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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individually in stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Ssniff K 4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: Oct. 19, 1992 To: Oct. 26, 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye was used as control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:

24 hrs
Observation period (in vivo):
Readings were taken at 1, 24, 48, and 72 hours, and 6 days after the application.
Number of animals or in vitro replicates:
3
Details on study design:
A single application to the conjunctival sac of the right eyelid. The substance was not washed out.

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: fluorescein stain

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
0.55
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
All three animals exhibited conjunctival erythema (score of 1) at the 1 hr reading and through the 24 hr reading. By the 48 hr reading, these symptoms had resolved in all but one animal. This animal continued to show conjunctival erythema through the 72 hr reading, but by the day 6 reading, its symptoms had resolved as well.

Any other information on results incl. tables

Results of Eye Irritation Study

Animal

1 hr

24 hr

48 hr

72 hr

6 days

1

Conjunctiva - Erythema

1

1

1

1

0

Conjunctiva ¿ Chemosis

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

0

0

0

0

0

2

Conjunctiva - Erythema

1

1

0

0

0

Conjunctiva ¿ Chemosis

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

0

0

0

0

0

3

Conjunctiva - Erythema

1

1

0

0

0

Conjunctiva ¿ Chemosis

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not classified as an eye irritant according to EU GHS guidelines.
Executive summary:

This study examined the potential of the test substance to cause irritation to eyes. 0.1 ml of test substance was placed in one eye of three male rabbits. The untreated eye served as control. The animals were examined for signs of irritation at 1, 24, 48, and 72 hours after application. All three animals showed signs of conjunctival erythema (score of 1) at the 1 hr observation. By the 48 hr observation, these symptoms had resolved in all but one animal. This animal continued to show irritation at the 72 hr observation. For this reason, the study was extended to determine the reversibility of the symptoms. At the next observation at day 6, symptoms had resolved in all animals. The mean irritation score was 0.55. The test substance is not classified as an eye irritant under EU GHS guidelines.