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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
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
assessment report
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities throughout the whole study period.
Body weight:
Body weight development was not influenced throughout the study period.
Gross pathology:
Gross pathology revealed no macroscopically visible changes.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the test material showed no significant toxic effects. The established medium letal dose (LD50) was greater than 2000 mg/kg body weight.
Executive summary:

The study used as source investigated acute oral toxicity. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides
EC Number:
263-090-2
EC Name:
Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides
Cas Number:
61789-80-8
Molecular formula:
R2Me2N(+)Cl(-) whereas R = mainly C16, 18-alkyl molecular weight range is based on R=14 (lower limit value) and R=18 (higher limit value)
IUPAC Name:
N,N-Dimethyl-N,N-di-n-alkyl(C16-18)-ammoniumchloride
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Genamin DSAC (Dioctadecyldimethylammonium chloride)
- Physical state: solid
- Analytical purity: approximately 97 %
- Composition of test material, percentage of components: approximately 97% active, 3% water
- Isomers composition: n.a.
- Purity test date: no data
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: darkness, room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Strain: Hoe: WISKf(SPF71)
- Age at study initiation:
- male ca. 7 weeks
- female ca. 8weeks
- Weight at study initiation:
- male mean = 176 g; min = 167 g, max = 189 g; sd = +-8g
- female mean = 175 g; min = 171 g, max = 181 g; sd = +-4g
- Randomized
- Fasting period before study: 16 h before application and 3-4 hours after application of the test substance
- Housing: fully air-conditioned in makrolon cages (type 4) on soft wood chips in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 (Altromin-GmbH, Lage/Lippe) ad libitum
- Water (e.g. ad libitum): tap-water ad libitum
- Acclimation period: min 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 50 +- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

TEST ANIMALS
- Source: Hoe: WISKf (SPF71), Hoechst AG, Germany
- Age at study initiation: ca. 7 weeks (male animales); ca. 8 weeks (female animals)
- Weight at study initiation: 176g +/- 8g (male animals); 175g +/- 4g (female animals)
- Fasting period before study: ca. 16 hours prior and 4 hours after application
- Housing: Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE: sesame oil

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:
2000 mg/kg body weight (limit test)
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
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities throughout the whole study period.
Body weight:
Body weight development was not influenced throughout the study period.
Gross pathology:
Gross pathology revealed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the test material dioctadecyldimethylammonium chloride showed no significant toxic effects. The established medium letal dose (LD50) was greater than 2000 mg/kg body weight.
Executive summary:

The acute oral toxicity of Genamin DSAC was investigated in rats using sesam oil as vehicle. 5 male and 5 female rats were administered the test compound by single-dose gavage at a dose levels of 2000 mg/kg body weight (limit dose). After administration of 2000 mg/kg body weight no mortalities occurred. Unspecific clinical symptoms (bristled coat, squatting posture, stilted gait) were present up to 24 hours p.a. No clinical symptoms were observed from day 1 until the end of the observation period. Gross pathology revealed no macroscopically visible changes. Based on the findings of this test the median lethal dosage (LD50) of the test material Genamin DSAC (DHTDMAC) in the male and female rat is greater 2000 mg/kg body weight.

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