Hexacos-1-ene

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:

1992-06-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted according to GLP and followed guidelines (OECD 401, U.S. EPA/TSCA) that were acceptable at the time the study was performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexadec-1-ene

EC Number:

211-105-8

EC Name:

Hexadec-1-ene

Cas Number:

629-73-2

IUPAC Name:

hexadec-1-ene

Details on test material:

- Name of test material (as cited in study report): Gulftene 16
- Test substance: C16 alpha olefin
- Physical state: Liquid, colourless, low viscosity
- Composition of test material, percentage of components:
100% Gulftene 16
(93.0% 1-hexadecene, 2% 2-Ethyl-1-Tetradecene, 2% 2-Butyl-1-Dodecene, 2% 2-Hexyl-1-Decene, and 1% Hexadecene-N)
- Storage condition of test material: Stored in room temperature in a chemical storage cabinet

Test animals

Species:

other: rat, albino

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley, Incorporated
- Age at study initiation: 7 to 13 weeks
- Weight at study initiation: 200 to 299 grams
- Fasting period before study: 18 hours
- Housing: Separated by sex, 5 per cage, housed in wire floor cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 to 74
- Humidity (%): 45 to 56
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100% Gulftene 16 (93% hexadecene-1)
MAXIMUM DOSE VOLUME APPLIED: 10 g/kg

Doses:

5 g/kg and 10 g/kg; individual doses were adjusted according to rat body weight.
10 g/kg: (Dose did not exceed more than 1.0 millilitre per 100 grams of body weight.) This dose level was split into two administrations, with one hour between doses.

No. of animals per sex per dose:

5 male and 5 female dosed at 10 g/kg
5 male and 5 female dosed at 5 g/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1, 2 and 14 days (additional observations were made is suggested by Neurotoxicologist.)
- Frequency of observations and weighing: Weighing occurred at 7 and 14 days after dosing.
- Necropsy of survivors performed: Yes

Statistics:

None reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

10 g/kg dose - 2/5 males and 2/5 females died
No lethality was observed at 5 mg/kg bw in either sex.

Clinical signs:

other: Several reported clinical signs were linked to excessive excretion of the compound including red extremities, unkempt appearance, discharge on perineal fur, greasy wet perineal fur and hindlimb regions, and alopecia and scabs on the perineal fur, hind lim

Gross pathology:

Necropsy revealed discoloration in lungs, intestines (with distention), liver (1 animal) and kidneys in rats that died or were sacrificed during the study period. Surviving animals had no remarkable gross lesions. No lesions were found in tissues taken to evaluate neurotoxicity (brains, spinal cords, sciatic nerves and pituitaries.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU

Conclusions:

No histopathological signs of lesions were found in the central or peripheral nervous system. Clinical signs were not considered to be related to the irritation of the abdominal and hindlimb areas. Based on these results, Gulftene 16 did not appear to produce primary neurotoxicant effect.

Executive summary:

In an acute oral toxicity study, two groups of 10 (male and female) Sprague-Dawley albino rats, 7 to 13 weeks of age, which had fasted for 18 hours, were given a single oral dose of Gulftene 16 at 10 g/kg or 5 g/kg. These animals were observed for a total of 14 days.

There was no treatment related clinical signs, necropsy findings or changes in body weight. The oral LD50 was determined to be 10 g/kg bw in both males and females.

This study received a Klimisch score of 1 and is classified as "reliable without restriction" because it was conducted according to GLP and followed guidelines (OECD 401, U.S. EPA/TSCA) that were acceptable at the time the study was performed.