1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C16-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Study was conducted on the test material and followed OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide

EC Number:

246-584-2

EC Name:

(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide

Cas Number:

25054-76-6

Molecular formula:

C25H48N2O3

IUPAC Name:

N-(carboxymethyl)-N,N-dimethyl-3-(oleoylamino)propan-1-aminium hydroxide

2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Dihydrogen oxide

3

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

propylene glycol

4

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

sodium chloride

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

All animals will be housed individually hourse in stainless steel cages and will be offered food and water ad libitum

Administration / exposure

Type of coverage:

occlusive

Details on dermal exposure:

Twenty-four hours prior to application of the test material, the trunk of the rabbit is shaved. The 24-hour period between shaving and application of the test material allows recovery of the stratum corneum from hte disturbance caused by shaving. All animals are weighed on day of dosing. Based upon the animal's body weight, the test material is applied and a sleeve of plastic sheeting is fitted oven the shaven trunk of the animals and secured in place with adhesive tape. The test material remains in contact with the skin for a 24 hour period after which time the wrap is removed and any remaining test article wiped off

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortalities were recorded during the duration of the study

Clinical signs:

other: No clinical signs of toxicity were reported

Gross pathology:

No gross chnages observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 is greater than 2000 mg/kg

Executive summary:

No mortalities or clinical signs of toxicity were observed during the duration of the study. The LD50 is > 2000 mg/kg and does not meet the criteria for classification under GHS