Tris(2-hydroxyethyl)-1,3,5-triazinetrione

Skin irritation / corrosion

Administrative data

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:

other: according to information in OECD SIDS (2002)

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2002

Materials and methods

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and for 20 hours usually using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the moistened test substance using cotton patches of this size.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-hydroxyethyl)-1,3,5-triazinetrione

EC Number:

212-660-9

EC Name:

Tris(2-hydroxyethyl)-1,3,5-triazinetrione

Cas Number:

839-90-7

Molecular formula:

C9H15N3O6

IUPAC Name:

tris(2-hydroxyethyl)-1,3,5-triazinane-2,4,6-trione

Details on test material:

- Name of test material (as cited in study report): THEIC
- Physical state: solid
- Analytical purity: ca. 99%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler (breeder)
- Weight at study initiation: 3.14kg and 3.3 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 1 mL (80% aqueous solution) administered using cotton patches of 2.5 x 2.5 cm size.

Duration of treatment / exposure:

Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h

Observation period:

8 days (observations at 1, 3, 4, 7 and 8 days post patch removal)

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure:
An application site of 2.5 X 2.5 cm was covered with the aqueous solution of the test substance (37°C; approx. 1 ml) using a cotton pad of this size.

REMOVAL OF TEST SUBSTANCE

Experiment 1:
Washing of the treated skin in the 1 min, 5 min and 15 min test immediately after the respective treatment period. Concentrated Lutrol (a mild detergent) and a 50% aqueous solution therof was used for washing.

Experiment 2: No washing was done after the 20 h treatment period.

SCORING SYSTEM:
Descriptive grading in the raw data: no effect / questionable / slight / strong / very strong.
In addition, indication of the type of finding as appropriate: erythema / edema / scale formation / necrosis / scar.
The descriptive scores in the raw data were converted into OECD/ Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

after 20 h treatment period

Basis:

animal #1

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Treated skin was not washed after the 20 h treatment period. Skin irritation was evaluated after 24 h and 72 h but not after 48 h.

Results 2

Irritation parameter:

erythema score

Remarks:

after 20 h treatment period

Basis:

animal #2

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Treated skin was not washed after the 20 h treatment period. Skin irritation was evaluated after 24 h and 72 h but not after 48 h.

Results 3

Irritation parameter:

edema score

Remarks:

after 20 h treatment period

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Treated skin was not washed after the 20 h treatment period

Results 4

Irritation parameter:

edema score

Remarks:

after 20 h treatment period

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Treated skin was washed after the 20 h treatment period

Other effects:

No other effects were evident.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating according to EU regulation

Conclusions:

Based on the results of the present study, the test substance has not to be classified as skin irritant following EU CLP requirements. At 48 h post patch removal, skin irritation was not recorded. Nevertheless, in view of only minimal findings at 24 h and the absence of findings at 72 h post patch removal, the study result is fully conclusive regarding classification and labelling according to EU regulations.