Reaction mass of sodium hydrogen N,N-dibutyl-10-(sulphonatooxy)octadecanamidate and sodium sulphooctadecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974-05-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

female animals only, 10 animals per group

GLP compliance:

no

Remarks:

predates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dibutyloleamide and oleic acid, sulphated, sodium salts

EC Number:

915-926-9

Molecular formula:

C18H34Na2O6S + C26H52NNaO5S

IUPAC Name:

N,N-dibutyloleamide and oleic acid, sulphated, sodium salts

Test material form:

liquid

Details on test material:

The water content of the actual test item was 57.6% (w/w); the water content of the REACH registration substance was analytically determined to be 3.8% (w/w).

Specific details on test material used for the study:

- Name of test material (as cited in study report): Humectol CX spezial
- Substance type: fatty acid derivative
- Physical state: liquid
- Analytical purity: no details
- Impurities (identity and concentrations): no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

25 % solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %

Doses:

2500, 4000, 6300, 10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation daily and weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 4 609 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 808 - <= 5 578

Remarks on result:

other: Probit analysis nach Linder & Weber; Vertrauensgrenzen nach Cavalli-Sforza

Mortality:

Animals died 2 hours to 2 days after treatment
Dose Mortality
2500 0/10
4000 5/10
6300 7/10
10000 10/10

Clinical signs:

other: Animals showed piloerection, red secretion from the nose and reduced general behaviour before death. Shortly before death tonic seizures were observed.

Gross pathology:

At necropsy reddish secretion was detected in the gut of deceased animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not classified due to an LD 50 value of > 2000 mg/kg body weight (4609 mg/kg bw).

Executive summary:

Humectol CX special, which had the appearance of a red-brown oily liquid, was administered once as a 25 % solution in water in various doses by means of a stomach tube to female SPF Wistar rats. The test was carried out in female rats because no sex-related differences were observed in preliminary tests. For every dose, 10 rats were used. The animals’ feed was withdrawn 16 hours before application, and resumed 2 hours after application of the solution. Observation time after the application lasted 14 days. During this time, in which the animals were weighed once a week, the animals received as feed a diet of ALTROMIN 1324 from the firm of Altrogge in Lage/Lippe, Germany and mains water. Feed and water were made available at will. The animals were kept in plastic cages on wood shavings. The LD50 as determined by means of a probit analysis (method according to LINDER and WEBER) was 4609 mg test item/kg bw. The lethally poisoned animals showed bristled skin, bloody secretion from the nose and lethargic behavior. Death occurred with tetanic cramps.