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EC number: 212-660-9 | CAS number: 839-90-7
Toxicological information
Skin irritation / corrosion
Currently viewing:
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
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
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
- 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%
Constituent 1
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
Resultsopen allclose all
- 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.
- 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.
- 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
- 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.
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