Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.42

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids

Molecular formula:

Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.

IUPAC Name:

Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids

Test material form:

solid: flakes

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: H.Schriever, D-2740 Bremervörde
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 °C
- Humidity (%):-
- Air changes (per hr):-
- Photoperiod (hrs dark / hrs light):12/12 hours

Test system

Vehicle:

water

Remarks:

aqua dest.

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.: 100 mg neat after been pesteled in mortar
2. : 0.1 ml of a 50 % suspension in aqua dest.

Duration of treatment / exposure:

no washing

Observation period (in vivo):

24h, 48h, 72h, 7d

Number of animals or in vitro replicates:

2 x 6 rabbits

Details on study design:

The test item was placed into the conjunctival sac of one eye, while the second eye was used as a control.
Ocular reactions were assessed 24, 48 and 72 h as well as 7 days after treatment.

REMOVAL OF TEST SUBSTANCE
- no

SCORING

According to "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics published by the Food and Drug Officials of the United States, 1959".
I.) Cornea opacity Value
No opacity 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Complete corneal opacity, iris not discernible 4

I.) Cornea area Value
One quarter (or less) but not zero 1
Greater than one quarter, but less than one half 2
Greater than one half, but less than three quarters 3
Greater than three quarters, up to whole area 4

II.) Iris Value
Normal 0
Folds above normal, congestion, swelling, moderate circumcorneal injection
(any of these or any combination of them), iris still reacting to light 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

III.) Conjunctivae redness Value
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

III.) Conjunctivae chemosis Value
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids half closed to complete closed 4

III.) Conjunctivae discharge Value
No discharge 0
Any amount different from normal ( does not include small amounts
observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to the lids 2
Discharge with moistening of the lids and hairs and affecting a considerable
area around the eye 3


The Irritation Index was calculated from the numerical scores for cornea, iris and conjunctivae according to the following scheme:

I.) Cornea: opacity x area x 5 maximum 80
II.) Iris: iris x 5 maximum 10
III.) Conjunctivae: (redness + chemosis + discharge) x 2 maximum 20
sum = maximum 110

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 days

Score:

4.3

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

other: result for the neat test item

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 days

Score:

2.1

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

other: result for the 50 % suspension in aqua dest.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In this study the test substance is not irritating to the eye. According to the criteria of OECD GHS, Regluation (EC) 1272/2008 and of DSD (Directive 67/548/EEC) no classification and labelling is required.

Executive summary:

In a primary eye irritation study similar to OECD Guideline 405 0.1g of Grilloten PSE 141 neat or 0.1 ml of a 50 % suspension in water was instilled into the conjunctival sac of one eye, each of six New Zealand White rabbits. The eyes were not washed. Animals were then observed for 7 days.

Instillation of the test substance resulted in slight to moderate irritation of the conjunctivae, which consisted of redness and chemosis. The irritation completely resolved within 7 days.

In this study, Grilloten PSE 141 is not an eye irritant.