Registration Dossier

Administrative data

Description of key information

skin: rabbit, occlusive, 4h: not irritating (84-0187-DKT)
eye: rabbit, 0.1 mL, eye not rinsed: not irritating (85-0201-DKT)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported
GLP compliance:
no
Remarks:
test was performed prior to GLP-requirement
Species:
rabbit
Strain:
other: White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld
- Age at study initiation: 4-6 months
- Weight at study initiation: 1.95-2.2 kg
- Housing: individually stainless steel cage type Asta
- Diet: ssniff, no further data
- Water: ad libitum
- Acclimation period: 1 day, in-house breeding


ENVIRONMENTAL CONDITIONS according to guideline
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: control patches without test substance
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted, 30°C warm to reduce viscosity

Duration of treatment / exposure:
4 h
Observation period:
1 h, 24h, 48 h and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal between shoulder and sacral region
- % coverage: 4 patches 6.25 cm² / patch
- Type of wrap if used: Acrylastic



SCORING SYSTEM: according to guideline
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
no findings
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Classification: not irritating
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported
GLP compliance:
no
Remarks:
test was performed prior to GLP-requirement
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG
- Age at study initiation: approx. 6 months
- Weight at study initiation: 2.15-2.25 kg
- Housing: individually Stainless steel cage type ASTA
- Diet: ssniff K
- Water: tap water ad libitum
- Acclimation period: 1 day, in-hose breeding


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL prewarmed to 30°C
Duration of treatment / exposure:
single treatment, eye not rinsed
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Other effects:
The test substance caused hypersecretion of the eye in all 3 animals 1 h p.a. but was reversible within 24 h.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no irritation when applied on the rabbit eye mucosa. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritiation/corrosion:

Triallyl cyanurate was tested for acute dermal irritation/corrosion in a GLP-guideline study similiar to OECD Guideline 404 (84 -0187 -DKT). 0.5 mL of the test substance was applied under occlusive conditions in a single dose to the clipped skin of 3 White Russian rabbits for 4 hours. No erythema or oedema formations were observed after patch removal and reading time points 24, 48 and 72 hours. No systemic toxic effects could be detected.

Eye irritation:

The acute eye irritation of triallyl cyanurate was investigated in a GLP-guideline study similar to OECD Guideline 405 in the rabbit (85 -0201 -DKT). A 0.1 mL aliquot of triallyl cyanurate was introduced into the right eye of a total of 3 female Himalayan rabbits (no washout). The left eye, which remained untreated, served as control. No irritating reactions on cornea, iris, conjunctiva redness and chemosis caused by the substance were examined at all reading time points (24, 48 and 72 hours). Systemic toxic effects could not be detected.

The non-irritating effect to the eye was confirmed by Vernon et al. (1990).


Justification for selection of skin irritation / corrosion endpoint:
Only one valid study available.

Justification for selection of eye irritation endpoint:
Most valid study available.

Justification for classification or non-classification

Neither skin nor eye irritation was observed after exposure to triallyl cyanurate. Thus, no skin or eye irritant classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC)