Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 September 1982 - 20 October 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

GLP-like (QA signature) with limited information on individual animals

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: 16 CFR 1500.3 Federal Hazardous Substances Act Regulations.

Deviations:

no

GLP compliance:

yes

Remarks:

GLP-like (QA signature)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine

EC Number:

294-785-9

EC Name:

Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine

Cas Number:

91770-03-5

IUPAC Name:

Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Weight at study initiation: average weight between 200~300 g.
- Fasting period before study: Feed (not water) was withheld overnight prior to dosing.
- Housing: The animals were housed and maintained in accordance with the Animal Welfare Act 9 CFR Part Stainless steel with elevated wire mesh flooring; 3 - 5 rats/cage by sex
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1982-09- 10 To: 1982 -09-24

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

MAXIMUM DOSE VOLUME APPLIED: No data. Volume seleted to deliver dose of 5000 mg/kg bw

DOSAGE PREPARATION (if unusual): Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosage and twice daily thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter and prior to sacrifice.
- Necropsy of survivors performed: gross necropsies were performed on all animals that either died during the 14 day observation period or on surviving animals that were sacrificed at the conclusion of the 14 day observation period.

Statistics:

No data available

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities

Clinical signs:

other: The animals had ruffled fur after 3 hours. They appeared normal within 24 hours and throughout the remainder of the observation period.

Gross pathology:

No gross abnormalities were noted in all animals.

Any other information on results incl. tables

Table 1. Results

Dose Level (mg/kg)		5000
Sex		Male	Female
Average Body Weight (g)	Initial	243	218
	7 d	298	248
	14 d	344	243
Mortality (No. death/No. dosed)		0/5	0/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The test article, when administered as received to male/female Sprague-Dawley rats, had an acute oral LD50 of greater than 5000 mg/kg bodyweight

Executive summary:

Test Guidance

Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations.

Method and Material

A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals.

Results

There were no mortalities or signs of clinical toxicity.

Conclusion

The acute oral LD50 in male and female rats was determined to be > 5000 mg/kg bw.