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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:
28 Aug 2000 - 8 Nov 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:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
Stock/Breeder: LPT Laboratory of Pharmacology and Toxicology KG, branch Lohndorf, D-24601 Lohndorf/Post Wankendorf
Sex: male
Age: 8.5-9mos
Weight: 2.7 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
Examined at 60 min, 1, 24, 48, 72 hours, daily from day 4-21
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
4
Max. score:
4
Reversibility:
other: further assessment not possible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
other: further assessment not possible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Cornea: Grade 4 opacity was observed at 1 hour after application. Further assessment was not possible: whitish deposits (probably pus) were seen from 72 hours and eyelids sticking together from day 5 after application onwards. The cornea was completely destroyed by day 18 after treatment.
Iris: Grade 2 irritation of the iris was observed at 1 hour after application. Further assessment of the iris was not possible.
Conjunctiva:
Redness: Grade 1-2 conjunctival redness was seen during the complete observation period except for days 5-17, where no assessment was possible.
Chemosis: Grade 3-4 conjunctival chemosis was seen between 1 hour and 18 days after application. Afterwards grade 2 chemosis was observed.
Other effects:
Systemic intolerance reactions were not observed.

Any other information on results incl. tables

 

Cornea

Iris

Conjunctiva

redness

chemosis

score (average of animals investigated)

0 to 4

0 to 2

0 to 3

0 to4

60 min

4

2

2

3

24 h

n.p.

n.p.

1

3

48 h

n.p.

n.p.

1

3

72 h

n.p.

n.p.

2

4

Average 24h, 48h, 72h

n.p.

n.p.

1.3

3.3

Day 21

Cornea destroyed

-

1

2

Area effected

Not reported

Maximum average score (including area affected, max 110)

-

-

-

-

Reversibility*

n

n

n

n

average time for reversion

-

-

-

-

 

*            c :          completely reversible
              n c :      not completely reversible
              n :         not reversible

-

-

-

-

n.p. = assessment not possible

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Reactions in the cornea, iris and the conjunctiva revealed severe irritation of the eye. The cornea was completely destroyed by day 18 after treatment. Eye reactions were not reversible within 21 days after application.