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EC number: 426-040-2 | CAS number: 25713-60-4 SR-245
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: method B6 of commision directive 92/69/EEC(Annex V of Council directive 67/548/EEC)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Not available
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The original Test Guideline (TG) for the determination of skin sensitization in the mouse, the Local Lymph Node Assay (LLNA; TG 429) was adopted in 2002. The cited study was performed in 1997.
Test material
- Reference substance name:
- 2,4,6-tris(2,4,6-tribromophenoxy)-1,3,5-triazine
- EC Number:
- 426-040-2
- EC Name:
- 2,4,6-tris(2,4,6-tribromophenoxy)-1,3,5-triazine
- Cas Number:
- 25713-60-4
- Molecular formula:
- C 21 H 6 Br 9 N 3 O 3
- IUPAC Name:
- tris(2,4,6-tribromophenoxy)-1,3,5-triazine
- Reference substance name:
- 4260402
- IUPAC Name:
- 4260402
- Details on test material:
- Identification SR-245
Description White powder
Batch 969066
Purity 100%
Test substance storage At room temperature in the dark
Stability under storage conditions Stable
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan strain, albino guinea pig
- Sex:
- female
- Details on test animals and environmental conditions:
- Source BRL Ltd. Basel, Switzerland
Age Young adult animals (approx. 6-7 weeks old)
Body weight Group mean <500gram; Individually ≤ 538 grams
Identification Ear tattoo
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and epidermal
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 5% in corn oil
b) Topical: 50% in corn oil
Concentration of test material and vehicle used for each challenge:
50% in corn oil
Challengeopen allclose all
- Route:
- other: intradermal and epidermal
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 5% in corn oil
b) Topical: 50% in corn oil
Concentration of test material and vehicle used for each challenge:
50% in corn oil
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- See attached document study design
- Challenge controls:
- See attached document on study design
- Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamic Aldehyde, Tech 85%
Results and discussion
- Positive control results:
- see attached document on summary of positive control experiment
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
As no signs of irritation were observed with 50% test
substance, a 10% solution of sodium lauryl sulphate was
applied prior to topical induction.
Evidence of sensitisation of each challenge concentration:
1/18
Other observations:
The main study was initiated by treatment of a group of 10
experimental and 5 control animals. A second group of 10
experimental and 5 control animals was identically treated
one week later, since two experimental animals of the first
group died.
Signs of ill health, deep respiration, dark eyes, weakness,
were observed on the day prior to death of one animal.
Macroscopic post mortem examination of both aimals showed
dark red (spotted) discoloration of the lungs. It was
considered that the death of these animals was incidental
and probably related to stress.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- results indicate a sensitisation rate of 0-6%. For calculation of this result, all surviving animals of the first and second group were taken into
account (18 experimental and 10 control animals).
Based on these results and according to the EEC criteria for classification and
labelling requirements for dangerous substances and preparations (Guidelines in
Commission Directive 93/21/EEC, 27th April 1993), SR-245 does not have to be
classified and has no obligatory labelling requirement for sensitisation by skin
contact .
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