Amines, N-C12-18-alkyltrimethylenedi-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed pre-GLP and not according to standard protocol but comparable with OECD 405. Under current regulations an eye irritaion study would no be performed due to the observed corrosive effects on skin.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: according to a modification of the procedure described in 16 CFR.1500.42.

Principles of method if other than guideline:

Under current regulations an eye irritaion study would no be performed due to the extremely irritating effects on skin.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-C12-18-alkyltrimethylenedi-

EC Number:

268-957-9

EC Name:

Amines, N-C12-18-alkyltrimethylenedi-

Cas Number:

68155-37-3

Molecular formula:

R-NH-(CH2)3-NH2

IUPAC Name:

N-C12-18-alkyl-propane-1,3-diamine

Details on test material:

Duomeen C (N-coco-1 , 3 diaminopropane) no further data provided

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: from H.A.R.E.- Rabbits for Research, Hewi tt, N. J. (a USDA approved supplier)
- Age at study initiation: no data
- Weight at study initiation: 2-4 kg
- Housing: individually housed in wiremesh bottom cages
- Diet (e.g. ad libitum): Agway Charles River Rabbit Ration, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
Animals were kept in an environmentally controlled room.
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

In total 9 animals were used. The eyes of 3 animals were washed out after 4 seconds. The eyes of the other 6 animals were not washed out at all.

Observation period (in vivo):

The eyes were examined with sodium fluorescein and an ultraviolet lamp at 24, 48 and 72 hours and at 7 days.

Number of animals or in vitro replicates:

In total 9 animals were used.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed

SCORING SYSTEM: The Draize Scale for Scoring Ocular Lesions

TOOL USED TO ASSESS SCORE: fluorescein and an ultraviolet lamp

Results and discussion

In vivo

Results

Irritation parameter:

other: Corrositivity

Basis:

other: All animals

Time point:

other: 24 hours

Reversibility:

not reversible

Remarks on result:

other: Eyes toptally destroyed (eye and surrounding tissue necrossed and abcessed)

Irritant / corrosive response data:

In every case the corrosivity of Duomeen C was so severe that the treated eyes were totally destroyed (eye and surrounding tissue necrossed and abscessed) so t h a t no accurate readings could be taken. In every case the conjunctiva of the eye appeared to be bleached.

Applicant's summary and conclusion

Interpretation of results:

highly corrosive

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Due to the corrosivity of the test article accurate readings were not possible. The eye and surrounding tissue were necrosed, abscessed and bleached.

Executive summary:

The irritant/corrosive properties of N-coco-1,3 diaminopropane to the eyes was evaluated in an OECD 404 guideline study in rabbit eyes.

A volume of 0.1 ml of the test article was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then held together for one second. The eyes of 6 animals were not washed out after instillation of the test article. The eyes of 3 animals were washed out, approximately 4 seconds after instillation of the test article, by flushing with distilled water for about 10 seconds or until all visible test article was removed.

Due to the corrosivity of the test article accurate readings were not possible. The eye and surrounding tissue were necrosed, abscessed and bleached. The test substance can therefore be considered to be highly corrosive to the eyes without and with washout 4-seconds after instillation.