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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-02-05 - 1998-04-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted on 17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
426-650-9
EC Name:
-
Cas Number:
191743-75-6
Molecular formula:
Unspecified
IUPAC Name:
2-{[4,6-bis({butyl[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]amino})-1,3,5-triazin-2-yl]amino}ethan-1-ol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, PA (on 01/20/98)
- Age at study initiation: Animals were born the weeks 11/09 through 11/23/97, Experimental Start Date: 02/10/98
- Weight at study initiation: 2.0 – 2.5 kg (1 male/ 5 females)
- Housing: 1 animal/sex/cage in suspended wire cage, bedding was changed three times/week
- Diet: Fresh Purina Rabbit Chow, provided daily
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hours dark / 12 hours light
- Animal room was temperature controlled, kept clean and vermin free

IN-LIFE DATES: From: 1998-02-10 To: 1993-02-13

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g, based on the dry weight
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after patch removal
Number of animals:
6 rabbits (1 male, 5 females)
Details on study design:
TEST SITE
- 24 h before: Dorsal area of the trunk of each animal was clipped free of hair
- Area of exposure: approximately 10 x 15 cm
- Test item was placed under a 2.5 x 2.5 cm surgical gauze patch moistened with distilled water
- Gentle pressure was applied to the gauze to aid in the distribution of the test item
- Patch was secured with non-irritating tape
- Type of wrap: Torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test item was gently washed with distilled water from the dose site prior to dermal observations.

OBSERVATIONS
- Duration of observation period following administration: 72 hours
- Test sites were scored for dermal irritation at 30 to 60 minutes post patch removal and again at 24, 48 and 72 hours post patch removal using the numerical Draize scoring code. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
- The general health status of the animals was monitored at each observation time.
- Frequency of weighing: recorded pretest

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Erythema and edema were absent at all observation intervals. The modified Primary Initation Index was 0.
Other effects:
There were no abnormal systemic signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met