Fatty acids, C16-18, esters with pentaerythritol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 21st, 1991 - May 24th, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: No data on vehicle given

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Fatty acid C16-18, ester with pentaerythrit
- Physical state: Solid, white
- Analytical purity: 99%
- Lot/batch No.: 51531022
- Stability under test conditions: 18 months
- Storage condition of test material: 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, Germany
- Age at study initiation: 4 months
- Weight at study initiation: approx.2090 g
- Housing: single holding in cage
- Diet (e.g. ad libitum): ad libitum (Ssniff rabbit diet K4
- Water (e.g. ad libitum):ad libitum



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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left, untreated eye served as control

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit): No Data

Duration of treatment / exposure:

single application, 24 h

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was thoroughly rinsed with warm water.
- Time after start of exposure: 24 h


SCORING SYSTEM: According to Council Directive 84/449/EEC

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all tested animals and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects

Remarks on result:

other: No reactions at any time point in any tested animal

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all tested animals and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

2

Reversibility:

other: No effects

Remarks on result:

other: No reactions at any time point in any tested animal

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all tested animals and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

3

Reversibility:

other: No effects

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all tested animals and readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects

Irritant / corrosive response data:

No effects were observed except a very mild and reversible exsudation reaction in one out of three animals 24 h after application.

Any other information on results incl. tables

Animal	Hours after application
	1					24					48					72
	A	B	C	D	E	A	B	C	D	E	A	B	C	D	E	A	B	C	D	E
1237	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
1238	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1240	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

A = Cornea Score

B = Iris Score

C = Erythema Score

D = Chemosis Score

E = Exsudation Score

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU