Fatty acids, C16-18, Me esters

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:

31 Mar - 10 Apr 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions; no data on analytical purity of the test substance were given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

analytical purity of test substance not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl palmitate

EC Number:

203-966-3

EC Name:

Methyl palmitate

Cas Number:

112-39-0

Molecular formula:

C17H34O2

IUPAC Name:

methyl palmitate

Details on test material:

- Substance type: Palmitic acid methyl ester
- Physical state: at room temperature, white solid; from 26°C, colourless liquid
- Purity: not specified
- Expiration date of the lot/batch: July 1992
- 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 GmbH, Biberach, Germany
- Age at study initiation: approx. 15 months
- Weight at study initiation: approx. 2800 g
- Housing: individually
- Diet: Ssniff rabbit diet K4, ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 hours
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE:
- Washing (if done): yes, rinsing with tap water
- Time after start of exposure: 24h

SCORING SYSTEM: according to the council directive 84/449/EEC (Draize scoring system)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no effect in any animal

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no effect in any animal

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: slight redness graded 1 was only seen at reading time point 24 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: slight redness graded 1 was seen at each of reading time points 1, 24 and 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: slight redness graded 1 was seen at reading time points 1 and 24 hour

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no effect in any animal

Irritant / corrosive response data:

One hour after exposure conjunctival redness graded 1 was seen in 2/3 animals; both animals also showed lacrimation graded 1. The third animals only had lacrimation of grade 2 at this reading time point. At reading time point 24 hour, all 3 animals showed slight erythema of grade 1 whereas lacrimation was no more seen. After 48 hours, erythema (grade 1) only remained in one animal, and after 72 hours, all 3 animals had fully recovered.

Any other information on results incl. tables

Evaluation of the eye lesions at reading time points 24, 48 and 72 hours

Animal	Hours after application
	24					48					72
	A	B	C	D	L	A	B	C	D	L	A	B	C	D	L
1241	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
1250	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0
1267	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0

A = Corneal Reaction

B = Effects on the iris

C = Erythem

D = Chemosis

L = Lacrimation

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