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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Silver docosanoate
EC Number:
219-641-4
EC Name:
Silver docosanoate
Cas Number:
2489-05-6
Molecular formula:
C22H44O2.Ag
IUPAC Name:
silver(1+) docosanoate
Constituent 2
Reference substance name:
CH03220
IUPAC Name:
CH03220
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): CH03220
- Molecular formula (if other than submission substance): C22H4402.Ag
- Molecular weight (if other than submission substance):447.44
- Physical state: white powder
- Analytical purity: 100 wt % silver docosanoate
- Lot/batch No.: CH03220/AJ
- Storage condition of test material: at room temperature, protected from light
- Stability under storage conditions: stable
- Expiry date: 25 nov 2012 (1 year after receipt of the test substance)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
- Species: Rat, Wistar strain Crl:WI (Han) (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC)
- Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
- Age and body weight: Young adult animals (approx. 8-9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
- A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
single dose: 2000mg/kg (10ml/kg)
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
dissolved
Remarks on result:
other: No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Mortality:
No mortality occurred.
Clinical signs:
Hunched posture and/or piloerection were noted in all animals on Day 1.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
One animal showed pelvic dilation. No further abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of CH03220 in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Based on these results, CH03220 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
Executive summary:

Assessment of acute oral toxicity with CH03220 in the rat (Acute Toxic Class Method).

The study was carried out based on the guidelines described in:
OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"
Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method" EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"
JMAFF guidelines (2000) including the most recent partial revisions.

CH03220 was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred.
Hunched posture and/or piloerection were noted in all animals on Day 1.

The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

One animal showed pelvic dilation. No further abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of CH03220 in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, CH03220 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the:

  • -  Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United

    Nations (2011),

  • -  Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and

    mixtures