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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye 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-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: Annex V Part B, B5 Acute toxicity-Eye irritation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
not available
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
source Broekman Institute, Someren , The Netherlands
Number of animals 3 male rabbits
Age of start of treatment Approx. 8 or 10 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

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye served as control
Amount / concentration applied:
100.3 plus minus 0.3 mg
Duration of treatment / exposure:
72 hr
Observation period (in vivo):
Mortality/Viability Twice daily
Toxicity At least once daily
Body weight Day of treatment (prior to instillation)
Irritation The eyes of each animal were examined approx. 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
See attached file on study design (treatment)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: eyelids, Nictitating membrane, Sclera
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 1 hr
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Sclera
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 1 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Eyelids, Nictitiating membrane, Sclera
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Eyelids
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 24 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Sclera
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Sclera
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hr, 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Nictitating membrane
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 hr, 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, animal # 2, animal # 3
Time point:
other: 1 hr, 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1, animal #2, animal # 3
Time point:
other: 1 hr, 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Irritation Instillation of approx. 100 mg of SR-245 (maximum required amount) into one eye of each three rabbits resulted in irritation of the conjunctivae, which consisted of redness and/or chemosis. Changes were fully reversible within 2 days
Corrosion No evidence of ocular corrosion
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
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 Eye irritation.