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Administrative data

Description of key information

Acute oral toxicity: Cetyldimethylbetaine LD50 (rat) is >300 <2000 mg/kg bw.

Acute inhalation toxicity: No study available.

Acute dermal toxicity: The substance is not expected to penetrate the skin in sufficient quantities to result in acute toxic effects.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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
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
Specific details on test material used for the study:
Batch No.: UB 4051
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)

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
Preliminary study:
Not applicable
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
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.
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:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The Source substance is the monconstituent C16 alkyldimethyl betaine. The Target is C12-16 (even numbered) -alkyldimethylbetaine, where 65-70% of the betaine content is the C16 chainlength and the remainder C12-14. Both substances will have similar properties and read across from the C16 to the C12-16 is possible.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: (carboxylatomethyl)hexadecyldimethylammonium [EC 211-748-4, CAS 693-33-4]
Target: betaines, C12-16 (even numbered) -alkyldimethyl [EC 947-036-1, CAS n/a]. Composition information per section 1.2

3. ANALOGUE APPROACH JUSTIFICATION
The Source substance, C16 betaine, makes up 65-70% of the betaine content in the Target substance, with C12 and C 14 betaines making up the remainder. Therefore the C16 betaine will make a proportionally greater contribution to acute toxicity compared to the C12-14 betaine. It should be noted that C12-14 betaine has not been classified for acute toxicity via the oral route according to information available on ECHA's dissemination website.

4. DATA MATRIX
Source: (carboxylatomethyl)hexadecyldimethylammonium [EC 211-748-4, CAS 693-33-4]: LD50 is >300 - <2000 mg/kg bw
Target: betaines, C12-16 (even numbered) -alkyldimethyl [EC 947-036-1, CAS n/a]: no data available.
Reason / purpose for cross-reference:
read-across source
Preliminary study:
Not applicable
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Acute oral toxicity: Cetyldimethylbetaine LD50 (rat) is >300 <2000 mg/kg bw. Acute category 4 under CLP.

No data available for inhalation or dermal routes.