Registration Dossier

Administrative data

Description of key information

The irritation potential of Tris(2-hydroxyethyl) isocyanurate triacrylate was evaluated in rabbit's studies.

Based on the available data, Tris(2-hydroxyethyl) isocyanurate triacrylate is not irritating for skin but severely irritating (corrosive) to the eyes.

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
Study period:
January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13-19 weeks if age
- Weight at study initiation: 2.9-3.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g of the test substance was applied under a 25 mm x 25 mm gauze pad moistened with 0.5 ml distilled water to one intact skin site of each animal
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3
Details on study design:
The test substance was administered following grinding using a pestle and mortar.
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water ( 30°C to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
All animals were observed daily for signs of ill health or toxicity.
Dermal examination of the treated skin was made on Day 1 (60 minutes after removal of the dressings) and on Days 2, 3, and 4 (equivalent to 24, 48 and 72 hours after exposure).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal irritation was observed at 60 min, 24h, 48h and 72h after patch removal.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
GHS criteria not met
Remarks:
: Not skin irritating
Conclusions:
A single semi-occlusive application of the test substance to intact rabbit skin for 4h elicited no dermal irritation.
Executive summary:

A study was performed to assess the skin irritation potential of the test item to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No dermal reactions were observed following a single semi-occlusive dermal application of the test substance to intact rabbit skin for four hours. Based on these results, the test substance is considered as not skin 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
Study period:
January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13 weeks if age
- Weight at study initiation: 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were ten gently held together for one second before releasing. The contralateral eye remained untreated.
Duration of treatment / exposure:
1 h
Observation period (in vivo):
1 hour and 1 day after exposure
Number of animals or in vitro replicates:
1 animal
Details on study design:
The eyes were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated initially, to ensure that if a severe response was produced, no further animals would be exposed. On this occasion, due to the severity of the reactions, no further animals were used.
The animal was observed daily for signs of ill health or toxicity.
Examination of the eyes was made after 1 hour and on two occasions one day after instillation. Observation of the eyes was aided by the use of a handheld light.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with necrosis and haemorrhage
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with nictating membrane swollen
Irritant / corrosive response data:
Corneal opacities developed one day after instillation.
Iridial inflammation (grade 2) was observed.
A diffuse crimson or beefy red colouration of the conjunctivae accompanied by swelling with the eyelids more than half closed was seen. Necrosis and haemorrhage was seen on the nictating membrane and lower eyelid. A red/brown discharge was also seen before the animal was killed.
Due to the severity of the reactions, the animal was killed one day after instillation and no further animals were treated.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the available results, the test substance is considered as severely eye irritating to the rabbit.
Executive summary:

A study was performed to assess the eye irritation of the test substance to the rabbit. One rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation study in rabbit (1994)

A study was performed to assess the skin irritation potential of the test item to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No dermal reactions were observed following a single semi-occlusive dermal application of the test substance to intact rabbit skin for four hours. Based on these results, the test substance is considered as not skin irritating.

Eye irritation study in rabbit (1994)

A study was performed to assess the eye irritation of the test substance to the rabbit. One rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.

Justification for classification or non-classification

Based on the rabbit's studies, Tris(2-hydroxyethyl) isocyanurate triacrylate should be classified as Eye Dam.1 (H318) according to the Regulation EC no.1272/2008. No classification is required for skin irritation.