Methyl ricinoleate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 March 1999 -4 APril 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Methyl ricinoleate

EC Number:

205-472-3

EC Name:

Methyl ricinoleate

Cas Number:

141-24-2

Molecular formula:

C19H36O3

IUPAC Name:

methyl ricinoleate

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Animais
Sex, species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study. Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animais: three animais were used, as recommended by the international guidelines. Identification: the animais were identified individually with a metal ear tag.
Weight: on the day of treatment, the animais had a mean body weight ± standard deviation of 2.5 ± 0.2 kg.
Acclimatization: at least 5 days before the beginning of the study.

Environmental conditions
The conditions in the animal room were set as follows:
.temperature: 18 ± 3°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. ln addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animais were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle.

Food and water
During the study, the animais had free access to 112 C pelleted diet (UAR, 91360 Villemoisson­ sur-Orge, France).
Each batch of food was analysed by the supplier for composition and contaminant levels. The diet formula is presented in appendix 2.

Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by extemal laboratories.
The results of these analyses are archived at CIT.

No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

A single dose of 0.1 ml of the test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.

Observation period (in vivo):

The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance.

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

The study design was established according to available information on the test substance and the above guidelines.

As possible irritant effects were anticipated, the test substance was administered to a single male New Zealand White rabbit, in the first instance.
Since the test substance was not irritant for this first animal, it was administered to two other male New Zealand White rabbits.

A single dose of 0.1 ml of the test undiluted substance was instilled into the left conjunctival sac. The right eye was not treated and served as control.
The eyes were not rinsed after administration of the test substance.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration.

The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and comeal opacity were calculated for each animal

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: mean 3 r

Remarks:

rabbits

Time point:

other: 24-48-72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

chemosis score

Basis:

other: mean 3 rabbits

Time point:

24/48/72 h

Score:

0 - 0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: mean 3 rabbits

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

iris score

Basis:

other: mean 3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

0

Any other information on results incl. tables

lndividual ocular examinations and mean values of the scoresrecorded at each reading (24,48and72hours) for each animal

 

Rabbit    Region                  Description                                  Scores                                Mean      Interpretationnumber                ofeye                    ofocular                                                                             irritation                 (+)

reactions          lh            24h          48h          72h        score(1)              (-)

Dl             02            03          04

716	Conjunctivae	Chemosis	0	0	0	0	0.0	(-)
		Redness	0	0	0	0	0.0	(-)
		Discharge	E	0	0	0	0.0
	Iris		0	0	0	0	0.0	(-)
	Comealopacity	Intensity	0	0	0	0	0.0	(-)
		Arca	0	0	0	0	0.0
	OtherFluorescein		* I	*u	* I	* I
717	Conjunctivae	Chemosis	2	0	0	0	0.0	(-)
		Redness	2	0	0	0	0.0	(-)
		Discharge	E	0	0	0	0.0
	Iris		0	0	0	0	0.0	(-)
	Comealopacity	Intensity	0	0	0	0	0.0	(-)
		Arca	0	0	0	0	0.0
	OtherFluorescein		"' I	"' u	"' I	"' I
718	Conjunctivae	Chemosis	1	0	0	0	0.0	(-)
		Redness	1	0	0	0	0.0	(-)
		Discharge	E	0	0	0	0.0
	Iris		0	0	0	0	0.0	(-)
	Comealopacity	Intensity	0	0	0	0	0.0	(-)
		Arca	0	0	0	0	0.0
	OtherFluorescein		* I	"' u	"' I	"'

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Non irritating

Executive summary:

The study design was established according to available information on the test substance and the above guidelines.

A single dose of 0.1ml of the test undiluted substance was instilled into the left conjunctival sac.The right eye was not treated and served as control.

The eyes were not rinsed after administration of the test substance.

 

Ocular  reactions  were  observed  approximately  1hour,  24,  48  and  72 hours  after  the administration.

 

The mean values of the scores for chemosis, redness of the conjunctiva,iris lesions and comeal opacity were calculated for each animal.

 

 Results

 

Very slight reactions were observed in two animals on day 1 only; No other ocular reactions were observed during the study.

Mean scores alculated for eachanimal over 24,48 and 72hours were 0.0,0.0 and 0.0 for chemosis, 0, 0, 0, 0 and 0 for redness and 0 for iris lesions and 0 for corneal opacity.

Conclusion

Under our experimental conditions, the test substance RICINOLEATE DE METHYLE (batch No.9802001) is non-irritant when administered by ocular route to rabbits.