Fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limited information on test substance, observation period only 72 hours

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: U.S. Federal Register, 1973, Vol. 38, No. 187, Section 1500:42

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

limited information on test substance, observation period only 72 h, no rationale for in vivo testing, no initial testing with one animal, no topical anesthetics

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)

EC Number:

263-423-1

EC Name:

2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)

Cas Number:

62125-22-8

IUPAC Name:

62125-22-8

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: in grid bottomed galvanised metal cages
- Diet: 90 - 95 g / day, Product Ref. 16934, Spillers Agriculture Limited
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Air changes: air conditioned room
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100 %

Duration of treatment / exposure:

72 h

Observation period (in vivo):

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

Number of animals or in vitro replicates:

6 females

Details on study design:

REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Reversibility not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

animal: #1 and #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #2, #4, #5, #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #2 and #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #4

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h and 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #5

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

other: reversiblity was not assessed

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

other: reversiblity was not assessed

Irritant / corrosive response data:

24 h after exposure, chemosis was observed in 4 of 6 animals, which disappeared the next day. All 6 animals showed redness of the conjunctivae, which dissapeared in 3 animals the next day. At 72 h observation, redness was still observed in 2 animals. Since the observation was stopped after 72 h, there is no information on the reversibility of these effects in the remaining 2 animals.
Adverse effects on the cornea and the iris were not observed in any of the animals.

Any other information on results incl. tables

Table 1: Evaluation of the eye reaction

Rabbit No. / sex	Scoring [h]	Cornea	Iris	Conjunctiva
				Redness	Chemosis
1 / f	24	0	0	2	0
	48	0	0	0	0
	72	0	0	0	0
	Mean (24, 48, 72 h)	0	0	0.67	0
2 / f	24	0	0	2	1
	48	0	0	0	0
	72	0	0	0	0
	Mean (24, 48, 72 h)	0	0	0.33	0.33
3 / f	24	0	0	2	0
	48	0	0	1	0
	72	0	0	1	0
	Mean (24, 48, 72 h)	0	0	1.33	0
4 / f	24	0	0	1	1
	48	0	0	1	0
	72	0	0	0	0
	Mean (24, 48, 72 h)	0	0	0.67	0.33
5 / f	24	0	0	1	1
	48	0	0	1	0
	72	0	0	1	0
	Mean (24, 48, 72 h)	0	0	1.0	0.33
6 / f	24	0	0	1	1
	48	0	0	0	0
	72	0	0	0	0
	Mean (24, 48, 72 h)	0	0	0.33	0.33
Group mean (24, 48, 72h)		0	0	0.78	0.22

 

 

Applicant's summary and conclusion

Interpretation of results:

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