Reaction mass of L-xylo-hex-2-ulosonic acid and ascorbic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5,6-Tetrahydroxy-2-oxo-hexanoicacid

IUPAC Name:

3,4,5,6-Tetrahydroxy-2-oxo-hexanoicacid

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino rabbit; Crt: KBL (NZW) BR

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, KiBlegg
- Age at study initiation: 14 weeks
- Weight at study initiation: 3.05 kg
- Housing: The animals were housed in air conditioned rooms at the Institute of Toxicology.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 59-75%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: June 5, 1997 To: July 17, 1997

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eye was examined after 1 hour of treatment, 24, 48, 72 hours and then daily up through day 22 of the experimental part. Body weight was recorded on day 1 and also on days 5, 8, 11, 15, and 22.

Number of animals or in vitro replicates:

1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

3.75

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Remarks on result:

other: The iris was not visible up to day 5

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

1.25 - 2.25

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is considered to be an eye irritant for regulatory purposes. The weight of the rabbit increased from 3.05 kg to 3.51 over the course of the study period.

Executive summary:

This study examined the potential of the test substance to cause irritation to eyes. 0.1 g of test substance was placed in one eye of one female rabbit. The untreated eye served as control. The animals were examined for signs of irritation at 1, 24, 48, and 72 hours, as well as daily up until day 22 after application. The mean score for the cornea was 3.75, while the mean score for the iris was not determined as it was not able to be seen until day 5 of the study. The mean conjunctivae scores were 1.25 and 2.25 for A and B, respecitively. The test substance is classified as an eye irritant under EU GHS guidelines.