D-Gluconic acid, δ-lactone, reaction products with propanolamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 30 to April 9, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Hens Egg Test on the Chorio-Allantoic Membrane (HET-CAM).

Version / remarks:

Journal officiel de la République Française of December 26, 1996 with some modifications described in the Standard Operation Procedure N°TAM-01-v2

Deviations:

no

GLP compliance:

no

Remarks:

The study was performed according to national and/or international guidelines applying a study plan and Standard Operating Procedures. Although the performing laboratory is not GLP certified, test procedures are generally following GLP guidance and rules.

Test material

Test material information

Constituent 1

Reference substance name:

D-Gluconamide, N-(3-hydroxypropyl)-

Cas Number:

190445-18-2

Molecular formula:

C9H19NO7

IUPAC Name:

D-Gluconamide, N-(3-hydroxypropyl)-

Constituent 2

Reference substance name:

gluconic acid, aminopropanol salt

Molecular formula:

C9 H21 N1 O8

IUPAC Name:

gluconic acid, aminopropanol salt

Test material form:

liquid

Remarks:

50% solution in water

Details on test material:

% solids in water: 48.0 - 52.0

Specific details on test material used for the study:

ID: Samson 18+
Appearance: liquid
Storage: room temperature

Test animals / tissue source

Species:

chicken

Details on test animals or tissues and environmental conditions:

Eggs reception and incubation
- Upon receipt, the cracked or broken eggs are discarded. Before incubation, the eggs are stored in egg boxes (blunt ends upwards). If the incubation didn’t take place in few hours after reception, eggs are stored at 8°C; and kept away from light for a maximum of 7 days, then for 24 h at 20°C before being placed in an incubator.
- Clean and fertile White Leghorn chicken eggs are placed in an incubator for eight days with a rotating tray at 37.8 ± 0.5ºC and 52 ± 2% relative humidity.

Test system

Vehicle:

water

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

S18+ at 100%; 10%; 5% in 300 µL.

Duration of treatment / exposure:

300 seconds

Duration of post- treatment incubation (in vitro):

Not applicable

Number of animals or in vitro replicates:

Test article groups: 4; Controles: 2

Details on study design:

This test is carried out on 9 days’ old, fertilized and embryonated chicken eggs. The eggshell and inner membrane are carefully removed taking care that the CAM is not injured.
- Each test substance (if included, benchmark and solvent/vehicle controls) is applied to 4 eggs. Positive and negative controls are applied to only two eggs.
- 300 μl of test product are then deposited on the membrane. A timer is started immediately after application.
- At 20 seconds, test substance is removed from the membrane by rinsing the CAM with approximately 2x2.5 ml of DPBS 1X.
- The CAM reactions are observed over a period of 300 seconds. The time of the appearance of HAEMORRHAGE, HYPERAEMIA and COAGULATION should be monitored and recorded, in seconds
- Pictures are taken at 0, 30, 120 and 300 seconds and recorded as t=0s, t=30s, t=120s and t=300s for the corresponding tested substance.
- For each egg, the numerical time-dependant scores for HAEMORRHAGE, HYPERAEMIA and COAGULATION are summed to give a single numerical value.
- The Irritation Score (IS) of the tested product is the arithmetic average, rounded to the decimal, of the scores obtained on four eggs (treated with a same test substance). Therefore, the maximal score is 21.
IS < 1 = Practically not irritant
1 ≤ IS < 5 = Slightly irritant
5 ≤ IS < 9 = Moderately irritant
IS ≥ 9 = Irritant

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

100%

Value:

2.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

Value = 0

Positive controls validity:

valid

Remarks:

Values: NaOH 1N = 19; NaOH 0.1N= 10

Remarks on result:

other: Slightly irritant

Results 2

Irritation parameter:

in vitro irritation score

Run / experiment:

10%

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to HET-CAM test, Samson S18+ at 100% is identified as Slightly irritant and Samson S18+ at 10% in H2O is identified as Practically not irritant.