Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-09-04 to 1984-09-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
-Source: ASTA-Werke AG, Bielefeld
-Age at study initiation: 5 months
-Weight at study initiation: 2 - 2.2 KG
-Housing: single in stainless steel cages
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 2
-Humidity (%): 55 +/- 15
-Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye used as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single application / not rinsed
Observation period (in vivo):
up to 21 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
-Washing: not rinsed

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h to 21 d
Score:
52.9
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h to 21 d
Score:
13.8
Reversibility:
not reversible
Irritant / corrosive response data:
Irreversible serious damage to cornea (partial or total clouding within 1 hour, increasing with time) and iris, permanent conjunctival hyperemia, hypersecretion.
Other effects:
No systemic toxicity

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
Risk of serious damage to eyes
Executive summary:

In this study according to OECD Guideline 405, 3 Albino rabbits were treated with 0.1 g of the test substance. Scoring was done according to Draize and effects were recorded for up to 21 days. The treatment caused irreversible serious damage to cornea (partial or total clouding within 1 hour, increasing with time) and iris, permanent conjunctival hyperemia, and hypersecretion. No systemic toxicity was observed.

In this test chlorhexidine base was judged as corrosive.