Reaction mass of 2-hydroxyethyl ricinoleate and (R)-12-hydroxyoleic acid, monoester with glycerol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978 June - October

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Test performed by nationally accredited lab with well-defined protocol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.40

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxyethyl ricinoleate

EC Number:

203-369-8

EC Name:

2-hydroxyethyl ricinoleate

Cas Number:

106-17-2

Molecular formula:

C20H38O4

IUPAC Name:

2-hydroxyethyl 12-hydroxyoctadec-9-enoate

Constituent 2

Reference substance name:

2,3-dihydroxypropyl 12-hydroxy-9-octadecenoate

EC Number:

205-455-0

EC Name:

2,3-dihydroxypropyl 12-hydroxy-9-octadecenoate

Cas Number:

141-08-2

Molecular formula:

C21H40O5

IUPAC Name:

2,3-dihydroxypropyl 12-hydroxyoctadec-9-enoate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: NL Industries
- Expiration date of the lot/batch: Lot # 60-8313-01
- Purity test date: N/A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Not reported
- Stability under test conditions: Assumed to be stable
- Solubility and stability of the test substance in the solvent/vehicle: N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Used as received
- Preliminary purification step (if any): None
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: N/A

FORM AS APPLIED IN THE TEST (if different from that of starting material) : 5000 mg/kg

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) : N/A

OTHER SPECIFICS:

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Summit View Farms, Belvidere, New Jersey
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Not reported
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 hr
- Housing: N/A
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: Not reported, To: 1978-08-29

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE: N/A, Substance was used as received

MAXIMUM DOSE VOLUME APPLIED: Not reported

DOSAGE PREPARATION (if unusual): N/A

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

5000 mg/kg

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 and weighing: Initially and at termination of the study
- Necropsy of survivors performed: Yes
- Other examinations performed: Gross organ pathology at the end of post-dosing observation period.

Statistics:

N/A

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

No clinical signs

Body weight:

Normal weight gain

Gross pathology:

No changes in gross pathology

Any other information on results incl. tables

Observation period (N = Normal)

0 -1 hr	1 -3 hr	3 -6 hr	6 -24 hr	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7 -14	Cumulative
10N	10N	10N	10N	10N	10N	10N	10N	10N	10N	10N

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was evaluated for acute oral toxicity according to 16 CFR 1500.40. The test substance was observed to be non-toxic in Sprague-Dawley rats at doses up to 5000 mg/kg.