Reaction mass of octadecyl heptanoate and octadecyl octanoate

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:

other: Basic data given. There were omly few details on materials and methods reported in the study, the purity of the test substance was not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Oct 2012

Deviations:

yes

Remarks:

few details on materials and methods, analytical purity not reported

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

octadecyl heptanoate; octadecyl octanoate

EC Number:

915-334-0

Molecular formula:

C25H50O2 C26H52O2

IUPAC Name:

octadecyl heptanoate; octadecyl octanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: white, waxy substance
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman Animals Ltd.
- Weight at study initiation: 2.5 - 3.5 kg (males and females)
- Diet: standard rabbit diet, ad libitum
- Water: not specified, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

SCORING SYSTEM: FDA scoring system, identical to Draize scoring system, except a score of 0.5 is possible

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 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:

out of all 6 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 and #5

Time point:

other: mean over 24, 48 and 72 h

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #3, #4 and #6

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

4/6 rabbits had slight chemosis (score 1) and 2/6 had moderate chemosis (score 2) at the 1-hour reading time point. Slight chemosis persisted in 6/6 animals until the 72-hour reading time point, then cleared completely by 7 days after application. Slight to moderate conjunctivae was observed in 6/6 rabbits from the 1-hour reading time point. The conjunctivae persisted in all animals until the 72-hour reading time point, although the severity was reduced to score 1 in all animals. 7 days after instillation, 2/6 rabbits had slight conjunctivae, while the other 4/6 had no remaining eye effects. No effects were seen on the cornea and iris.

Any other information on results incl. tables

Table 1. Individual eye irritation scores

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	2	1	0	0
	24 h	2	1	0	0
	48 h	1	0.5*	0	0
	72 h 7 d	1 0.5*	0.5* 0	0 0	0 0
	Average*	1.33	1.0	0.0	0.0
2	1 h	2	1	0	0
	24 h	2	1	0	0
	48 h	2	1	0	0
	72 h 7 d	1 0	1 0	0 0	0 0
	Average*	1.67	1.0	0.0	0.0
3	1 h	1	2	0	0
	24 h	1	1	0	0
	48 h	0.5*	0.5*	0	0
	72 h 7 d	0.5* 0	0.5* 0	0 0	0 0
	Average*	1.0	1.0	0.0	0.0
4	1 h	1	1	0	0
	24 h	1	1	0	0
	48 h	1	1	0	0
	72 h 7 d	0.5* 0	0.5* 0	0 0	0 0
	Average*	1.0	1.0	0.0	0.0
5	1 h	2	1	0	0
	24 h	2	1	0	0
	48 h	1	0.5*	0	0
	72 h 7 d	1 0.5*	0.5* 0	0 0	0 0
	Average*	1.33	1.0	0.0	0.0
6	1 h	1	2	0	0
	24 h	1	1	0	0
	48 h	0.5*	1	0	0
	72 h 7 d	0.5* 0	0.5* 0	0 0	0 0
	Average*	1.0	1.0	0.0	0.0

*(24h+48h+72h)/3. The 0.5 scores were rounded up to 1 in order to follow the standard Draize scoring system.

 

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