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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): FAT 40'400/A
- Lot/batch No.: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995
- Stability: Stable
- Stability of test article dilution: at least 2 hours

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 9 weeks, females, 11 weeks
- Weight at study initiation: males: 218 - 243 g, females: 194 - 206 g
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batches 67/90 and 68/90 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst, available ad libitum
- Water (e.g. ad libitum): Community water from Itingen, available ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface. On test day 1, 4 mL at 2000 mg/kg test article was applied evenly on the skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water and dried with disposable paper towels and the skin reaction was assessed.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Mortality/viability were measured four times during test day 1 (pre-administration) and daily during days 2 - 15.
- Body weights were measured on day 1, 8 and 15.
- All animals were necropsied.
- Each animal had an examination for changes in appearance and behaviour four times during day 1, and daily during days 2-15. All abnormalities were recorded.
Statistics:
The LOGIT-Model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occured
Clinical signs:
- skin/fur: scales (back), skin yellow (back). Scales and discoloration were observed until termination of the study.
- No systemic symptoms were observed in the animals during the study.
Body weight:
The body weight gain of the animals was not affected by the test article treatment throughout the entire study.
Gross pathology:
No macroscopic organ findings were observed in the animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The toxicity of the test substance was estimated to be >2000 mg/kg bw.
Executive summary:

In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were administered the test substance (2000 mg/kg bw). The test substance was dissolved in water and applied on the skin with a syringe and covered with a semi-occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Scales and discoloration were observed until termination of the study. No macroscopic findings were noted. Therefore, the toxicity of the test substance was estimated to be >2000 mg/kg bw.