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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:
20 January 1998 to 06 February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recent EU & OECD test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Reaktivgleb FD 08064

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff® K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (±3°C)
- Humidity (%): 50 (±20%)
- Photoperiod (hrs dark / hrs light): 12 hours daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg applied neat.
Duration of treatment / exposure:
Exposure 24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): isotonic saline at approx. 37 °C
- Time after start of exposure: 24 hours

SCORING SYSTEM: Scale for scoring ocular reactions

TOOL USED TO ASSESS SCORE: fluorescein-sodium solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: Overall after 24, 48 & 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: overall after 24, 48 & 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: overall after 25, 48 & 72 hours
Score:
0.55
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: overall after 24, 48 & 72 hours
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
One and 24 hours after administration the conjunctivae of the animals showed definetely injected blood vessels up to a difuse crimson red color and sporadically very slight up to obvious swellings. Additionally, clear from the substance colored eye discharge was noted. 48 hours after administration the conjunctivae of one animal showed definetely injected blood vessels. 72 hours after administration all signs of irritation were reversible.

Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:

Opacity of cornea all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00

Ins all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00

Redness of
conjunctiva all animals : 0.55
animal 63 : 0.33
animal 64 : 0.33
animal 82 : 1.00

Chemosis of
conjunctiva all animals : 0.11
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.33

Testing of the substance for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
One and 24 hours after administration the conjunctivae of the animals showed definetely injected blood vessels up to a difuse crimson red color and sporadically very slight up to obvious swellings. Additionally, clear from the substance colored eye discharge was noted. 48 hours after administration the conjunctivae of one animal showed definetely injected blood vessels. 72 hours after administration all signs of irritation were reversible.

Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:

Opacity of cornea all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00

Ins all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00

Redness of
conjunctiva all animals : 0.55
animal 63 : 0.33
animal 64 : 0.33
animal 82 : 1.00

Chemosis of
conjunctiva all animals : 0.11
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.33

Testing of the substance for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
Executive summary:

Study conducted to EU test guidance 92/69/EEC part B5 and to OECD test guideline 405 in compliance with GLP.

One and 24 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a difusse crimson red colour and sporadically very slight up to obvious swellings. Additionally, clear from the substance coloured eye discharge was noted. 48 hours after administration the conjunctivae of one animal showed definitely injected blood vessels. 72 hours after administration all signs of irritation were reversible.

Testing of the substance for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.