Fatty acids, soya, conjugated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

26 Feb - 04 Mar 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study tested with the source substance CAS 57-10-3. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Palmitic acid

EC Number:

200-312-9

EC Name:

Palmitic acid

Cas Number:

57-10-3

Molecular formula:

C16H32O2

IUPAC Name:

palmitic acid

Details on test material:

- Name of test material (as cited in study report): Edenor C16 - 92/94 (FS 008), Palmitinsäure
- Physical state / appearance: white powder
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrussen Chbb

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HM / Fa. Thomae, Biberach, Germany
- Weight at study initiation: ca. 2640 g
- Housing: individually (Fa. Heinkel, Kuchen, Germany)
- Diet: ad libitum Altromin diet 2023, Altromin GmbH, Lage, Germany
- Water: ad libitumcommunity tap water; ad libitum
- Acclimation period: at least 7 days


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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated left eyes served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

3 days (since only minor scores were observed that fully returned to normal within 3 days the experiment was cancelled due to animal welfare reasons; therefore the reduced observation period does not represent a deviation to the OECD Guideline)
Reading time points: 1 h, 6 h, 24 h, 48 h, 72 h after administration

Number of animals or in vitro replicates:

4

Details on study design:

TOOL USED TO ASSESS SCORE: fluorescein
Ca. 24 hours prior to administration the eyes of the rabbits were checked with 0.1 mL 0.5% fluorescein sodium solution to detect eye lesions. If there are no stainings after rinse off, the cornea is considered to be intact. 24 hours after application of the test item and macroscopical determination of mucosal irritation the treatment with fluorescein sodium solution was repeated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

other: exudation

Basis:

mean

Remarks:

out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Any other information on results incl. tables

Tab.1: Conjunctival reactions after application of 0.1 g Edenor C16 - 92/94 (undiluted, permanent, 4 male rabbits)

Time point after application	Redness		Chemosis		Exudation
	Individual data	Average	Individual data	Average	Individual data	Average
60 min	1 / 1 / 1 / 1	1.00	0 / 1 / 1 /1	0.75	0 / 0 / 0 / 1	0.25
6 h	1 / 2/ 1 / 1	1.25	0 / 0 / 0 / 0	0	2 / 0 / 0 / 1	0.75
24 h	1 / 1 / 1 / 1	1.00	0 / 0 / 0 / 0	0	0 / 0 / 0 / 0	0
48 h	0 / 0 / 0 / 0	0	0 / 0 / 0 / 0	0	0 / 0 / 0 / 0	0
72 h	0 / 0 / 0 / 0	0	0 / 0 / 0 / 0	0	0 / 0 / 0 / 0	0

Animal No. (from left to right) 790, 796, 798, 799

Reactions on the cornea and iris were not observed. The conjunctival reactions were slight and disappeared totally within 48 hours. Palmitic acid is not irritating to eyes / mucosa under the test conditions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified