Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Identity FAT 65004/F TE
Batch 15060201 (China)
Purity determined in this study
Appearance
Smell
yellowish powder, solid at 20°C
neutral
pH-Value pH-value of a soln. of 2% (w/w) = 6.90
Expiration date August 25th, 2020
Storage to be stored at room-temperature
Specific details on test material used for the study:
Sample label: DCT-90162
Description: White liquid
Specific gravity: 0.98

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
New Zealand White rabbits, at least 8 weeks old when received, were equilibrated for at least one week in this laboratory. Two male and two female apparently healthy rabbits, were selected for the test.
The animals were housed 1/cage in suspended wire mesh cages (30" x 18" x 18"). Fresh Purina rabbit chow and water were freely available. The animal room, reserved exclusively for rabbits on acute tests, was maintained at 20 - 21°C and was kept clean in accordance with the standards of AAALAC.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Site Preparation -
24 hours prior to dosing, the fur was clipped from thebacks of the animals. The clipped area was 200 square cm, approximately 10 % of the body surface. Just prior to dosing, abrasions were made in one half of the rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding.

Observations -
Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system (attached). The rabbits were observed dail y for 14 days for signs of toxicity , pharmacological effects and mortality . Body weights were recorded pretest and i n the survivors at 7 and 14 days.

Termination -
At 14 days, the survivors were sacrificed . All animals were examined fo r gross pathology.

Duration of exposure:
24 hrs
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 male and 2 female
Control animals:
no
Details on study design:
Treatment -
Two male and two female rabbits were dosed at 2.0 g/kg. For liquid materials the dose was based on the sample weight as calculated from the specific gravity. The test material was applied once dermally to the prepared site under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material. The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. An estimate of the amount of material remaining was recorded. The exposure site was washed with warm tap water to remove excess material.
Statistics:
None

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
Clinical signs:
All animals were normal except for animal #4288-F which had diarrhea on Days 1 and 4 and lethargy an Days 1 and 2
Body weight:
No effect
Gross pathology:
All animals, sacrifice d on Day 14, were normal

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not toxic at a dose level of 2000 mg/kg of body weight.
Executive summary:

In a study conducted similar to OECD 434 guideline 2 male and 2 female New Zealand White rabbits were exposed to 2000 mg/kg of test substance FAT 65004.

Two male and two female rabbits were dosed at 2.0 g/kg. For liquid materials the dose was based on the sample weight as calculated from the specific gravity. The test material was applied once dermally to the prepared site under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material. The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. An estimate of the amount of material remaining was recorded. The exposure site was washed with warm tap water to remove excess material.

Observations -

Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system (attached). The rabbits were observed dail y for 14 days for signs of toxicity , pharmacological effects and mortality . Body weights were recorded pretest and i n the survivors at 7 and 14 days.

Termination -

At 14 days, the survivors were sacrificed . All animals were examined fo r gross pathology.

Results-

The 2 male and 2 females dosed at 2000 mg/kg survived in generally good health . There were no skin reactions, Body weights and necropsy findings were normal.

The test material is not toxic , at a dose level of 2000 mg/kg of body weight.