glyoxal … %; ethandial … %

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

volume of 0.05 mL applied (OECD: 0.1 mL); 2 animals used (OECD: 3); observation period was 8 days (OECD: 21); examination using fluorescein (OECD: no use of fluorescein)]

Principles of method if other than guideline:

The test was conducted according to an internal BASF test method, which in principle was similar to OECD 404.
BASF-TEST:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 µl of the test substance were applied to the conjunctival sac of one eye of each of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test material

Test material information

Constituent 1

Reference substance name:

Glyoxal

EC Number:

203-474-9

EC Name:

Glyoxal

Cas Number:

107-22-2

Molecular formula:

C2H2O2

IUPAC Name:

oxalaldehyde

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

Two animals, a male and a female, were used; each animal weighed about 2 kg.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of each animal served as control

Amount / concentration applied:

ca. 0.05 mL of undiluted test material was instilled in the conjunctival sac of the right eye of each animal.

Duration of treatment / exposure:

Not applicable as the test substance was not washed out.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

Two animals were used

Details on study design:

- Following application, the animals were examined for corneal changes, iris effects and conjunctival reaction at following reading time points: 1, 24, 48 hours and at day 8;
-The eye findings, which had been originally scored according to a BASF scoring system;
- For evaluation, the BASF scores given in the raw data were converted into Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

> 1 - <= 3

Reversibility:

not fully reversible within: 8 days

Remarks:

opacity grade 1

Remarks on result:

other: glyoxal pure, glyoxal crude

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: glyoxal pure, glyoxal crude

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

> 3 - <= 4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: glyoxal pure, glyoxal crude

Any other information on results incl. tables

- After instillation of pure Glyoxal, a slight corneal opacity was observed up to reading time point 72 hours, thereafter, corneal opacity was no longer observed. Technical grade Glyoxal induced cloudy to milky corneal opacity that still was evident on day 8, even though having turned into slight opacity.

- Glyoxal pure and Glyoxal technical grade instilled unchanged into the conjunctival sac caused a clear reddening and very strong inflammation on the conjunctiva.

- No effects were seen in the iris.

- Referring to reversibility, at day 8 post treatment, slight reddening and chemosis were still seen in the eyes treated with pure Glyoxal whereas the eyes treated with the technical grade material showed slight reddening, slight chemosis (one of the two animals treated), slight corneal opacity and scarification of the upper eyelid.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria