Glycerides, palm-oil mono-, hydrogenated, acetates

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:

11 Jan - 12 Mar 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According 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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 mono- and di-

EC Number:

286-490-9

EC Name:

Glycerides, C16-18 mono- and di-

Cas Number:

85251-77-0

IUPAC Name:

85251-77-0

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01

Test animals

Species:

rat

Strain:

other: Rat Ico: OFA.SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO, L'Arbreles, France
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 163-172 g (males) and 138-149 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed in groups of 5 per sex in polycarbonate cages type MI (365 x 225 x 180 mm) with dust-free sawdust bedding from spruce tree wood.
- Diet: pelleted complete diet, diet reference A04 C10 (Usine d'Alimentation Rationnelle, Epinay/Orge, France), ad libitum
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% (w/w)
- Lot/batch no.: A28557/1
- Purity: pure
Test substance preparation was administered within 4 hours of preparation.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed for clinical signs 15 min, 1 h, 2 h and 4 h after administration of the test subsatnce and daily during the 14-day observation period. Individual body weights were determined on Day -1, immediately before administration on Day 0, and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

In a preliminary study, 2.5, 5 and 10% of the test substance in vehicle (corresponding to 500, 1000 and 2000 mg/kg bw) were administered to 2 males and 2 females per test group. No mortality was observed at any of the concentrations tested. Thus, a dose of 2000 mg/kg bw (10% test concentration) was chosen for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality way observed during the study period.

Clinical signs:

other: There were no abnormal clinical signs in any of the treated animals during the observation period.

Gross pathology:

There were no macroscopic findings at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified