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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:
15.05 - 23.05.2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbits of the stock Chbb:HM(SPF) - Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.8 - 3.0 kg b.w.
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% + 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): Light was on from 6 a.m. to 6 p.m..

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of undiluted test item
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 20 ml 0.9% sodium chloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: See 'Any other information on materials and methods'

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Animals 1 and 4 showed markedly deepened folds, congestion, swelling, moderate circumcorneal injection, reaction to light, some injection of conjunctival vessels and discharge different from normal 1 hour after application. Animal 2 showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as obvious swelling with partial eversion of lids. Animal 3 showed some conjunctival vessels definitely injected, swelling with partial eversion of lids and discharge different from normal.
24 hours after application animals 1 and 2 showed some conjunctival vessels definitely injected and swelling above normal. Animals 3 and 4 showed diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as obvious swelling with partial eversion of lids.
48 hours after application all animal showed some injected conjunctival vessels and animals 2, 3 and 4 showed additionally swelling above normal.
72 hours after application animals 3 and 4 showed some injected conjunctival vessels and swelling above normal. Animals 1 and 2 were free of any signs of eye irritation.
7 days after application all animals were free of any signs of eye irritation.

Any other information on results incl. tables

Individual irritation scores

Animal n°

Cornea opacity

Iris lesion

Redness of conjunctiva

Oedema of conjunctiva

1

0.00

0.00

0.67

0.33

2

0.00

0.00

0.67

0.67

3

0.00

0.00

1.33

1.33

4

0.00

0.00

1.33

1.33

Mean values

0.00

0.00

1.0

0.9

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item shall not be classified as eye irritating.
Executive summary:

The objective of this study was to assess the potential eye irritant effect of the test substance according to the method in the OECD Guideline 405 and EEC Guideline B.5.

The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal three other rabbits were included in the study with time difference.

The female albino rabbits were exposed to 0.1 ml of the test article in the left eye while the right eye served as control. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7 days after dosing.

Slight to well-defined signs of irritation were observed in the treated eyes, however, all effects were fully reversible within 7 days.

The following mean values for all animals, based an the results from the 24, 48 and 72 hour readings, were calculated:

- cornea opacity score: 0.0

- iris score: 0.0

- conjunctivae score: 1.0

- chemosis score: 0.9

According to the CLP regulation, the test item shall not be classified as eye irritating.