Branched and linear octadecanoic acid, esters with glycerol oligomers

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 Aug - 20 Aug 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

/ no information on body weights were given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 Feb 1987

Deviations:

yes

Remarks:

/ no information on body weights were given

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, USA
- Fasting period before study: animals were fasted for 4 h prior to administration
- Housing: group caged (5 animals per cage, separated regarding sex) in wire mesh cages. The cages and feeders were sanitized every two weeks.
- Diet: Wayne Lab Blox, ad libitum
- Water: tap water, ad libitum (analysis was performed)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 6 Aug To: 20 Aug 1990

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.4 mL/kg bw

- Rationale for the selection of the starting dose: as requested from sponsor

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Remarks:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observation: immediately,1 and 4 h after gavage and thereafter daily for 14 days
weighing: at day 1 and day 14
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis were performed.

Results and discussion

Preliminary study:

No preliminary study was performed.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: On Day 1 (4 h /24 h) and Day 2 and 3 decreased activity was observed in one male animal. From Day 4 to Day 14, no clinical signs were observed in any of the animals.

Gross pathology:

Necropsy revealed that one male had a small left testis. The rest of the animals showed no abnormal gross findings in the examined organs and tissues.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified