Amines, N-tallow alkyltrimethylenedi-, propoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-10-20 to 1980-10-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: test procedure in accordance with national standard methods with acceptable restrictions

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: Méthode officielle d'analyse des cosmétiques et des produits de beauté (Journal Officel de la République Française du 5 Avril 1971).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-({3-[(2-hydroxypropyl)[(9E)-octadec-9-en-1-yl]amino]propyl}amino)propan-2-ol; 1-({3-[(2-hydroxypropyl)amino]propyl}(octadecyl)amino)propan-2-ol; 1-({3-[hexadecyl(2-hydroxypropyl)amino]propyl}amino)propan-2-ol

EC Number:

614-637-2

Cas Number:

68603-75-8

Molecular formula:

R-N(CH2CHOHCH3)xCH2CH2CH2N(CH2CHOHCH3)y with x+y=3 and where R = alkyl

IUPAC Name:

1-({3-[(2-hydroxypropyl)[(9E)-octadec-9-en-1-yl]amino]propyl}amino)propan-2-ol; 1-({3-[(2-hydroxypropyl)amino]propyl}(octadecyl)amino)propan-2-ol; 1-({3-[hexadecyl(2-hydroxypropyl)amino]propyl}amino)propan-2-ol

Details on test material:

- Name of test material (as cited in study report): DINORAM SL
- Physical state: dark brown liquid
- Lot/batch No.: 2852
No other data available

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Centre d'elevage Charles River France, 76410 Saint Aubin les Elbeuf
- Age at study initiation: not reported
- Weight at study initiation: Male : 2-2.5 kg
- Housing: The rabbits were individuall y housed in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 60 ± 20 %
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left untreated eye in each animal

Amount / concentration applied:

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

Duration of treatment / exposure:

one instillation in conjunctival sac of right eye on day 0

Observation period (in vivo):

2 days (on day 3 euthanasia due to the extremely severe ocular reactions)

Number of animals or in vitro replicates:

6 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: cf free text of materials and methods. Grading scale used is equivalent to the one used in OECD 405.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

: 6 animals

Time point:

other: 24 and 48 hours

Score:

4

Max. score:

4

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

: 6 animals

Time point:

other: 24 and 48 hours

Score:

3

Max. score:

3

Irritant / corrosive response data:

No deaths occured during the study.
- 24h after instillation, a grade 4 chemosis was observed in all animals. Such a chemosis (eyes closed because of swollen lids) prevented from examinating iris and cornea. A grade 3 conjunctival redness and a grade 3 discharge were also noted in all animals. Furthermore, withish secretions were noted around lids.
- 48 h after instillation, no changes from the previous description were noted.
Since eyes of all rabbits were destroyed on day 3, it was decided to stop the study and kill them for humane reasons.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other:

Conclusions:

Under the experimental conditions of this study, the substance must be considered as corrosive for eyes and warrants a classification in category 1 , eye damage according to CLP regulation (Reg 1272/2008/EC) and a classification severely irritating for eyes Xi, R41 according to the directive 67/ 548/ EEC.

Executive summary:

The potential of the test substance to induce eye irritation was assessed in 6 rabbits according to a method similar to OECD 405 guideline in compliance with Good laboratory practices.

A single dose of 0.1ml of the test item was instilled into one eye, the other eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed 24 and 48 hours after the administration.

24hours after instillation, a grade 4 chemosis was observed in all animals. Such a chemosis (eyes closed because of swollen lids) prevented from examinating iris and cornea. A grade 3 conjunctival redness and a grade 3 discharge were also noted in all animals. Furthermore, withish secretions were noted around lids. 48 hours after instillation, no changes from the previous description were noted.

Since eyes of all rabbits were destroyed on day 3, it was decided to stop the study and kill them for humane reasons.

Under these experimental conditions, the test substance was considered corrosive when administered by ocular route to rabbits.