N-[3-(dimethylamino)propyl]stearamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-09-13 to 2012-09-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

May 2008

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 April 2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]stearamide

EC Number:

231-609-1

EC Name:

N-[3-(dimethylamino)propyl]stearamide

Cas Number:

7651-02-7

Molecular formula:

C23H48N2O

IUPAC Name:

N-[3-(dimethylamino)propyl]octadecanamide

Test material form:

solid: pellets

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.88 kg
- Housing: individually
- Diet (e.g. ad libitum): pelleted rabbit diet, app. 100 g/day, hay + wooden sticks
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Air changes (per hr):app. 15/h
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated contralateral eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 53.6 mg (approximately 0.1 mL)

Duration of treatment / exposure:

eyes were not rindes after treatment

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: Draine (OECD Guideline 405)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: ca 27 h

Score:

2

Max. score:

4

Reversibility:

other: no further observation due to severity of effects

Remarks on result:

other: Animal sacrificed and eye scored following the 24 hours observation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: ca 27 h

Score:

0

Max. score:

2

Reversibility:

other: no further observation due to severity of effects

Remarks on result:

other: Animal sacrificed and eye scored following the 24 hours observation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: ca. 27 h

Score:

3

Max. score:

3

Reversibility:

other: no further observation due to severity of effects

Remarks on result:

other: Animal sacrificed and eye scored following the 24 hours observation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h

Score:

3

Max. score:

3

Reversibility:

other: no furtehr observation due to severity of effects

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 h

Score:

4

Max. score:

4

Reversibility:

other: no further observation due to severity of effects

Irritant / corrosive response data:

Instillation of 53.6 mg of the test substance into an eye of one rabbit resulted in severe effects on the eyes, necessitating intermediate sacrifice of the animal for ethical reasons approximately 27 hours after dosing. The eye lesions consisted of an injury of the cornea (opacity maximum grade 2), iridial irritation grade 1 and severe effects on the conjunctivae (grey/white coloration indicating necrosis, redness, chemosis and bloody discharge). Fluorescein examination could not be performed due to the bloody discharge. Scoring of the cornea, iris and eyelids was not possible in vivo 24 hours after instillation due swelling and exudation. Due to the severity of effects in this animal, no further animals were treated.

Other effects:

No remnants were noted one and 24 hours after instillation. White remnants of the test substance were found ex vivo in the conjunctival sac of the eye following sacrifice, 27 hours after instillation.
No symptoms of systemic toxicity were observed in the animal during the test period.

Any other information on results incl. tables

	1 h	24 h	Ex vivo (Animal sacrificed and eye scored following the 24 hours observation)
Cornea, opacity	0	n.a.	2
Iris	1	n.a.	0
Conjunctival redness	2	3	3
Chemosis	4	4	n.a.
Conjunctival discharge	2	3	n.a.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

In this study, Stearic acid 3-(dimethylaminopropyl)amide has irreversible effects on the eyes (Category 1).

Executive summary:

In a primary eye irritation study according to OECD guideline 405, adopted 24 April 2002 and EU method B.5, May 2008, 53.6 mg (approximately 0.1 mL) of Stearic acid 3-(dimethylaminopropyl)amide was instilled into the conjunctival sac of an eye of a male young adult New Zealand White rabbit. The eye was not rinsed after application. The animal was observed for 24 h.  Irritation was scored by the method of Draize.

Instillation of the test substance into the eye resulted in severe effects on the eyes, necessitating intermediate sacrifice of the animal for ethical reasons approximately 27 hours after dosing.

The eye lesions consisted of an injury of the cornea (opacity maximum grade 2), iridial irritation grade 1 and severe effects on the conjunctivae (grey/white coloration indicating necrosis, redness, chemosis and bloody discharge).

Fluorescein examination could not be performed due to the bloody discharge. Scoring of the cornea, iris and eyelids was not possible in vivo 24 hours after instillation due to swelling and exudation. Due to the severity of effects in this animal, no further animals were treated.

In this study, Stearic acid 3-(dimethylaminopropyl)amide has irreversible effects on the eyes (Category 1).