Registration Dossier

Administrative data

Description of key information

Skin irritation was tested with rabbits and the substance is described as not irritating. Eye irritation was tested with rabbits and the substance is described as slightly irritating. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21.06.1988-24.06.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline study with GLP compliance.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, NL
- Age at study initiation: 4575-F (animal #1): 22 weeks, 4625-F (animal #2): 17 weeks, 4629-F (animal #3): 17 weeks
- Weight at study initiation: 4575-F: 3551 g, 4625-F: 3073 g, 4629-F: 2831g
- Housing: individual in plastic cage with perforated floor
- Diet (e.g. ad libitum): 100 g LKK-20, diameter: 4 mm
- Water (e.g. ad libitum): free access to tap water (via automatic nozzles)
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 55-75 %
- Air changes (per hr): no information available
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g of test substance were moistened with 0.3 mL Milli-RO water. Each portion of the test substance was spread on a 6 cm^2 patch of Metalline and mounted on permeable tape. This was applied to the left flank of each animal, the right flank was being covered without test substance.
Duration of treatment / exposure:
Animals were wrapped in flexible bandage for 4 hours after which period the remaining test substance was removed using dry tissue and subsequently a tissue moistened with tap-water.
Observation period:
60 min, 24 h, 48 h, and 72 h after removal of the patches.
Number of animals:
three female rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 cm^2
- % coverage:
- Type of wrap if used: flexible bandage (Coban, 3M, St. Paul, USA)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): dry and moistened tissue
- Time after start of exposure:

SCORING SYSTEM:
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Remarks on result:
other: no adverse effects to skin were observed
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 24 h
Score:
0
Remarks on result:
other: no adverse effects to skin were observed
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 24 h
Score:
0
Remarks on result:
other: no adverse effects to skin were observed
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no adverse effects to skin were observed
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no adverse effects to skin were observed
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no adverse effects to skin were observed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The presented guideline study is reliable and adequate for the chemical assessement of 6-phenyl-1,3,5-triazine-2,4-diyldiamine. Based on the observations of the study the test substance is classified as non irritating to skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
84/449/EEC
GLP compliance:
yes
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
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
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
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

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 
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritation test [Daamen, P.A.M. (1988a)] was identified as key study because it was well conducted and described in detail.

In this study the substance was studied for skin irritation in rabbits. The substance was applied to the skin with patches for 4 hours by three female rabbits. The animals were observed at 1h, 24h, 48h and 72 h after removal of the patches. During the observation period no adverse effects to skin were observed.

Due to the result of the test, the substance is classified as not irritating to skin.

The eye irritation study [Daamen, P.A.M. (1988b)] was identified as key study because it was well conducted and described in detail.

In this study the substance was studied for eye irritation in rabbits. The substance was dispensed, in the conjunctive sac of one eye of three female rabbits using a spatula. The animals were examined at 1h, 24h, 48h and 72 h after treatment.

No adverse effects on the cornea and the iris were observed in any of the rabbits during the entire observation period. No signs of systemic intoxication were observed in any of the rabbits. Approx. 60 minutes after exposure slight chemosis in two animals were observed which resolved within 24 hours.

In the line with the result the substance is described as slightly irritant but not sufficient for a classification according to Regulation (EC) No. 1272/2008.


Justification for selection of skin irritation / corrosion endpoint:
The study was performed according to OECD guideline study with Klimisch score 1.

Justification for selection of eye irritation endpoint:
The study was performed according to EU guideline study with Klimisch score 1.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The presented data for skin and the eye irritation are reliable and adequate guideline studies. The observations within these studies are conclusive but not sufficient for a classification according to Regulation (EC) No. 1272/2008.