Isononanoic acid, C16-18 (even numbered)-alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. No details on study protocol given as OECD was only cited as the guideline used, the analytical purity of the test substance is not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no details on study protocol

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate

EC Number:

261-665-2

EC Name:

3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate

Cas Number:

59219-71-5

Molecular formula:

C18H36O2

IUPAC Name:

3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate

Details on test material:

- Name of test material (as cited in study report): isononyl isonoanoate
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

3/3 rabbits had some or obvious chemosis and severe redness (conjunctivae, score 3 of 3) at the 1-hour reading time point (see Table 1). 24 hours after instillation of the test substance, 1/3 rabbits still exhibited some chemosis, which had cleared completely within 48 hours. The severity of the redness was slightly reduced in 2/3 rabbits and remained unchanged in 1/3 rabbits at the 24-hour reading time point. The chemosis was completely reversible within 72 hours. No effects on the cornea or iris were noted at any time point.

Any other information on results incl. tables

Table 1: individual irritation scores

 

Rabbit #	Time	conjunctivae		iris	cornea
		redness	chemosis
1	1 h	3	1	0	0
	24 h	3	0	0	0
	48 h	2	0	0	0
	72 h	0	0	0	0
	Average*	1.67	0.0	0.0	0.0
2	1 h	3	1	0	0
	24 h	2	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Average*	0.67	0.0	0.0	0.0
3	1 h	3	2	0	0
	24 h	2	1	0	0
	48 h	1	0	0	0
	72 h	0	0	0	0
	Average*	1.00	0.33	0.0	0.0

* mean of 24 + 48 + 72 h

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified