Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1994-12-01 to 1994-12-15
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Comparable to guideline reliable with restrictions Minor deviations without an effect on the results: - The stability of the test item was missing. - The raw data of body weight, pathological findings and clinical signs (two females) were missing in the study report. Narrative descriptions were given for body weight, pathological findings and clinical signs.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
, 1987-02-24
, see "Rationale for reliability"
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Potassium thiosulphate
EC Number:
EC Name:
Potassium thiosulphate
Cas Number:
dipotassium thiosulfate
Constituent 2
Reference substance name:
potassium thiosulfate
potassium thiosulfate
Details on test material:
- Name of test material (as cited in study report): Potassium thiosulfate
- Physical state: Clear light yellow liquid
- Active ingredient: 49.33 % K2S2O3:
- Lot No.: 11-074-PHX
- Storage condition of test material: Room temperature
- Density: 1.47 g/ml
No further information on the test material was stated.

Test animals

New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Myrtle's Rabbitry, Thompson Station, TN
- Housing: The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommedned by the Guide for the Care and Use of Laboratory Animals (Guide for the Care and Use of Laboratory Animals, DHHS Publication No. (NIH) 86 - 23, 1985.)
- Diet (ad libitum): Purina Certified Rabbit Chow #5322
- Water (ad libitum): Municipal tap water treated by reverse ososis
- Quarantine period: A minimum of five days (Animals were examined on arrival. All animals received a detailed pretest observation prior to dosing. only healthy animals were chosen for study use.)

- Temperature: 20 - 22.2 °C
- Relative humidity: 30 - 67%
- Air changes: Ten to twelve air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
- Area of exposure: On Day-1, the fur was removed from the dorsal trunk area of the animals chosen for the limit test using an animal clipper. The clipped area was ≥ 10% of the animal's body surface area (BSA). Care was taken to avoid abrading the skin during the clipping procedure. On the following day (day 0), the test article was administered dermally to approximatley 10 % of the body surface area (BSA). The BSA was calculated for each animal using the formula [BSA in cm^2 = 9 X (body weight in grams)^0.66667] and the four corners of this area were delineated in the clipped area with an indelible marker. The test article was spread evenly over the delineated test area.
- Type of wrap if used: The test substance was held in contact with the skin with an appropriately sized 4 ply porous gauze dressing backed with plastic wrap (occlusive binding). Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and test area. The elastic wrap was further secured with adhesive tape around the trunk at the cranial and caudal ends. After dosing, collars were placed on the animals and remained in place until removal on study day 3.

- Washing (if done): After approximately 24-hour exposure period, the gauze dressing, plastic and elastic wrap were removed and the corners of the test site delineated using a marker. Residual test article was removed using gauze moistened with distilled water.

The test article was administered as received from the Sponsor.
- Amount(s) applied (volume or weight with unit): Individual doses were calculated based on the animal's day 0 body weight.
- Concentration: 100 %
- Constant volume or concentration used: Yes
No further information on the dermal exposure was stated.
Duration of exposure:
Approximately 24 hour
2000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Limit test animals were observed for clinical abnormalities two times on study day 0 (postdose) and daily thereafter (days 1-14). A mortality check was performed twice daily, in the morning and afternoon.Limit test animals were examined for erythema and oedema following patch removal on study day 1 and daily thereafter (days 2-14) according to te Dermal Grading System based on Draize (Draize, J.H., Appraisal of the Safety of Chemcicals in Foods, Drugs and Cosmetics, The Association of Food and Drug Officials of the United States, 49-51, 1959.). The dermal test sites were reclipped as necessary to allow clear visualization of the skin. Individual body weights were obtained for the limit test animals prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: Yes, all limit test animals were euthanized (intravenous injetion of sodium pentobarbital) at study termination (day 14) and necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained.
No further information on the studdy design was stated.
Data from the limit test were analyzed and an LD50 value estimated as follows:
< 50 % Mortality: LD50 was estimated as greater than the administered dose
= 50 % Mortality: LD50 was estimated as equal to the administered dose
> 50 % Mortality: LD50 was estimated as less than the administered dose.
Body weight means and standard deviatio n were calculated separately for males and females for each limit level administered.

Results and discussion

Effect levelsopen allclose all
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The LD50 was estimated.
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The LD50 was estimated.
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The LD50 was estimated.
No mortality occurred during the limit test.
Clinical signs:
The most notable clinical abnormalities observed during the study included transient incidences of fecal stain. Dermal irritation was noted at the sites of test article application.
Body weight:
Body weight gain was noted for all animals during the test period.
Gross pathology:
No significant gross internal findings were observed at necropsy on study day 14. Two incidences of cyst(s) on the oviduct(s) were observed; however, these findings were not considered significant since they are commonly found in rabbits of this strain.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
Under the conditions of this test, the acute dermal LD50 of potassium thiosulfate was estimated to be greater than 2000 mg/kg in the rabbit.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic by the dermal route.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic by the dermal route.