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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:
30.6.1988-3.7.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was preformed according to a EU guideline study with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
84/449/EEC
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzoguanamine; 2,4-Diamino-6-phenyl-1,3,5-triazine
- Physical state: colourless crystals
- Analytical purity: 99.2%
- Lot/batch No.: 120488 BG
- Stability under test conditions: stable under conditions of storage
- Storage condition of test material: at room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, NL
- Age at study initiation: approx. 18 weeks
- Weight at study initiation: animal #1 (4545-F): 3520 g; animal #2 (4561-F): 3503 g; animal #3 (4575-F): 3470 g
- Housing: individual housing in a plastic cage with perforated floor
- Diet (e.g. ad libitum): 100 g/day LKK-20, diameter 4 mm
- Water (e.g. ad libitum): free access to tap-water (via automatic nozzles)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20 °C
- Humidity (%): 65-80 %
- Air changes (per hr): no information available
- Photoperiod (hrs dark / hrs light): 12 h light, 12 h dark

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
test substance was ground to a fine powder
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Three potions of 94±2 mg of the test substance were dispensed in glass containers with screw caps. Each potion was instilled in the conjunctival sac of the right eye of each animal using a spatula. The lids were then held gently together for two seconds and released. Immediately after treatment, the animals were transferred to their cages.
Observation period (in vivo):
72 h; examinations after 60 min, 24, 48, and 72 hours
Number of animals or in vitro replicates:
three female rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 60 mins
Score:
4
Max. score:
6
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible

Any other information on results incl. tables

No adverse effects on the cornea and the iris were observed in any of the rabbits during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any corneal epithelial damage. No signs of systemic intoxication were observed in any of the rabbits.

Approx. 60 minutes after exposure slight chemosis in animal #2 and #3 were observed which resolved within 24 hours.

 Animal No.    1 hour  1 day 2 day  3 day 
 #1 Cornea 
  Iris 
  Conjunctivae 
  Subtotal 
 #2 Cornea  0
  Iris 
  Conjunctivae  
  Subtotal
 #3 Cornea 
  Iris
  Conjuntivae
  Subtotal
  Total 12 
  Mean total 4.0  2.0  1.3 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The presented guideline study is reliable and adequate for the chemical safety assessment of 6-phenyl-1,3,5-triazine-2,4-diyldiamine.
The fully reversibility of the chemosis within 24 hours indicates only mechanical irritation. The data are conclusive but not sufficient for classification according to Regulation Regulation (EC) No 1272/2008.