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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study report reliable with restrictions. No original document, a translated German summary without signature and raw data, purity of test item is missing. The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004". In accordance with Section 1 (0.5), Annex I of Regulation (EC) No 1907/2006 (REACH), this study was considered reliable with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
, see "Rationale for reliability"
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Zincum N Stearat
Substances named zinc stearate or zinc distearate are considered equal to substance fatty acid, C16-18, zinc salts. Commercially produced stearic acid is always a mixture of what chemically was called stearic acid (C18) and palmitic acid (C16). In practice, the description “Fatty acids, C16-18, zinc salts” registered under CAS no 91051- 01-3 is a more exact fit with commercial zinc stearate (c.f. EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN, page 7).
No further information on the test material was stated.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: "Nossan" in Correzzana, Milan
- Age at study initiation: young healhty animals
- Weight at study initiation: mean weight 200 +/- 20 g
- Fasting period before study: Overnight fasting; 3 -4 hours after administration food supply is restored.
- Housing: Cages were made from translucent polycarbonate, Model 1290 (425 x 260 x 150 mm) from the firm Techniplast, Gazzada (Varese); The stable has an overpressure opposed to the atmosphere outside.
- Diet: Food pellets (Firm Nossan, Correzzana)
- Water (ad libitum): Filtered water from the municpal water supply; Filtered with Seitz-Filter
- Quarantine period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C +/- 2°C
- Humidity: 55 % +/- 10 %
- Air changes: minimal 8 times per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
The test substance is administered in its pure form or in a medium. If needed the test substance will be solved in either a suitable medium or in a suspension. Preferably in an aqueous medium, followed by a solution in vegetable oil, solution in other media and lastly a suspension. For nonaqueous mediua toxic characterisitcs should be considered.
The volume administered is either smaller or equal to 10 ml/kg body weight. Exceptionally up to 20 ml/kg body weight can be administered if a aqueous solution is used.
No further information on the oral exposure was stated.
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
Test group: 5 males / 5 females
Control animals: 5 males / 5 females (administered medium or physiological solution)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Careful clinical observations were made several times during the first day and afterwards once daily. For every animal the time of death will be noted. Signs of toxication are among others: weight variations, diarrhoea, general condition, every variation from the norm. Rats were weighed prior to administration and if they survived at the end of observation. The weight will be compared to the control animals.
- Necropsy of survivors performed: Yes
All rats that survive the observation period and all rats that died during the observation period will be subject to autopsy.
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:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No signs of intoxication was observed.
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the results of the study, zinc stearate has an LD50 (male and female rats) > 5000 mg/kg bw.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic via the oral route.
According to the Regulation (EC) No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

This conclusion is in accordance with the EU RAR.
Conclusions of EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004: "Zinc distearate does not need to be classified on the basis of its acute toxicity according to the EC criteria."