13-Docosenamide, N-[3-(dimethylamino)propyl]-, (13Z)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 24 December 2008 to 5 February 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study without any restriction

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Erucamidopropyl dimethylamine

IUPAC Name:

Erucamidopropyl dimethylamine

Constituent 2

Reference substance name:

13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-

EC Number:

604-714-9

Cas Number:

149968-48-9

Molecular formula:

not applicable (a generic molecular formula cannot be provided for this UVCB substance)

IUPAC Name:

13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-

Test material form:

other: solid, light beige

Details on test material:

- Storage condition of test material: at room temperature, light protected

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V, The Netherlands
- Age at study initiation: 16 weeks
- Weight at study initiation: 2437g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood Blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Klibba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): communitu tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, music during the daytime period

IN-LIFE DATES: From: To: 24 to 31 December 2008

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g of the test item previsously grounded with a pestle and motar.
- Concentration (if solution): not applicable

VEHICLE
not applicable

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

2 days after the instillation

Number of animals or in vitro replicates:

One female.

Details on study design:

REMOVAL OF TEST SUBSTANCE
No rinsing just after instillation was performed. The eye of the treated female was rinsed before the 24-hour examination to allow an assessment of the scores (this was prevented by the test item remnants present in the eye). The eye was also rinsed after the 48-hour reading. The lavage was performed with approximately 20 mL physiological saline.

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

for the treated female

Time point:

other: overall 24, 48h

Score:

2.5

Max. score:

4

Reversibility:

other: not assessed

Remarks on result:

other: animal killed for humane reason after the 48-hour examination

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

for the treated female

Time point:

other: overall 24, 48h

Score:

2

Max. score:

2

Reversibility:

other: not assessed

Remarks on result:

other: animal killed for humane reason after the 48-hour examination

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

for the treated female

Time point:

other: overall 24, 48h

Score:

3

Max. score:

3

Reversibility:

other: not assessed

Remarks on result:

other: animal killed for humane reason after the 48-hour examination

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

for the treated female

Time point:

other: overall 24, 48h

Score:

4

Max. score:

4

Reversibility:

other: not assessed

Remarks on result:

other: animal killed for humane reason after the 48-hour examination

Irritant / corrosive response data:

A slight opacity of the cornea affecting the whole area was noted in the treated female at the 24-hour reading and progressed into moderate at the 48-hour evaluation. The light reflex was absent 24 to 48 hours after test item instillation. Moderate reddening and obvious swelling (chemosis) of the conjunctivae were noted 1 hour after treatment which progressed into marked reddening and marked swelling at the 24- and 48-hour reading. The sclerae of the animal were moderately reddened at the 1-hour observation and were not assessable 24 to 48 hours after treatment due to the swelling of the conjunctivae. Moderate ocular discharge was noted 1 to 48 hours after test item exposure. Blood was noted in the eye of the animal at the 48-hour evaluation.
See Table 7.3.2/1.

Other effects:

The treated female showed uneven head and severe signs of pain during the examination of the eye at the 48-hour reading and was therefore sacrificed immediately thereafter. The treated female showed a slight body weight loss (-0.6%) between treatment and last observation day.

Any other information on results incl. tables

Table 7.3.2/1:Irritant/corrosive response data for the treated animal at each observation time up to removal of the animal from the test for ethical reason.

Score at time point / Reversibility	Cornea	Area of corneal opacity	Iris	Conjunctivae	Chemosis	Sclera
	Max. score: 4	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4	Max. score: 3
1h	0	0	0	2	2	2
24 h	2	4	2	3	4	n.a.
48 h	3	4	2	3	4	n.a.

n.a. : not assessable due to swelling of the conjunctivae

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, considering the severity of the ocular observed effect in the treated female, Erucamidopropyl dimethylamine is classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC.

Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405 / EU Method B.5, and in compliance with the GLP, 0.1 g of undiluted Erucamidopropyl dimethylamine (purity > 99%) was placed into the left eye of one New Zealand white female Rabbit. After the instillation the substance was not rinsed. Animals were then observed for eye edema and erythema of the conjunctive, corneal opacity and iris lesion. 

Eye irritation was assessed and scored according to the Draize scale at 1, 24 and 48 hrs after the instillation of the substance. The treated female was killed for ethical reason after the 48-hour examination due to the severity of the ocular observed effects.

Indeed, a slight opacity of the cornea affecting the whole area was noted in the treated female at the 24-hour reading and progressed into moderate at the 48-hour evaluation. The light reflex was absent 24 to 48 hours after test item instillation. Moderate reddening and obvious swelling (chemosis) of the conjunctivae were noted 1 hour after treatment which progressed into marked reddening and marked swelling at the 24- and 48-hour reading. The sclerae of the animal were moderately reddened at the 1-hour observation and were not assessable 24 to 48 hours after treatment due to the swelling of the conjunctivae. Moderate ocular discharge was noted 1 to 48 hours after test item exposure. Blood was noted in the eye of the animal at the 48-hour evaluation.

 

Under the test conditions, Erucamidopropyl dimethylamine is classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.