2-Propenoic acid, heptadecyl ester, branched

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

heptadecyl (branched) acrylate

EC Number:

810-816-6

Cas Number:

1473386-36-5

Molecular formula:

C20H38O2

IUPAC Name:

heptadecyl (branched) acrylate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS GmbH, Germany
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.46 kg - 2.53 kg
- Housing:single housing
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany (ad libitum)
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: alt least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: neagtive control: untreated left eye

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of the animal(s) was rinsed with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours

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

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

		Cornea		Iris	Conjunctiva
Readings	Animal No.	Opacity	Area of cornea involved		Redness	Chemosis	Discharge	Additional Findings
1 h	1	0	0	0	1	1	0	48
	2	0	0	0	1	1	0	48
	3	0	0	0	1	1	0	48
24 h	1	0	0	0	1	1	0	48, FL.neg.
	2	0	0	0	0	0	0	FL.neg.
	3	0	0	0	0	0	0	FL.neg.
48 h	1	0	0	0	1	0	0	FL.neg.
	2	0	0	0	0	0	0	FL.neg.
	3	0	0	0	0	0	0	FL.neg.
72 h	1	0	0	0	0	0	0	SD
	2	0	0	0	0	0	0	SD
	3	0	0	0	0	0	0	SD
Mean                 24h - 72 h	1	0.0	-	0.0	0.7	0.3	-
	2	0.0	-	0.0	0.0	0.0	-
	3	0.0	-	0.0	0.0	0.0	-
Mean	-	0.0	-	0.0	0.2	0.1	-

48: scleral vessels injected, circumscribed area, central ingrown

FL.: fluorescein

neg.: negative

SD: study discontinued because the animal was free of findings

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity and for iris lesions, 0.7, 0.0 and 0.0 for redness of the conjunctiva and 0.3, 0.0 and 0.0 for chemosis.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the described ocular reactions as well as the average score for irritation, Heptadecyl Acrylate (C17A) does not show an eye irritating potential under the test conditions chosen.