1-methyl-1,2-ethanediyl dioleate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 May - 24 May 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

GLP-Guideline study, tested with the source substance Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (CAS No. 84988-75-0). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol

EC Number:

284-864-6

EC Name:

Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol

Cas Number:

84988-75-0

Details on test material:

- Test Material: Fatty acids, C14-18 and C16-18 unsaturated, ester with propylene glycol
- Lot/batch No.: 0130 (from January 16, 1991)
- Expiration date of the lot/batch: 1991-07-16
- Stability under test conditions: stable for at least 1.5 years
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 4 months
- Weight at study initiation: 2370 g
- Housing: individually housed in cages (E. Becker & Co)
- Diet: Ssniff rabbit diet K4 Charge: 66029126 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was rinsed with tepid tap water.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Cornea/ Iris: No effects on cornea/iris were observed in any animal during the study period.
Conjunctivae: After 1 and 24 h 2/3 animals showed slight erythema being fully reversible within 48 h.
Chemosis: In 1/3 animals slight chemosis was observed after 1 h being fully reversible within 24 h. No further edema formation was observed during the study period in any animal.

Other effects:

No further local or system effects were reported.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

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	1	0	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.0	0.0	0.0
3	1	1	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.0	0.0	0.0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	0.67	0.33	0.00	0.00
	24	0.67	0.00	0.00	0.00
	48	0.00	0.00	0.00	0.00
	72	0.00	0.00	0.00	0.00
	24+48+72	0.22	0.00	0.00	0.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Cornea/ Iris: No effects on cornea/iris were observed in any animal during the study period.
Conjunctivae: After 1 and 24 h 2/3 animals showed slight erythema being fully reversible within 48 h.
Chemosis: In 1/3 animals slight chemosis was observed after 1 h being fully reversible within 24 h. No further edema formation was observed during the study period in any animal.
No further local or system effects were reported.
The test substance is determined to be not eye irritating.