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Diss Factsheets

Toxicological information

Skin sensitisation

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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:
1997
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

Constituent 1
Chemical structure
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
Constituent 2
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

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 .