/2 - 0/1/2 - 0/1/2 - 0/0/1
     
-Iris
 1/1/1 - 1/1/1 - 0/0/1 - 0/0/1 - 0/0/0 - 0/0/0   
    
-Conjunctivae 
Redness: 
1/3/3 - 3/2/2 - 1/1/2 - 0/2/2 - 0/1/0 - 0/0/1         
Chemosis: 
1/2/2 - 2/2/1 - 1/2/1 - 0/1/2 - 0/0/1 - 0/0/0
_______________________________________________


The means of the effects were as follows:


           24 hrs      48 hrs    72 hrs
________________________________________
cornea     1.33       1.33       1.0
iris       1.0        0.33       0.33
Conjunc.
redness    2.33       1.33       1.33
chemosis   1.67       1.33       1.0  
________________________________________

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

CL-Freetext:
The TS caused moderate eye irritation in all animals.

The effects were reversible and were absent in two animals at 14 days after treatment. Cornea opacity and conjunctivae redness grade 1 persisted in one animal until the end of the observation period, however, the effects were less severe than after the beginning of the observation period. As it can reasonably be assumed, that the effects would have been fully reversible, if the observation period would have been extended to 21 days, it is concluded that the substance is irritating to the eyes (GHS Cat. 2A).

Executive summary:

Eye irritating effects have been investigated in rabbits according to OECD TG 405. At the end of the treatment period cornea opacity, as well as effects on the iris, and conjunctivae were observed (mean values after 24 -48 -72 hours for all three animals: 1.22, 0.55, 1.66 and 1.33, for cornea, iris, redness and chemosis, respectively). The effects were reversible and were absent in two animals at 14 days  after treatment. Cornea opacity  and conjunctivae redness grade 1 persisted in one animal  until the end of the 14 day observation period, however, the effects were less severe than after the beginning of the observation period.