Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 625-Triketone
- Substance No.: 95/225-1
- Physical state: Powder, beige
- Analytical purity: 99.2 %
- Lot/batch No.: LJ 27881/1
- Date of manufacturing: 18-27 Jul 1995
- Stability under test conditions: guaranteed by the sponsor and verified by reanalysis
- Storage condition of test material: refrigerator

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Strain/Quality: WISTAR / CHBB: THOM (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight; (200 g – 300 g) (± 20% of the mean weight)
- Fasting period before study: 16 hours
- Housing: single housing
- Diet: KLIBA-Labordiaet 343, Klingenthalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Analysis of drinking water
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of the BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in the study was assayed for chemical and microbial contaminates.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped epidermis of the dorsal and dorsolateral parts of the trunk
- Application area: about 50 cm²


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration: 50 g/100 ml
- Constant volume or concentration used: yes

Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice each workday and once on Saturdays, Sundays and on public holidays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

SCORING OF SKIN FINDINGS:
Individual readings: 30 - 60 minutes after removal of the semiocclusive dressing (day 1), weekly thereafter and at the end of the study period.

ASSESSMENT OF SKIN FINDINGS:
According to Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs, and cosmetics. The Association of food and drugs officials of the United States, Austin Texas

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred.
Clinical signs:
systemic effects
no systemic signs of toxicity noted

local effects:
very slight to well-defined erythema and very slight to slight edema
Body weight:
The expected body weight gain has been observed.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion