Reaction mass of 2-octyldodecyl 2-hydroxypropanoate, 2-Octyldodecan-1-ol and 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25. October - 8 November 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Age of animals at study beginning is below 8 weeks, the animals are of mixed sex, body weight determined only at start and end of the study.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-octyldodecan-1-ol; 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate; 2-octyldodecyl 2-hydroxypropanoate

EC Number:

700-839-9

IUPAC Name:

2-octyldodecan-1-ol; 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate; 2-octyldodecyl 2-hydroxypropanoate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Cosmol 13
- Substance type: organic
- Physical state: liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 1-8-A

Specific details on test material used for the study:

Lot-No. 1-8-A

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation:6 - 8 weeks
- Weight at study initiation: 211 - 241 g
- Fasting period before study: 24 hours
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ab libitum
- Water (e.g. ad libitum): ab libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65° - 75° F
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
-no vehicle

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
a limit test was conducted

Doses:

2000mg/kg

No. of animals per sex per dose:

2 males, 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at start and at end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

no statistics performed

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: No abnormal signs observed.

Gross pathology:

No gross changes observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance did not show toxic effects during the study.

Executive summary:

Five (2M:3F) albino rats, 211 - 241 g, each recieved a single oral dose of the test article at a dose of two (2) grams per kilogram body weight. Animals were observed for pharmacological activity and drug toxicity 1, 3, 6, and 24 hours after treatment. All animals survived the observation period and were then euthanized and subjected to a gross necropsy with all findings noted. The test article was used as recieved (Sp.g. = 0.88).