Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study with acceptable restrictions Minor devaitions from the guideline with no effect on the study results: - The purity and stability of the test substance is missing. - According to the guideline, weights of the animals during the observatin period should be determined, which is missing in this report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
, see "rationale for reliabiility"
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
, see "rationale for reliabiility"
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
7719-01-9
Cas Number:
7719-01-9
IUPAC Name:
7719-01-9
Constituent 2
Reference substance name:
Calcium dihydroxide
EC Number:
215-137-3
EC Name:
Calcium dihydroxide
Cas Number:
1305-62-0
IUPAC Name:
calcium dihydroxide
Details on test material:
- Name of test material (as cited in study report): "Weisskalkteig" (from the Federal German Lime Industry Association in Cologne), which is generally known as a paste-like mixture of Calcium dihydroxide with water (white lime paste).
No further information on the test substance was stated.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Germany, External branch
- Weight at study initiation: 2.4 to 2.9 kg
- Housing: Individual cages
- Diet (ad libitum): Commercially available complete feed
- Water (ad libitum)
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 2 °C
No further information on the test animals was given.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
The test item "Weisskalkteig" is most appropriately translated as "white lime paste". As such it is an aqeous paste-like preparation and does not require further moistening in order to ensure good skin contact.
Details on dermal exposure:
TEST SITE
- Area of exposure: On the day before the test sample was applied to the rabbits, the fur on their skin was sheared over an area of some 8 cm wide and 15 cm long. The test sample was applied evenly with a plastic spatula on an area of 100 cm^2 of shorn skin.
- Type of wrap if used: The treated skin area was covered with a gauze. The gauze was affixed using a "Peha-haft" dressing, so that the animal could not strip off the gauze.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin area was rinsed with water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quantity of 2.5 g/kg of body weight
No further infomration on dermal exposure was stated.
Duration of exposure:
24 hours
Doses:
2500 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (including treatment day)
- Frequency of observations and weighing: The animals were clinically examined on a daily basis.
- Necropsy of survivors performed: Yes
On the last day of the observation phase, the rabbits were put down byintravenous injection of Pentobarbital (Nembutal R), and then immediately dissected in the Institute of Pathology, of the Hannover College of Veterinary Medicine.
- Other examinations performed: During the daily clinical observations, the general conditions were observed plus changes that occurred in the area of the fur and the treated skin, the eyes and the mucous membranes were registered and recorded.
No further information on the study design was stated.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
There were no indications of toxic effects from the test sample after dermal application.
Clinical signs:
other: Overall, redness, followed by scabbing, did occur in the area of the treated skin after the dressing was removed and the skin was cleaned. Slight redness after removal of the dressing was observed in one female rabbit. Moderate redness plus scabbing was o
Gross pathology:
Dissection of the rabbits yielded no particular results.
Other findings:
- Histopathology: The pathological-histological examination of the liver, kidneys, lung and skin yielded no particular results.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The available data showed that the tested White lime paste caused no acute toxic effect after dermal application. However, thest did show skin irritating effects from the test sample.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified.

Categories Display