Fatty acids, C8-10, Me esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-03-11 to 1988-03-31

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

: lack of details on test substance; lack of individual tabulated data on cornea and iris; reading at 72 in only 1 animal

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C8-10, Me esters

EC Number:

287-636-4

EC Name:

Fatty acids, C8-10, Me esters

Cas Number:

85566-26-3

Molecular formula:

C9-11H18-22O2

IUPAC Name:

Fatty acids, C8-10 (even numbered), Me esters

Details on test material:

- Substance type: Fatty acid methyl ester, C8-10
- Physical state: clear yellowish liquid
no further details

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrussen , Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Weight at study initiation: mean 2467.5 g
- Housing: individually
- Diet: ad libitum (Altromin Haltungsdiät 2023)
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM: according to 79/831/EWG, Annex, Part B

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 4 tested animals and mean of readings at

Time point:

other: 24 h and 48 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 4 tested animals and mean of readings at

Time point:

other: 24 h and 48 h

Score:

0

Max. score:

3

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 4 tested animals and mean of readings at

Time point:

other: 24 h and 48 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 4 tested animals and mean of readings at

Time point:

other: 24 h and 48 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No reactions were observed on the cornea and the iris.
The conjunctival reactions were slight to moderate and disappeared totally within 24 hours after application.

Any other information on results incl. tables

Evaluation of the eye lesions

 

 

Animal	Hours after application
	24			48			72
	A	B	C	A	B	C	A	B	C
718	0	0	0	0	0	1	0	0	0
917	0	0	0	0	0	0	-	-	-
918	0	0	0	0	0	0	-	-	-
920	0	0	0	0	0	0	-	-	-

A = Redness

B = Chemosis

C = Exsudation

- = Not evaluated

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU