acetalization product between glucose and C16-18(even numbered)- alcohol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-12-28 to 1990-01-11

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Substance type: UVCB
- Physical state: solid
- Composition of test material, percentage of components: cettearyl alcohol 80% and cetearyl glucoside 20%
- Storage condition of test material: in hermetically stoppered glass flask and stored at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

rats 12 months old at the beginning of the study.
5 males: 182.2+/- 4.4 g
5 females: 177. 4 +/-5.4g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10ml/kg
- Justification for choice of vehicle:the product is a cristallin salt so the water is sufficient as vehicule



MAXIMUM DOSE VOLUME APPLIED: 2g/kg

Doses:

2g/kg

No. of animals per sex per dose:

5 females and 5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:during the 3 hours following the administration, tha animals were quasi continiously observed. during the following 14 days, a daily observation was made.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LDLo

Effect level:

> 2 000 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

other: NOEL acute oral systemic

Effect level:

ca. 2 000 mg/kg bw

Effect levels 4

Sex:

male/female

Dose descriptor:

other: NOEC acute oral local

Effect level:

ca. 2 000 mg/kg bw

Mortality:

no deaths were recorded

Clinical signs:

no sign evidencing any toxicity at the level of the central nervous system or neuro vegetative system was noted

Body weight:

the weight increase of male and femalae animals was normal comparable to that of animals from this strain

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions employed, the chemical failed to lead any mortality.
The autopsy of the animals at the end of the trial failed to evidence any necroscopic lesions that could be related to toxic effect of the product.
The minimal lethal dose of the product is therefore greater than 2 g/kg in the Sprague Dawley rat, when administered in a single oral dose.

Executive summary:

The substance was given in a single oral administration, at the dose of 2g/kg, to 5 male rats and 5 female rats, according to the protocol recommended by the guidelines OECD (n° 401 dated 24.02.1987).

From the results of this trial , it can be conclude that, under the experimental conditions employed, the minimal lethal dose of the substance is above 2g/kg.