Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26-01-2015 to 09-03-2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to the guidelines under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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:

2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole

EC Number:

800-253-4

Cas Number:

1419212-73-9

IUPAC Name:

2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole

Constituent 2

Reference substance name:

Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products

IUPAC Name:

Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products

Constituent 3

Reference substance name:

Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction

IUPAC Name:

Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction

Test material form:

liquid: viscous

Details on test material:

Identification: Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products
Physical state / Appearance: brown extremely viscous liquid
Storage Conditions: room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Strain: New Zealand White (Hsdlf:NZW)
- Age at study initiation: 12 and 20 weeks
- Weight at study initiation: 2.6 and 3.1 kg
- Housing: individually
- Water: ad libitum
- Feed: 2930C Teklad Global Rabbit diet ad libitum
- Acclimation period: ≥ 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥ 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL: 0.1 mL

Observation period (in vivo):

Animal 1 21 days, Animal 2 14 days
Scoring at 1, 24, 46 and 72 h and 7, 14 and 21 days after instillation

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize with calculations of irritation score according to modified version of the system described by Kay J.H. and Calandra J.C. (1962))

TOOL USED TO ASSESS SCORE: light of ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Other effects:

Body weight gain within normal ranges
No othetr signs of toxicity or pain

Any other information on results incl. tables

Animal no	1							2
	1	24	48	72	7	14	21	1	24	48	72	7	14
cornea	1	1	1	1	1	1	0	0	0	0	0	0	0
iris	1	1	1	1	1	0	0	1	1	1	1	0	0
conjunctivae
redness	2	2	2	2	2	1	0	2	2	2	2	1	0
chemosis	3	3	3	3	1	0	0	2	2	2	2	1	0
discharge	3	3	3	3	2	1	0	3	2	1	1	0	0

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The substance is irritating to the eyes

Executive summary:

The substance was installed in the eye of 2 rabbits (subsequently treated). The results are indicative for the classification as irritating to the eyes (category 2).