Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with the OECD Guideline for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion", and the conditions of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
EC Number:
239-707-6
EC Name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
Cas Number:
15630-89-4
Molecular formula:
CH2O3.3/2H2O2.2Na
IUPAC Name:
disodium carbonate, compound with hydrogen peroxide (2:3)
Details on test material:
- Name of test material (as cited in study report): Sodium carbonate peroxyhydrate
- Analytical purity: > 88 %
- Source: Solvay Interox SA

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, UK
- Age at study initiation: 12-17 weeks
- Weight at study initiation: 2.78

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 mg of grounded, fine powder of sodium percarbonate was instilled into the eye
Duration of treatment / exposure:
5 h without rinsing
Observation period (in vivo):
1 and 5 h
Number of animals or in vitro replicates:
1
Details on study design:
The irritating effect to the eye was scored following the method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #1
Time point:
other: 1 hour
Score:
59
Remarks on result:
probability of severe irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #1
Time point:
other: 5 hours
Score:
61
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
Translucent corneal opacity, iridial inflammation and moderate to severe conjunctival irritation.
Other effects:
Petechial haemorrhage of the nictitating membrane and haemorrhage of the conjunctival membrane and nictitating membrane.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
Sodium percarbonate was classified as highly irritating to the eye.
Executive summary:

The eye irritation potential of sodium percarbonate was tested in one male New Zealand White rabbit according to the OECD Guideline No 405 and to GLP. 100 mg of undiluted test material was instilled into the right eye of the animal and reaction was observed and scored following the Draize method after 1 and 5 hours.

The total maximum irritation score after 1 hour was 59 and after 5 hours was 61, and the test was stopped after 5 hours without a reversibility phase. Thus, sodium percarbonate was classified as highly irritating to the eye.

Categories Display