Stearic acid, monoester with glycerol

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:

key study

Study period:

11 Jan - 11 Mar 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According 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:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: M.A.F.F. No. 4200 (1985)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 mono- and di-

EC Number:

286-490-9

EC Name:

Glycerides, C16-18 mono- and di-

Cas Number:

85251-77-0

Molecular formula:

C19H38O4, C21H42O4, C35H68O5, C39H76O5

IUPAC Name:

Glycerides, C16-18 mono- and di-

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01
- Other: pH = 5.8;
- Other: volumetric mass = 0.54 g/mL

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.38-2.66 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet: about 150 g/animal/day pelleted complete rabbit diet 112 C-10 (Usine d'Alimentation Rationnelle, Epinay-sur-Orge, France)
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 Jan 1999 To: 28 Jan 1999

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL (54 mg)
The test substance was crushed to a fine powder for eye treatment.

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0.11

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Slight to moderate effects on the conjunctivae (redness and chemosis) and slight effects on the iris (congestion) were observed in all animals 1 h after test substance instillation. In a single animal, effects on the iris persisted up to 48 h and reversed thereafter. No effects on cornea were observed in any animal tested.

Other effects:

No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1. Results of eye irritation study

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	chemosis
1	1	1	1	1 l	0 h
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
2	1	1	0	1 c	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
3	1	2	1	1 c	0
	24	0	0	1 l	0
	48	0	0	1 l	0
	72	0	0	0	0
	average	0	0	0.67	0
4	1	2	1	1 l	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
5	1	2	2	1 l	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
6	1	1	1	1 l	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	1.50	1.00	1	0
	24	0.00	0.00	0	0
	48	0	0	0	0
	72	0	0	0	0
	24+48+72	0	0	0.11	0

h = slight adherence of the test article to the corneal surface; c = circumcorneal injections + congestions of the iris; l = circumcorneal injections

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