Registration Dossier

Administrative data

Description of key information

Two in vivo studies on both skin and eye irritation. Cyanuric acid is non-irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin 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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Isaac’s Farm, Litchfield, Illinois, USA
- Age at study initiation: Young adult
- Weight at study initiation: 2.34 - 3.13 kg
- Diet (e.g. ad libitum): Provided ad libitum
- Water (e.g. ad libitum): Provided ad libitum



Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg

Duration of treatment / exposure:
24 hour(s)
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Dorsal surface
- Type of wrap if used: Latex rubber


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 72 hours


SCORING SYSTEM: Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
Slight irritation to one abraded site of one male animal was observed on the first day after exposure, while skins of the remaining five rabbits remained normal throughout the study.

Table 1: Primary skin irritation to rabbits -Individual irritation scores

Animal number

Period (days)

Erythema

Edema

RFI

LBI

LFA

RBA

RFI

LBI

LFA

RBA

01M01

1

0

0

0

1

0

0

0

0

01M02

1

0

0

0

0

0

0

0

0

01M03

1

0

0

0

0

0

0

0

0

01F01

1

0

0

0

0

0

0

0

0

01F02

1

0

0

0

0

0

0

0

0

01F03

1

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

01M01

3

0

0

0

0

0

0

0

0

01M02

3

0

0

0

0

0

0

0

0

01M03

3

0

0

0

0

0

0

0

0

01F01

3

0

0

0

0

0

0

0

0

01F02

3

0

0

0

0

0

0

0

0

01F03

3

0

0

0

0

0

0

0

0

The primary irritation index for this group of animals is 0.0 on a scale of 0.0 to 8.0. Slight irritation to one abraded site of one male animal was observed on the first day after exposure, while skins of the remaining five animals appeared normal throughout the study. One male rabbit showed slight irritation to one of the abraded sites on one day but the remaining five animals appeared normal throughout the study.

Interpretation of results:
GHS criteria not met
Conclusions:
Cyanuric acid is not irritating
Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
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



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
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.

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

Interpretation of results:
GHS criteria not met
Conclusions:
Cyanuric acid is not irritating to eyes
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In an in vivo skin irritation study (Branch 1990) 500 mg cyanuric acid was applied to the abraded skin of 6 New Zealand White rabbits under an occlusive patch for 24 hours. Animals were observed after removal of the patch up to 72 h. The average of the erythema and edema assessments for the 6 animals after 72 h was 0.0. Cyanuric acid was found to be non-irritating to the skin in rabbits.

 

Eye irritation

In an in vivo eye irritation study (Branch 1981) 82 mg (the 0.1 ml equivalent) of crude cyanuric acid was instilled into the conjunctival sac of albino rabbits. All signs of irritation had subsided by the third day.

Justification for classification or non-classification

In the in vivo skin and eye irritation studies cyanuric acid was non-irritant and therefore requires no classification under DSD or CLP