Methyl ricinoleate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Mar - 04 Apr 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

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:

TEST ANIMALS- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France- Weight at study initiation: 2.5 ± 0.2 kg- Housing: The animals 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.- Diet: 112 C pelleted diet (UAR, 91360 Villemoisson­ sur-Orge, France), ad libitum- Water: filtered drinking water (FG Millipore membrane (0.22 micron)), ad libitum- Acclimation period: at least 5 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 3- Humidity (%): 30 to 70- Air changes (per hr): approximately 12; filtered, non-recycled air- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL - Amount(s) applied: 0.1 mL

Observation period (in vivo):

Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE - Washing: The eyes were not rinsed after administration of the test substance.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritant / corrosive response data:

Slight conjunctivae redness and chemosis (score 1) were observed in 1/3 animals at the 1-h reading time point, which cleared within 24 h. Moderate conjunctivae and chemosis (score 2) were observed in 1/3 animals at the 1-h reading time point, which disappeared within 24 h. No effects on the iris and cornea were noted in any rabbit at any time point.

Any other information on results incl. tables

Table 1: Individual scores

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0,0	0,0	0,0	0,0
2	1	2	2	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0,0	0,0	0,0	0,0
3	1	1	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0,0	0,0	0,0	0,0

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

CLP: not classified