Ammonium carbonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004.08.02 - 2004.08.23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: In accordance with OECD, EC, OPPTS and MAFF Guidelines with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Testing Guideline of 12 Nousan No.8147

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammoniumcarbonat

IUPAC Name:

Ammoniumcarbonat

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Physical state: Solid, white powder
Test substance number: 04/0240-1
Batch number: 71774036W0

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST SPECIES
Strain: New Zealand White A1077 INRA (SPF)
Origin: Centre Lago S.A., 01540 Vonnas, France
Number: 3
Sex: Males/Females
Identification of animals: Ear tattoo
Age at study initiation: about 4 months
Weight at study initiation: 3.10-3.24kg

TEST CONDITIONS
Temperature: 20-24ºC
Relative humidity: 30-70%
Photoperiod: 12h light(6am-6pm)/12h dar(6pm-6am)
Housing: Stainless steel wire mesh cages with grating, floorarea: 3000 CM2, single housing.
Diet: Kliba-Labordiät (Kaninchen & Meerschweinchen- haltung "GLP"), Provimni Kliba SA, Kaiseraugst, Basel, Switzerland (about 130g/animal/day)
Water: Tap water ad libitum
Acclimation period: yes: 5 days prior to start of study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL bulk volume (about 66 mg of the comminuted test substance)

Duration of treatment / exposure:

1h

Observation period (in vivo):

Approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.

Number of animals or in vitro replicates:

3

Details on study design:

CONDUCT OF THE STUDY

Body weight determination: Just before application of the test substance and after the last reading.
Route of application: The test substance was applied in a single dose to the conjunctival sac of the right eyelid.
Application volume: 0.1 mL bulk volume (about 66 mg of the comminuted test substance)
Rinsing of the eye: About 1 hour after application of the solid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
Negative control: Untreated left eye
Readings: Approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
Illumination used tor reading: Daylight tubes "Lumilux" (L-58W/860 PLUS ECO 25x1, Osram, Germany)
Check tor dead or moribund animais: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.

SCORING SYSTEM
The evaluation of eye irritation is performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(Opacity)

Basis:

mean

Time point:

other: 24-72h

Score:

0.2

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(Redness)

Basis:

mean

Time point:

other: 24-72h

Score:

2

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72h

Score:

0.8

Any other information on results incl. tables

The ocular reactions were reversible in 2 animals within 7 days and in 1 animal within 14 days after application.

In addition discharge of blood, scleral vessels injected in a circumscribed area or circular and marginal vascularization of the cornea in a circumscribed area were noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the described ocular reactions as weil as the average score tor irritation, Ammroniumcarbonat does not show an eye irritation potential under the test conditions chosen.

Executive summary:

The aim of the study was to assess the eye irritation potential of the test substance tor product safety and regulatory purposes.

All available Information on toxicological and physico-chemical properties of the test substance including considerations concerning structure-activity-relationships did not indicate severe eye irritating properties. Therefore the eye irritation potential was tested in vivo in the rabbit.

The potential of Ammoniumcarbonat to cause damage to the conjunctiva, iris or corneawas assessed by a single ocular application of 0.1 mL bulk volume (about 66 mg) of the test substance to one eye of three White New Zealand rabbits.

Slight corneal opacity, moderate conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed in the animais during the course of the study. In addition discharge of blood, soleral vesseis injected in a circumscribed area or circular and marginal vascularization of the cornea in a circumscribed area were noted during the observation period.

Considering the described ocular reactions as weIl as the average score tor Irritation, Ammnoniumcarbonat does not show an eye irritation potential under the test conditions chosen.