Cobalt, borate 2-ethylhexanoate complexes

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2006-04-25 to 2006-05-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

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 (308 g - 326 g).- According to the guideline, the temperature of the experimental animal room should be 22 °C (+/- 3°C) and the relative humidity 30 - 70 %. In the study report it was stated that the temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan According to the report, these deviations were not considerd to have compromised the validity or integrity of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987-02-24

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, cobalt salts

EC Number:

273-321-9

EC Name:

Resin acids and Rosin acids, cobalt salts

Cas Number:

68956-82-1

IUPAC Name:

Resin acids and Rosin acids, cobalt salts

Constituent 2

Reference substance name:

68956-82-1

Cas Number:

68956-82-1

IUPAC Name:

68956-82-1

Details on test material:

- Name of test material (as cited in study report): Produit Y- Name of test material (as cited in the EC inventory): Resin acids and Rosin acids, cobalt salts- Physical state: Purple powder- Analytical purity: 83.7 %; (7.77 % total cobalt content)- Batch No.: 06002 - Expiration date of the batch: 2007-04-30- Storage condition of test material: At room temperature, protected from light and humidity and under argon gas.No further information on the test material was stated.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- 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 315 +/- 7 g for males and 218 +/- 5 g for the females- Fasting period before study: - 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.)ENVIRONMENTAL CONDITIONS- 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 / 12No further information on the test animals was stated.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE- 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 an electric clipper. Only animals with healthy 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 corn oil) and then applied to an area of the skin representing approx. 10 % of the total body surface of the animals, calculated according 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.REMOVAL OF TEST SUBSTANCEOn removal of the dressing, any residual test item was removed using a cotton pad moistened by corn oil.TEST MATERIAL- 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.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males / 5 females

Control animals:

yes

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.

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occured during the study.

Clinical signs:

other: No clinical signs were observed during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Other findings:

A brown colouration of the skin was noted in all the animals from day 2 until day 12 (4/5 males and 4/5 females), 14 (1/5 females) or 15 (end of the observation period) (1/5 males). this colouration has masked the evaluation of the cutaneous reactions in 4/5 males and 4/5 females from day 2 until day 12.An oedema was noted in 1/5 males and 1/5 females from day 4 until day 7.An erythema was observed in 1/5 males from day 2 until day 7 and in 1/5 females from day 2 until day 14.Crusts were recorded in 1/5 females on days 13 and 14.A residual of test item was noted in all the animals from day 2 until day 15 (end of the observation period).

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Under the experimental conditions, the dermal LD50 of the test item Resin acids and Rosin acids, cobalt salts was higher than 2000 mg/kg in rats. According to the classification criteria laid down in Regulation (EC) No 1272/2008 (and subsequent adaptations) the test item Resin acids and Rosin acids, cobalt salts should not be classified.