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Diss Factsheets

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:
March 1994
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
421-450-8
EC Name:
-
Cas Number:
154702-15-5
Molecular formula:
C44H59N7O5
IUPAC Name:
2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
Details on test material:
- Name of test material (as cited in study report): ra 3643 bxa
- Substance type: white powder
- Physical state: solid
- Expiration date of the lot/batch: January 4, 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
3 males
- Source: Conelli snc Arona (Novara) Italy
- Age at study initiation: 2-3 months
- Weight at study initiation: 2-3 kg
- Diet (e.g. ad libitum): GLP 2 RB 15 certificate pelletted diet; the content were crude protein (13.2%), crude fat (2.5%, crude fiber (22%),l crude ash (9.5%). The diet was supplemented with vitamins and trace elements. The diet was available ad libitum.
- Water (e.g. ad libitum): from the municipal water main system. Ad libitum.
- Acclimation period: about 10 weeks

ENVIRONMENTAL CONDITIONS
individual caging in T07C air conditioned room
- Temperature (°C): 20°C +/- 2
- Humidity (%): 50+/- 15
- Air changes (per hr): about 15/hour
- Photoperiod (hrs dark / hrs light): artificial lighting with a circadian cycle of 12 hours of light (7am-7pm)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: fur was clipped with care to not abrade the skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g/animal
Duration of treatment / exposure:
3 minutes, 1 and 4 hours
Observation period:
immediately after the 3 minutes and the 1 hour-exposure periods and at 72 hours in the first rabbit, and at 1,24,48 and 72 hours after the 4-hours exposure period (all rabbits).
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure:6 cm2
- Type of wrap if used: gauze patch; impermeable, non-irritant, hypoallergenic tape

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable - no irritation noted
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable - no irritation noted
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable - no irritation noted
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable - no irritation noted
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable - no irritation noted
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable - no irritation noted

Any other information on results incl. tables

No animal died.

No clinical signs or behavioral alterations were noted.

No signs of dermal irritancy were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is to be considered not irritant for the skin.