Tributylethylammonium ethyl sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August - October 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tributylethylammonium ethyl sulphate

EC Number:

268-329-4

EC Name:

Tributylethylammonium ethyl sulphate

Cas Number:

68052-51-7

Molecular formula:

C14H32N . C2H5O4S (or C16H37NO4S)

IUPAC Name:

tributyl(ethyl)azanium ethyl sulfate

Details on test material:

- Name of test material (as cited in study report): TBEAES
- Substance type: organic
- Physical state: Paste
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Charles River Deutschland, Kisslegg, Germany.
- Age at study initiation: Animals used withihn the study were 12-14 weeks old.
- Weight at study initiation: Body weights were 2413 - 2605 grams.
- Housing: Individually housed in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany). Hay was available during the study period.
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
Set to maintain:
- Temperature (°C): 21±3
- Humidity (%): 30 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12

Deviations from these optimal condition were noted, but were considered not to have affected study integrity.

IN-LIFE DATES: From: 7 august 2000 to 13 september 2000

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each animal remained untreated and served as the reference control.

Amount / concentration applied:

average 47.4 ± 0.6 mg (a volume of approximately 0.1 mL)

Duration of treatment / exposure:

Single instillation on Day 1.

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance

Number of animals or in vitro replicates:

3 males

Details on study design:

TREATMENT
Each animal was treated by instillation of the test substance in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to installation).
- Necropsy: No histopathology was performed
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to OECD 405.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: animal #3 iris score 1 at 1 hour which was fully reversible within 24 hours

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Irritation
Instillation of test substance into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in one animal after 1 hour only. Irritation of the conjunctivae was seen as redness, chemosis and discharge which had completely resolved within 72 hours in one animal and within 7 days in the other two animals.

Corrosion
There was no evidence of ocular corrosion.

Other effects:

No staining of peri-ocular tissues by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an eye irritation study with rabbits, performed according to OECD/EC test guidelines, no corrosion was observed. Irritation of the conjunctivae was seen as redness, chemosis and discharge which had completely resolved within 72 hours (one animal) or within 7 days (two animals). No corneal opacity or corneal epithelial damage was observed. Based on these results TBEAES does not have to be classified and has no obligatory labelling requirements.

Executive summary:

Assessment of acute eye irritation/corrosion was performed with TBEAES in the rabbit according to OECD/EC guidelines and in accordance with GLP principles. Installation of single samples of TBEAES into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in one animal after 1 hour only. Irritation of the conjunctivae was seen as redness, chemosis and discharge which had completely resolved within 72 hours in one animal and within 7 days in the other two animals. There was no evidence for ocular corrosion. No corneal opacity or corneal epithelial damage was observed. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TBEAES does not have to be classified and has no obligatory labelling requirements for eye irritation.