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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:
All animals at all levels exhibited decreased motor activity, coordination disturbance, abnormal body posture, abnormal gait, diarrhea and piloerection beginning approx. 20 min after dosage. At the two highest dose levels animals showed decreased grip- and limbtone. These symptoms partly persisted for 24h. At the 48h observation and later, all surviving animals appeared normal.
Body weight:
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:
not classified
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 both CLP and DSD.