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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well-documented non-GLP study performed according to a method similar to OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in foods, drugs and cosmetics; by the Staff of the Division of Pharmacology, FDA, 1959
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide
EC Number:
939-581-9
Cas Number:
1471314-81-4
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aminoxid WS 35
- Substance type: light-yellow, clear watery liquid
- Physical state: liquid
- Other: pH 5.0

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 160-205 g
- Fasting period before study: 16h prior to dosage
- Housing: in groups of 5 rats in plastic cages (42x26x14 cm) on wood chips bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Substance was administered in a 100% concentration at dosage levels of 3.98, 5.00, 6.30 and 7.94 ml/kg bw.
Doses:
3.98, 5.00, 6.30 and 7.94 ml/kg.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosage, and at least once daily thereafter.
- Necropsy of survivors performed: yes
Statistics:
Mortality data by Probit-analysis

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6.24 mL/kg bw
Based on:
test mat.
95% CL:
> 5.84 - < 6.65
Mortality:
After 14 days: 0/10 died at 3.98 ml/kg; 2/10 animals died at 5 ml/kg; 6/10 died at 6.30 ml/kg; 8/10 died at 7.94 ml/kg.
Clinical signs:
other:
Body weight:
other body weight observations
Remarks:
No effects.
Gross pathology:
Animals that died during the study showed slight redness of the gastro-intestinal mucous membrane and the intestine was filled with liquid.
Surviving animals did not show adverse effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral rat LD50 derived after acute exposure and a 14-day recovery period, was 6.24 ml/kg bw. Assuming a relative density of 1, the oral LD50 equals 6240 mg/kg bw. When correcting for the active content (i.e. 35%) the LD50 is 2184 mg/kg bw , which is above the classification limits of the CLP Regulation.