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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:
January/February 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

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 material form:
solid: particulate/powder
Details on test material:
Basic Violet 16

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Age at study initiation: adult rabbits were used
- Weight at study initiation: 3.6 kg
- Housing: individually in stainless steel cages
- Diet: "Ssniff K" (Ssniff Spezialdiäten GmbH, Soest), ad lib
- Water: tap water was available for ad libitum consultion
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: Jan/Feb 1983

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL pulverized test substance (max 0.1 g)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
All animals showed corneal opacity. About 1 hour after treatment, the cornea surface was dry and dull. Slight irritation of conjunctivae and lachrymation was seen. After 24 hours, no score of 2 or more (erythema, chemosis) or 1 or more (iris) was seen. Two of three rabbits showed mean scores over 24/48/72 h of 2 in corneal opacity, which were still present as score 1 on day 21.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In an acute eye irritation/corrosion study according to OECD 405, the test substance did cause irreversible eye-irritating effects in two of three rabbits.
Executive summary:

In a primary eye irritation study, 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three female New Zealand White rabbits for 24 hours, and subsequently washed out with physiological saline. The animals were observed for a period of 21 days. Irritation was scored by the method by Draize. Based on the results of this study, the test item caused irreversible effects on the eye.