Betaines, C12-16 (even numbered) -alkyldimethyl

Endpoint summary

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

Reference

Reference 1

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.

Reference 2

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

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.