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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: males: 12 weeks; females: 12 weeks
- Weight at study initiation: males: 297 - 337 g; females: 224 - 260 g
- Housing: Individually 1n Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz/Switzerland).
- Diet: Pelleted standard Kliba 343, Batch 31/88 and 34/88 rat maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst/Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: At least one week under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22+/-3 °C
- Humidity: 40-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent Iight/12 hours dark, music/light period.

Administration / exposure

Type of coverage:
occlusive
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 the test article was applied evenly on the skin with a syringe and covered with an 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, dried with disposable paper towels and the skin reaction was assessed according to the method of Noakes and Sanderson (Br J Ind Med; 1969; 26:59-64).

Application volume/kg body weight: 4 ml at 2000 mg/kg

Rationale:
The dermal administration was used because this is one possible route of human exposure during manufacture, handling and use of the test article.

Duration of exposure:
24 hours
Doses:
Application volume/kg body weight: 4 ml at 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: Four times during test day 1, and daily during days 2 - 15.
- Frequency of weighing: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
LOGIT model could not be applied.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen throughout the observation period.
Clinical signs:
The following local findings were observed: erythema (females), blue discolored application area.
The female rats had recovered from erythema within 12 observation days, whereas blue discolored application area was observed until termination of test in animals of both sexes.
Body weight:
no adverse effect was seen.
Gross pathology:
No macroscopic organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 of FAT 40336/B was estimated to be >2000 mg/kg bw.
Executive summary:

FAT 40336/B was assessed for toxicological potential when administered to rats by a single occlusive dermal application, with an observation period of 15 days. The test article FAT 40336/B was applied to the shaved skin of rats of both sexes for 24 hours at a dose of 2000 mg/kg bw. No mortality was observed. Therefore, the dermal LD50 of FAT 40336/B was estimated to be >2000 mg/kg bw.