Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1996-03-18 to 1996-03-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Read-across from analogue substance. For justification of read-across and for further details please refer to the read-across report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Glyceryl Citrate/Lactate/Linoleate/Oleate

IUPAC Name:

Glyceryl Citrate/Lactate/Linoleate/Oleate

Constituent 2

Reference substance name:

91744-23-9

Cas Number:

91744-23-9

IUPAC Name:

91744-23-9

Details on test material:

- Substance type: product
- Physical state: liquid
- Stability under test conditions: > 1 year
- Storage condition of test material: at room temperatures in the dark
- Manufacture date: May 1995
- Lot/batch No.: 505024
- Expiration date of the lot/batch: not earlier than May 1996

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adult, no further details mentioned
- Weight at study initiation: 2.8 - 3.8 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 - Complete feed for rabbits, supplied by Ssniff, Spezialfutter GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after administration

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 24 hours after administration

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0

Other effects:

marked hyperaemias of some blood vessels in all animals one hour after application, after 24 hours no effects was noticed.

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	0/0/0
24 h	0/0/0	0/0/0	0/0/0	0/0/0
48 h	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
Average 24h, 48h, 72h	0	0	0	0
Area effected	-	-	-	-
Maximum average score (including area affected, max 110)	0	0	0	0
Reversibility*)	-	-	-	-
Average time (unit) for reversion	-	-	-	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this test the test item is not irritating to the eye.

Executive summary:

Eye irritation of the test substance (CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) was investigated in a study according to OECD 405 and GLP. 0.1 cm³ of the test substance were instilled in one eye each of the three New Zealand White rabbits. Total exposure was 24 h. Thereafter, the test substance was removed using warm physiological saline.

Observations were made after 1, 24, 48, and 72 h after administration. The untreated eye of each animal served as control.

Marked hyperaemias of some blood vessels could be observed in all animals 1 h after application, after 24 hours no effects was noticed. Mean scores for cornea, iris, conjunctivae redness and conjunctivae chemosis after 24, 48, and 72 h were 0 for each endpoint.

Based on the results of this test the substance is classified as not irritating.