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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-05-25 - 1994-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The GLP study was conducted according to an internationally accepted guideline (OECD 405). All study parameters are based on the specific guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-Triazine-2,4,6-triamine, deammoniated
EC Number:
272-034-6
EC Name:
1,3,5-Triazine-2,4,6-triamine, deammoniated
Cas Number:
68649-66-1
Molecular formula:
see structural formula below
IUPAC Name:
1,3,5-Triazine-2,4,6-triamine, deammoniated

Test animals / tissue source

Species:
rabbit
Strain:
other: White russian (Albino)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
44.7 - 49.3 mg (representing a volume of about 0.1 ml)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
After grinding in a ball mill 44.7 - 49.3 mg (representing a volume of about 0.1 ml) of the powdered test substance were applied into the conjunctival sac of the left or right eye. Then both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control. The treated eye was not rinsed. The treated eye was examined using a Cliptrix pencil light (supplied by Varta, D-30419 Hannover, No. 645). Signs of irritation on the cornea, iris, and conjunctiva were assessed quantitatively and qualitatively using the DRAIZE scale (1, 2, 4, 5). In addition, attention was paid to the occurrence of further reactions on the eye (e.g. corrosive effects) and to clinical symptoms (systemic toxic effects).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
2
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Durferrit REG 1 was tested for eye irritating properties in the rabbit eye.
Observed eye lesions included hyperemia, diffuse redness, slight discharge or discharge with moistening of lids and hair. The symptoms were fully reversible after 48 hours. It is concluded that REG 1 is non-irritant to the eyes of the rabbit.
Executive summary:

Durferrit REG 1 was tested for eye irritating properties in the rabbit eye. Observed eye lesions included hyperemia, diffuse redness, slight discharge or discharge with moistening of lids and hair. The symptoms were fully reversible after 48 hours. It is concluded that REG 1 is non-irritant to the eyes of the rabbit.