Nitriles, C16-18

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2 Jan - 16 Jan 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Purity not indicated. Read-across from structural identical substance with same chain length distribution but with some level of unsaturation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

EPA guidelines OTS Aug. 1982

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tallownitrile

IUPAC Name:

Tallownitrile

Details on test material:

Name: Arneel TMD, Lot #7526501
Physical state: Pale Yellow Liquid
pH = 2.0; retested (checked: see attached letter to report: pH is 6.7, well within normal range of product)
Spec.gravity: 0,83
Analytical certificate:
H2O: 0.02
Gardner color: <1
IV: 52.8
A.V.: 0.10
S+A: 0.23
pH of 10% in 1:1 ethanol/water: 6.7

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: received from Ace Animals on 12/10/85
- Age at study initiation: approx. 8 wks
- Weight at study initiation: The pretest weight range was 272-298 9 for males and 238-250 g for females.
- Fasting period before study: 16-12 hrs before dosing
- Housing: 5/sex/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5012)
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):" temperature controlled"
- Humidity (%): "humidity controlled"
- Air changes (per hr): not indicated.
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: Animal received 10 Dec 1985. Test From: 2 Jan 1986 To: 16 Jan 1986

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Single dosing by syringe and dosing needle.

Doses:

5.0 g/kg.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2 and 4 hours post dose and once each morning and afternoon thereafter for 14 days for mortality toxicity and pharmacological effects.
- Frequency of weighing: Body weights were recorded immediately pretest, weekly, and at termination in the survivors.
- Necropsy of survivors performed: yes: All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.

Statistics:

Not applicable as no mortality occurred. The LD 50 was considered to be greater than 5.0 g/kg if there was no compound related mortality at the 5.0 g/kg level.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality at limit dose

Mortality:

No mortality occurred

Clinical signs:

other: Oily appearance of body surfaces were noted during the study, and one male animal had respiratory rales on Day 6. All animals appeared normal from Day 7 through Day 14.

Gross pathology:

Eight animals (5 males and 3 females) were normal. In two females abnormalities were noted: One showed few yellow areas on the intestines, and an abnormality of the left ovary in another animal.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

No mortally, and only limited toxicity occurred at 5 mg/kg bw

Executive summary:

In a standard LD50 limit study, no mortality was observed following the oral application of 5 g/kg of tallow nitrile to 5 male and 5 female rats. Only limited toxicity was observed consisting of oiily appearance of body surfaces were noted during the study, and one male animal had respiratory rales on Day 6. All animals appeared normal from Day 7 through Day 14.

One female showed a decrease of BW in the course of the second week. All other body weights were normal.

At necropsy 14 days after dosing one female showed few yellow areas on the intestines, and an abnormality of the left ovary was noted in another animal.