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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 August to 3 November 1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol
EC Number:
601-595-5
Cas Number:
119302-20-4
Molecular formula:
C27H46N2O3
IUPAC Name:
(3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): Pymordiol
- Physical state: Cream white solid
- Purity of test material: 96% wt%
- Expiration date of the lot/batch: 1 January 2001
- Stability under test conditions: Stable throughout test period.
- Storage condition of test material: At room temperature in the dark.

Test animals

Species:
rat
Strain:
other: Wistar Crl:(WI) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approx. 9 weeks old
- Weight at study initiation: Did not exceed +/- 20% of sex mean.
- Housing: Individually housed in polycarbonated cages containing purified saw dust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnout, Belgium).
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21˚C
- Humidity (%): 50%
- Air changes (per hr): Approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light/12 hours dark

IN-LIFE DATES: From: 12 August 1999 To: 26 August 1999

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: Back of animals
- % coverage: 10%
- Type of wrap if used: Surgical gauze patch, successively covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape was additionally used for fixation of the bandages to females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg body weight
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 Males and 5 Females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Observations - twice daily, body weights - days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: Yes, Sacrificed by asphyxiation using an oxygen/carbon dioxide procedure.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Clinical signs - On day 1 of dosing and once daily thereafter, until day 15.
Statistics:
Not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
other: Scabs and scales were seen in the treated skin-area of one female between days 2 and 8. Red staining of the fur in the neck appeared in another female on day 9 and persisted until termination. Based on the incidence and time of occurrence, this finding
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under current test conditions the LD50 value for test substance exceeds 2000 mg/kg body weight.