Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other 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: EC council directive 67/548/EEC Annex V Part B B4 Acute toxicity-skin irritation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
not relevant
GLP compliance:
yes

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
source Broekman Institute, Someren , The Netherlands
Number of animals 3 male rabbits
Age of start of treatment Approx. 8 weeks
Identification Ear tag
Husbandary:
Air conditioned room with approx 15 air changes/hr
Temp: 21 Deg C.
RH: 50%
Light: 12 hr artificial light 12 hr dark.
Accommodation: Individually in labelled cages
Acclimatisation period was at least 5 days before start of the treatment
Diet Standard pelleted laboratory rabbit diet
Water Free access to tap water diluted with decalcified water

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The substance was moistened with distilled water.
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
Mortality/Viability Twice daily
Toxicity At least once daily
Body weight Day of treatment (prior to application)
Irritation The skin reactions were assessed at approx. 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
The skin reactions were graded according to numerical scoring system.
Number of animals:
3 male rabbits
Details on study design:
See attached document on study design (treatment)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Irritation No skin irritation was caused by 4 hr exposure to SR-245
Corrosion There was no evidence of a corrosive effect on the skin
Colouration No staining of the treated skin by the test substance was observed
Toxicity/Mortality No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred
Other effects:
None

Any other information on results incl. tables

See attached document on tables and figures

Applicant's summary and conclusion

Conclusions:
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), FR-245 does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

n/a