Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
solid

Test animals

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

Test system

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:

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.