C12-16-(even numbered)-alkyl-dimethylammonium lactate

Acute Toxicity: oral

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:

From 8.2.1988 to 30.3.1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

There are no deviations from the recommended guideline. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance. It is hypothesized that the toxicity of the target chemical can be derived from the respective toxicity data of DMAs with comparable length of alkyl chain (source substances). The underlying scientific rationale is based on the physico-chemical property of the target chemical and “chain length category”.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyldimethylamine

EC Number:

203-943-8

EC Name:

Dodecyldimethylamine

Cas Number:

112-18-5

IUPAC Name:

N,N-dimethyldodecan-1-amine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Male: 194g Female: 173g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/-20
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Male: 1250 / 1600 and 2000 mg/kg
Female: 1250 / 1600 and 1800 mg/kg

No. of animals per sex per dose:

7 Females and 8 Males

Control animals:

no

Statistics:

probit analysis

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 890 mg/kg bw

Based on:

test mat.

95% CL:

1 750 - 2 560

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 450 mg/kg bw

Based on:

test mat.

95% CL:

1 110 - 1 720

Mortality:

Mortality was observed by day 1 or 2 after gavage.

Clinical signs:

other: Animals showed besides from unspecific poisoning symptoms an influenced movement of body and breathing, bloody crusted eye lids and mouths, narrowed eye lid splits and diarrhoea.

Gross pathology:

Symptoms were reversible in male after 5 and female animals after 9 days after gavage.

Any other information on results incl. tables

Dosis in mg/kg Kgw.	Concentration in % (w/v)	Appication Volume in ml/kg Kgw.	Nº Male	Nº Female
1250	12.5	10	5	5
1600	16.0	10	5	5
1800	18.0	10	-	5
2000	20.0	10	5	-

Dosis mg/kg Kgw.		Lethality
	Male absolute	Male relativ (%)	Female absolut	Female relativ (%)
1250	0/5	0	1/5	20
1600	1/5	20	3/5	60
1800	-	-	5/5	100
2000	3/5	60	-	-

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity of the target substance was assessed based on the analogue appraoch using N,N-dimethyldodecan-1-amine as read-across supporting substance. Under the conditions of this study the LD50 of N,N-dimethyldodecan-1-amine was 1450 mg/kg for female rats and 1890 mg/kg for male rats

Executive summary:

The acute oral toxicity of the target substance was assessed based on the analogue appraoch using N,N-dimethyldodecan-1-amine as read-across supporting substance.

The testing of acute toxicity of the substance in the Wistar rat gave the following dosage LD50:

Female animals: 1450 mg/kg body weight; Male animals: 1890 mg/kg body weight

Mortality was observed within 2 days after gavage.

Animals showed besides from unspecific poisoning symptoms an influenced movement of body and breathing, bloody crusted eye lids and mouths, narrowed eye lid splits and diarrhoea. Symptoms were reversible in male after 5 and female animals after 9 days after gavage.

The development of body weight was in the first testing week in one female animal with 1250 mg/kg-gavage lower than in controls. At the final stage of testing the animal exceeded the initial body weight, which was measured before starting testing. In the other animals body weight development was normal.

The section of animals showed dark coloured liver, reddened mucous membrane of stomach and punctual bleedings in the stomach. After finalising the testing the animals did not show macroscopic visible abnormalities.