Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study with well characterized test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Organic
- Physical state: Solid
- Lot/batch No.: Z-2281/1,2,4,5
- Expiration date of the lot/batch: April 01, 1997
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: males: 235 to 287 g, females: 181 to 213 g
- Fasting period before study: overnight
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1993-01-14 To: 1993-01-28

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: on the back of the animal
- coverage: 25 cm2 (5x5 cm) for males and 18 cm2 (3.5x5 cm) for females
- Amount(s) applied (volume or weight with unit): 10 ml/kg body weight
- Type of wrap if used: application on a gauze patch fixed successively to aluminium foil and flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance was removed with tissue moistened with tap-water
- Time after start of exposure: 24h

TEST MATERIAL

- Concentration (if solution): 10 ml/kg body weight
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily (mortality, viability), once daily (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (daily)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
No clinical signs of ill health or behavioural changes were observed during the study period.
Body weight:
Low or no body weight gain or loss of body weight was noted in 7 animals over
the first week and in 1 animal over the second week. The remaining 3 and 9
animals showed normal body weight gain over these two study periods.
Gross pathology:
Macroscopic post mortem examination of the aniraals at termination did not reveal any abnormalities.
Other findings:
The treated skin area of all animals was discoloured red by the test substance during the study period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU