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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Crude Cyanuric aicd
- Substance type: Solid balls
- Lot/batch No.: 3-30-81

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Isaac’s Farm, Litchfield, Illinois, USA
- Age at study initiation: Young adult
- Weight at study initiation: 2.40 – 2.93 kg
- Diet (e.g. ad libitum): Provided ad libitum
- Water (e.g. ad libitum): Provided ad libitum



Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 82 ± 1 mg


Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
The average of the Draize scores for 24, 48 and 72 h was 0.3.  All irritation had subsided by the third day after exposure.  No corneal or iridal involvement was observed.

Any other information on results incl. tables

Table 1: Primary eye irritation to rabbits - individual irritation scores

Animal number

Observation day

Cornea

Iris

Conjunctivae

Total

Average of 24, 48, 72 h

01M01

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

 

 

 

 

 

 

 

01M02

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

 

 

 

 

 

 

 

01M03

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

 

 

 

 

 

 

 

01F01

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

 

 

 

 

 

 

 

01F02

1

0

0

2

2

0.7

2

0

0

0

0

3

0

0

0

0

 

 

 

 

 

 

 

01F03

1

0

0

2

2

1.3

2

0

0

2

2

3

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cyanuric acid is not irritating to eyes