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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:
1988-07-26 - 1988-08-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well-documented study conducted under GLP according to OECD guideline 404 on the registered substance itself without deviations.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin
EC Number:
277-633-6
EC Name:
4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin
Cas Number:
73912-21-7
Molecular formula:
C27H35O3P
IUPAC Name:
7,13-dicyclohexyl-5,15-dimethyl-9,11-dioxa-10-phosphatricyclo[10.4.0.0³,⁸]hexadeca-1(12),3(8),4,6,13,15-hexaen-10-ol
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12Hdibenzo[d,g][1,3,2]dioxaphosphocin

Test animals

Species:
rabbit
Strain:
other: HC:NZW Albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: adult
- Weight at study initiation: 3.0 - 3.7 kg
- Housing: individually in wire cages Type III-high with bedding of dust-free wood granulates Type S 8/15 (Ssniff, Hoechst)
- Diet (e.g. ad libitum): Standard diet ssniff K 4 (Ssniff Spezialdiäten GmbH, Soest/Westfalen), ca. 100-120 g per animal and day, feeding once daily in the morning
- Water (e.g. ad libitum): tap water ad libitum from 7 am to 7 pm
- Acclimation period: min. 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): ca. 50%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12 / 12, from 6 am tp 6 pm, artificial light of ca. 27 Watt/m²

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: paraffin oil
Controls:
other: concurrent vehicle on the alternate flank of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): not explicitly noted; a paste was prepared of the test item
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6cm² of the flank
- Type of wrap if used: Hansamed band aid 'hypoallergen' (Beiersdorf No. 2342), fixed with elastic adhesive bandage (Fixomull-Stretch Klebevlies, Beiersdorf No. 2039), if experimentally required, an additional fixation with Leukoplast-porös (Beiersdorf No. 1524) was done

REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully with water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize-grading

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 1h - 7d
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 1h - 7d
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 1h - 7d
Irritant / corrosive response data:
Test item is not a skin irritant.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
The study was conducted under GLP according to OECD guideline 404 on the registered substance itself without deviations. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the skin irritating properties of 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl in rabbits. The substance did not provoke any reactions in the skin (erythema, edema, eschar), scoring according to Draize did not result in any score > 0 at any time point during the observation period. In consequence, the substance does not need to be regarded as skin irritant according to Regulation (EC) 1272/2008.
Executive summary:

In a primary dermal irritation study (OECD guideline 404), adult albino HC:NZW rabbits (3 males) were dermally exposed to 500 mg of 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl in paraffin oil for 4 hours to 6 cm². Animals then were observed for 14 days.  Irritation was scored by the method of Draize.

Scoring according to Draize did not result in any score > 0 at any time point during the observation period, the primary irritation index was determined to be 0.0.

In this study, 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl is not a dermal irritant.