2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

Cas Number:

125673-86-1

Molecular formula:

C15H26O

IUPAC Name:

rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

Constituent 2

Reference substance name:

rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

Molecular formula:

C15H26O

IUPAC Name:

rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

impurity 1

Reference substance name:

4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one

EC Number:

250-657-4

EC Name:

4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one

Cas Number:

31499-72-6

Molecular formula:

C13H22O

IUPAC Name:

4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one

Test material form:

liquid

Specific details on test material used for the study:

Identification: Boisiris
Description: colourless to pale yellow liquid
Batch Number: 149135
Stability of test article: stable; expiration date: June, 1989
Safety precautions: Gloves, goggles and face lask were sufficient to assure personnel health and safety

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Rationale: Recognized by the international guidelines as the recommended test system
Source: Kleinteirfarm madoerin AG, CH 4414 Fuellinsdorf / Switzerland
Number of animals per test: 2 males, 1 female
Age at start of treatment: males (15 weeks), female (16 weeks)
Body weight at start of treatment: males (2.5 - 2.8 kg) and females (2.7 kg)
Identification: By unique cage number and corresponding ear tags
Acclimatization: Four days inder laboratory conditions after veterinary examination

Conditions: Standard Laboratory Conditions. Air-conditions with 10-15 air changes per hour and hourly monitored environmental with temperature 20+/-3 degrees centigrade, relative humidity 40-70 %, 12 hours artificial flourescent light/ 12 hours dark, music/light period.

Accommodation: Individually in stainless steel cages equipped with an automatic cleaning and drinking system

Diet: Pelleted standard Kliba 341, Batch 42/88 rabbit maintenance diet ad libitum.

Water: Community tap water from Itingen, ad libitum.

Test system

Vehicle:

other: Neantine

Amount / concentration applied:

The test article was applied undiluted (100%) and diluted to 30% in Neantine.
Amount: 0.1 ml

Observation period (in vivo):

The eyes of each animal were examined 1, 24, 48 and 72 hours and 7 days after administration.

Number of animals or in vitro replicates:

3 animals

Details on study design:

The test article was placed in the conjunctival sac of the left (undiluted respectively right (diluted) eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article.
The eyes of the animals were observed 24 hours prior to test article administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

1.33

Max. score:

13

Remarks on result:

other: 100% concentration

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 71 hours

Score:

0.75

Max. score:

13

Remarks on result:

other: 30% concentration

Irritant / corrosive response data:

Boisris showed primary irritation scores of: 1.33 (100%) and 0.75 (30%), when applied to the rabbit eye mucosa.

Other effects:

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Colouration: In the area of application no staining of the cornea and conjunctivae by pigment or colouring of the test article was observed.

Opacity: Opacity was observed in all animals treated with the undiluted test article 1 hour (3), 24 hours (1) and 48 hours (1) after the test article application.

Body weights: The body weight gain of all rabbits was similar

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this experiment, Boisiris was found to cause primary irritaiton scores of:

Undiluted - 1.33 (100%)
Diluted - 0.75 (30%), when applied to the rabbit eye mucosa

No staining of the cornea and conjunctivae of the trated eyes by pigment of colouring of the test article was observed.

Opacity was observed in the animals treated with undiluted test article 1 hour (3), 24 hours (1) and 48 hours (1) after the test article application.

Executive summary:

Boisiris is not classified for eye irritation.