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Toxicological information

Acute Toxicity: dermal

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acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2006-05-18 to 2006-06-01
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
GLP guideline study reliable without restrictions Minor deviations without an effect on the study: -According to the guideline, it is suggested to use rats between 200 and 300 g body weight. All the males had a body weight above 300 g (331 g - 341 g). - According to the guideline, the temperature of the experimental animal room should be 22 °C (+/- 3°C). In the study report it was stated that the temperature recorded in the animal room was sometimes outside of the target ranges specified in the Study plan. According to the report this deviation was not considerd to have compromised the validity or integrity of the study.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
, adopted 1987-02-24
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Cobalt(II) 4-oxopent-2-en-2-olate
EC Number:
EC Name:
Cobalt(II) 4-oxopent-2-en-2-olate
Cas Number:
Molecular formula:
cobalt(2+) bis(4-oxopent-2-en-2-olate)
Details on test material:
- Name of test material (as cited in study report): Peconal H- Physical state: Pink powder- Analytical purity: 98.9 % cobalt(2+) bis(4-oxopent-2-en-2-olate) dihydrate; (20.32 % total cobalt content)- Batch No.: 05022006- Expiration date of the batch: 2007-04-30- Storage condition of test material: At room temperature and under argon gasNo further information on the test material was stated.

Test animals

Details on test animals or test system and environmental conditions:
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: mean body weight +/- standard deviation of 334 +/- 4 g for males and 225 +/- 10 g for the females
- Housing: The animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm X 23.5 cm X 19.3 cm) Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet: All animals had free access to SsniffR/M-H pelleted diet (SSNIFF Spezialdiäten, GmbH, Soest, Germany
- Water (ad libitum): drinking water
- Acclimation period: At least 5 days (One to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm X 27 cm X 20 cm. Each cage contained autoclaved sawdust (SICSA, Alfortville, France.)

- Temperature: 22 +/- 2 °C
- Relative humidity: 30 to 70 %
- Ventilation: approx. 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 / 12
No further information on the test animals was stated.

Administration / exposure

Type of coverage:
Details on dermal exposure:
- Area of exposure: On the day before treatment the dorsal area of each animal was clipped (i.e approx. 5 cm X 7 cm for males and 5 cm X 6 cm for females) using am electric clipper. Only animals with helathy intact skin were used for the study. A single dose of 2000 mg/kg of the test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied to an area of the skin representing approx. 10 % of the total body surface of the animals, calculated accroding to Meeh's formula (i.e. approx. 5 cm X 7 cm for the males and 5 cm X 6 cm for the females). The test item and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

On removal of the dressing, any residual test item was removed using a dry cotton pad.

- Amount(s) applied: 2000 mg/kg (The dose applied to each animal was adjusted according to the body weight determined on the day of treatment.)
No further information on details on dermal exposure was stated.
No further information on details on dermal exposure was stated.
Duration of exposure:
24 hours
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: 15 days
- Frequency of observations and weighing:The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15. The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of CIT control animals with a similar initial body weight.
- Necropsy of survivors performed: Yes, on day 15, all animals were killed by carbon dioxide asphyxiation. All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.
- Other examinations performed: Type, time of onset and duration of clinical signs were recorded for each animal individually. From day 2, any local cutaneous reaction was recorded.
No further information on details on study design.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
When compared to CIT historical control animals, a slightly lower body weight gain was noted in 5/10 animals between day 1 and day 8, without any relevant consequence at the end of the observation period. The overall body weight gain of the other animals was not affected by treatment with the test item.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Other findings:
An erythema (4/10 animals) and a dryness of the skin (5/10 animals) were observed between day 5 and day 8. Crusts were observed in 4/10 animals between day 6 and day 14.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
Under the experimental conditions, the dermal LD50 of the test item Peconal H was higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regualtions and administrative provisions relating to the classification, packaging and labeling of dangerous substances, concerning the potential toxicity by dermal route, the test item Peconal H should not be classified.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified.