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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:
key study
Study period:
19 October - 12 November 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (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

1
Chemical structure
Reference substance name:
(carboxylatomethyl)hexadecyldimethylammonium
EC Number:
211-748-4
EC Name:
(carboxylatomethyl)hexadecyldimethylammonium
Cas Number:
693-33-4
Molecular formula:
C20H41NO2
IUPAC Name:
[hexadecyl(dimethyl)ammonio]acetate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch No.: UB 4051

Test animals

Species:
rat
Strain:
other: Crl: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles Rive Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg &, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Not specifically mentioned.
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 169-184 g
- Fasting period before study: 16 hours
- Housing: during the 14 day observation period the animals were kept in groups of 3 in MAKROLON cages (type III plus).
- Diet: commercial diet, ssniff R/M-H V1534 ad libitum. Discontinued 16 h before administration.
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 12-18
- Photoperiod (hrs dark / hrs light): 12/12 (approx 150 lux when lit)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not stated
- Amount of vehicle (if gavage): not stated
- Justification for choice of vehicle: Test item soluble in water


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw per administration

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg bw based on expected low toxicity of the test item.
Doses:
300 or 2000 mg/kg bw, given as two doages of 150 or 1000 mg/kg bw, respectively.
First administration at t = 0 h
Second administration at T = 3 h.
No. of animals per sex per dose:
6 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration, then daily during the 14-d period. Body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological changes.
Statistics:
Not applicable

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
300 mg/kg bw - no deaths
2000 mg/kg bw - 4/6 animals died
Body weight:
All surviving animals gained the expected wieght at the end of the study period.
Gross pathology:
No pathological changes observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the results of this study, the LD50 is >300 <2000 mg/kg bw.