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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:
June to July 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
17 July 1992
Deviations:
yes
Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
Principles of method if other than guideline:
A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy
IUPAC Name:
Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy
Constituent 2
Chemical structure
Reference substance name:
13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one
EC Number:
219-034-4
EC Name:
13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one
Cas Number:
2322-77-2
Molecular formula:
C20 H28 O2
IUPAC Name:
3-Methoxy-18-methyl-2,5(10)-estradien-17-on
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
other: Han: WST (SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: 106-118 g (males) and 95-111 g (females)
- Fasting period before study: ca. 19 hours
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 54-64%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 900 mg NaCl ad 100 ml bidist. water
Controls:
other: the untreated skin served as control
Amount / concentration applied:
212-236 mg/male animal or 190-222 mg/female animal
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females
Details on study design:
OBSERVATION TIME POINTS
Body weight and other observations were performed at day 1, 7 and 14.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

All animals without any local irritations (no further data available).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg (212-236 mg/male and 190-222 mg/female applied as a paste) was tolerated without any local irritations.
Executive summary:

In a primary dermal irritation study similar to OECD TG 404, (young adult) Wistar rats, female and male (3/sex) were dermally exposed to 212-236 mg/male animal or 190-222 mg/female animal of D-ET-Dienon in physiological saline for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method according to the system recommended in Directive 67/548/EEC.


 


No local irritations were observed. In this study, the test item is not a dermal irritant.