Reaction mass of (Z)-3-(9-octadecenyloxy)propane-1,2-diol and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-di[oxy[(hydroxymethyl)-1,2-ethanediyl]] and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-tri[oxy[(hydroxymethyl)-1,2-ethanediyl]]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10-24 July 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study following OECD guideline 401 with minor deviations: environmental conditions not reported

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

environmental conditions not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

COFRAC accredidation on technical ability

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

9022-76-8

Details on test material:

- Name of test material (as cited in study report): CHIMEXANE NB - Batch M 824
- Physical state: Yellow viscous liquid
- Analytical purity: 98 %
- Lot/batch No.: M 824
- Date of receipt: 02 July 1997
- Storage condition of test material: At room temperature, away from the light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO (L'Arbresle, France)
- Age at study initiation: About 6 weeks
- Weight at study initiation: Male: 184-209 g; female: 174-187 g
- Fasting period before study: Overnight
- Housing: Housed in groups of five by sex in polypropylene cages
- Diet (e.g. ad libitum): Complete pelleted rat maintenance diet UAR A04-10 (Epinay Sur Orge, France)
- Acclimation period: At least 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: Animals were observed frequently during the 5 h following administration of the test item; subsequently once daily up to 14 days.
Body weight was recorded on Days 1 (just before administration), 4, 8 and 15.
- Necropsy of survivors performed: Yes, all surviving animals were sacrificed by barbituric anaesthesia on Day 15 and then autopsied.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No clinical signs were observed.

Body weight:

All animals showed expected gain in bodyweight over the study period.

Gross pathology:

No macroscopic abnormalities were observed at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for CHIMEXANE NB - Batch M 824 is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an acute oral toxicity (limit test) study performed in accordance with OECD guideline 401, groups (5/sex) of Sprague-Dawley OFA rats were given a single oral dose of CHIMEXANE NB - Batch M 824 in distilled water at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all macroscopically necropsied after sacrifice.

 

No deaths were observed and animals appeared normal throughout the study period. All animals showed expected gain in bodyweight over the study period. No abnormalities were noted at necropsy. The combined oral LD50 was considered to be greater than 2000 mg/kg bw.

 

The oral LD50 for CHIMEXANE NB - Batch M 824 is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).