Fatty acids, C8-16, tetraesters with pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

August 30th, 1983 - September 13th, 1983

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Insufficient for assessment due to reduced animal number. Only 2 male and 2 female animals were used, details on test substance not documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: Only two male and two female animals used, details on test substance not documented

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, esters with pentaerythritol

EC Number:

285-547-5

EC Name:

Fatty acids, C16-18, esters with pentaerythritol

Cas Number:

85116-93-4

IUPAC Name:

85116-93-4

Details on test material:

- Physical state: white, solid powder
- Analytical purity: >99%
- Composition of test material, percentage of components: free fatty acids <0.5%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: >6 weeks
- Weight at study initiation: males: 282.5 g; females: 166.0 g
- Fasting period before study: 15 h
- Housing: Makrolon Type III cages
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: > 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 1.62 ml - 2.95 ml depending on body weight


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Frequency of observations and weighing: evaluation of mortality: twice daily; weighting on days 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Duration of observation period following administration: 14 d
- Other examinations performed: body weight, macroscopic abnormalities (post mortem)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: No significant signs of toxicity except for transient rough fur and reduced activity direct after dosing

Gross pathology:

No macroscopic findings

Any other information on results incl. tables

The limit dose of 2000 mg/kg showed no mortality in male and female rats. Although only 2 animals per sex were tested, the observations do not indicate a toxic effect.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information The acute oral lethal dose was greater than 2000 mg/kg in male and female rats. Criteria used for interpretation of results: EU