Registration Dossier

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:
Between 2000-09-25 and 2000-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP test following OECD test guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

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 (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran
EC Number:
251-090-5
EC Name:
3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran
Cas Number:
32539-83-6
Molecular formula:
C15H26O1
IUPAC Name:
2H,3H,4H,5H,6H,7H,8H,9H,10H,11H,12H,13H,14H-cyclododeca[b]pyran
Details on test material:
- Name of test material (as cited in study report): HR 00/690946
- Substance type: active
- Physical state: liquid
- Lot/batch No.: 20081508
- Expiration date of the lot/batch: 360 days
- Stability under test conditions: yes
- Storage condition of test material: cool and dry

Test animals

Species:
rabbit
Strain:
other: Chbb:HM(SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, DE-88397 Biberach
- Weight at study initiation: 2.8-3.0 kg
- Housing: rabbits caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet (e.g. ad libitum): ad libitum "Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water acidified with hydrochloric acid (pH 2.5) in order to prevent microbial growth
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): animals where in a room with filtered air
- Photoperiod (hrs dark / hrs light): 12 hours light (6 a.m. to 6 p.m.) and 12 hours darkness

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Ethanol/Diethylphthalat: 1:1
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of test article or vehicle
- Concentration (if solution): 1 %, 10 %, 25 %, 50 % and 100 %


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
skin reactions were read one hour, 24, 48 and 72 hours as well as 7, 14 and 21 days after termination of exposure
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 10*10 cm on the back
- % coverage: no data
- Type of wrap if used: layer gauze patches


REMOVAL OF TEST SUBSTANCE
- Washing (if done): mild soap and lukewarm water


SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in the depth): 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Well-defined oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm, extending beyond area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema-formation
Basis:
mean
Time point:
other: mean individual scores 24, 48 and 72 hours-reading
Score:
> 0 - < 2.8
Max. score:
2.8
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean individual scores 24, 48 and 72 hours-reading
Score:
>= 0 - <= 2.8
Max. score:
2.8
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
plese, see the tables in "Attached background materials"
Other effects:
no effects

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the directive of the 98/98/EEC the test material in concentrations 100 % and 50 % shall be classified as skin irritating.
According to the directive of the 98/98EEC the test material in concentrations 25 %, 10 % and 1% shall not be classified as skin irritating.
Executive summary:

According to the directive of the 98/98/EEC the test material in concentrations 100 % and 50 % shall be classified as skin irritating.

According to the directive 98/98/EEC the test material in concentrations 25 %, 10 % and 1% shall not be classified as skin irritating.