Registration Dossier

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:
1991-09-24 to 1991-09-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): T001624
- Physical state: solid
- Appearance: white powder
- CAS: 132961-05-8
- Molecular formula: C23H28F2N4O2
- Molecular weight: 430.5 g/mol
Specific details on test material used for the study:
- Name of test material: T 1624
- Analytical purity: 99.8% (w/w) based on base titration, 101.6% (w/w) based on acid titration
- Lot/batch No.: BEA011
- Storage condition of test material: at room temperature in closed containers

Test animals

Species:
rabbit
Strain:
other: Cunistar-MDL albino rabbits
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: established stock-farm of Buyens, Lichtaart, Belgium
- Age at study initiation: adult
- Weight at study initiation: 2.290 - 2.600 kg
- Housing: Rabbits were housed in an air-conditioned room individually in numbered metallic cages. The cages consisted of stainless steel walls and a wire mesh bottom and front door. The cages were suspended in racks above stainless steel drains with scrapers and sink holes for the collection of faeces and urine.
- Diet: The food consisted of Huybrechts pelleted rabbit food administered in self-raising hoppers and fed ad libitum throughout the study.
- Water: free and continuous access to fresh tap-water via automatic drinking nipples, ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: adjacent areas of the untreated shaved skin serving as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 grams per rabbit
- Concentration (if solution): 50 mg/100 mg


VEHICLE
- Amount(s) applied: no data
- Concentration: no data
- Lot/batch no.: no data
- Purity: no data
Duration of treatment / exposure:
four hours
Observation period:
72 hours (3 days)
Number of animals:
three male rabbits
Details on study design:
TEST SITE
- Area of exposure: about 6 square cm on shaved area of the back
- % coverage: no data
- Type of wrap if used: occlusive patch

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with water, without altering the existing response or integrity of epidermis
- Time after start of exposure: four hours


SCORING SYSTEM:
Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1, 24, 48, and 72 hour readings
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: A score of 0 was observed for all animals and all timepoints.
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1, 24, 48 and 72 hour readings
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: A score of 0 was observed for all animals and all timepoints.
Irritant / corrosive response data:
No irritation was observed in any of the three animals. The erythema and oedema scores at 1, 24, 48, and 72 hours were 0 in all animals.
Other effects:
Body weight remained normal in all rabbits during the 3-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
T 1624, when given to Cunistar-MDL albino rabbits at a single dose of 0.5 g/rabbit by dermal application, produced no dermal irritation. Therefore, the testitem should be considered not to be classified.