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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no data on test substance purity, test material applied as 10% solution)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(6 animals used, test substance applied as 10% solution, no data on test substance purity)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: clear yellow liquid with slightly sweet odor
- Lot/batch No.: Lot 202

Note: Due to analytical test results the substance is defined as UVCB. For further details see IUCLID Chapter 1.2.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 4 kg (mean)
- Diet: rabbit Altromin 2023 diet, ad libitum
- Water: ad libitum

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

Test system

Vehicle:
water
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10 % (g/g)
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h (all irritation reactions were reversible within 48 h after treatment)
reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: macroscopic

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 36 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The test material did not induce any changes to iris and cornea of test animals. Conjunctivae of test animals showed a slight erythema 1 hour after application. All effects were fully reversible within 48 hours.
Other effects:
4 animals showed a slight exsudation 1 hour after application which was fully reversible within 24 hours.

Any other information on results incl. tables

Table 1. Results of eye irritation study.           
Rabbit # Time [h] conjunctivae   iris cornea   conjunctivae   iris cornea
redness swelling redness swelling    
1 1 2 0 0 0  
24 1 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0 0 0 Time to reversion  48 0 0 0
2 1 2 0 0 0    
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0 0 0 0 Time to reversion  24 0 0 0
3 1 2 1 0 0    
24 1 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0 0 0 Time to reversion  48 24 0 0
4 1 1 0 0 0    
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0 0 0 0 Time to reversion  24 0 0 0
5 1 2 0 0 0    
24 1 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0 0 0 Time to reversion  48 0 0 0
6 1 1 0 0 0    
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0 0 0 0 Time to reversion  24 0 0 0
       
Time [h] conjunctivae   iris cornea
  redness swelling     avg. time to reversion 36 4 0 0
average
score
1 1.67 0.17 0 0  
24 0.50 0 0 0
48 0 0 0 0
72 0 0 0 0
24+48+72 0.17 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified