Registration Dossier

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 was considered not related to treatment and of no toxicological significance.
Body weight:
Changes reported in body weight gain in males and females were within the range expected for rats used in this type of study and were not considered indicative of toxicity.
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.