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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-06-17 to 1982-07-1
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it is a GLP study and is in compliance with OECD Guideline 423.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1982-06-17 to 1982-07-1
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it is a GLP study and is in compliance with OECD Guideline 423.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Specific details on test material used for the study:
- Name of test material (as cited in study report): Gulftene 20-24
- Substance type: C20-24 alpha olefin
- Physical state: Solid
- Analytical purity: 100%
- Stability under test conditions: Stable according to Material Safety Data Sheets, not under conditions of administration
Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Age at study initiation: 14 to 19 weeks
- Weight at study initiation: 166 to 265 grams
- Fasting period before study: 1 day
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 43 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 60%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: 1982-05-05 To: 1982-07-01
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% weight/volume
- Amount of vehicle (if gavage): 30.00 millilitres

MAXIMUM DOSE VOLUME APPLIED: 2 mL/100 g
Doses:
5000 mg/kg bw
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: Twice daily, once daily on weekends
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, necropsy
Statistics:
No statistical analyses were performed as none were required to achieve the objective of the study.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Based on lack of mortality
Mortality:
No animals died after administration of the test substance.
Clinical signs:
Yellow staining in inguinal region was experienced by all test animals after dosing, but this sign disappeared by the third study day. One animal had brown staining on its lower jaw for the first 4 days, and two animals had oil around their mouths immediately after dosing.
Body weight:
No adverse effects were noted in body weight gains.
Gross pathology:
No adverse effects were noted as a result of the test material.

The LD50 was determined to be > 5000 mg/kg bw based on a lack of mortality in male and female rats.

Interpretation of results:
other:
Remarks:
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:
The LD50 was determined to be > 5000 mg/kg bw based on a lack of mortality in male and female rats.
Executive summary:

In an acute oral toxicity study, groups of fasted, 14 to 19 week old Fisher 344 rats (5/sex) were given a single oral dose of alpha olefin C20-24 in corn oil at a dose of 5000 mg/kg bw, and observed for 14 days.

No treatment-related adverse effects were noted in body weight or necropsy observations, and the only clinical signs noted (yellow staining of the inguinal region, oil around mouth, and brown staining on lower jaw) all disappeared by day 5 of the study period. The oral LD50 was determined to be > 5000 mg/kg in males and females.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is a GLP study and is in compliance with OECD Guideline 423.

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Gulftene 20-24
- Substance type: C20-24 alpha olefin
- Physical state: Solid
- Analytical purity: 100%
- Stability under test conditions: Stable according to Material Safety Data Sheets, not under conditions of administration
Specific details on test material used for the study:
- Name of test material (as cited in study report): Gulftene 20-24
- Substance type: C20-24 alpha olefin
- Physical state: Solid
- Analytical purity: 100%
- Stability under test conditions: Stable according to Material Safety Data Sheets, not under conditions of administration

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Age at study initiation: 14 to 19 weeks
- Weight at study initiation: 166 to 265 grams
- Fasting period before study: 1 day
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 43 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 60%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: 1982-05-05 To: 1982-07-01

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% weight/volume
- Amount of vehicle (if gavage): 30.00 millilitres

MAXIMUM DOSE VOLUME APPLIED: 2 mL/100 g
Doses:
5000 mg/kg bw
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: Twice daily, once daily on weekends
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, necropsy
Statistics:
No statistical analyses were performed as none were required to achieve the objective of the study.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Based on lack of mortality
Mortality:
No animals died after administration of the test substance.
Clinical signs:
Yellow staining in inguinal region was experienced by all test animals after dosing, but this sign disappeared by the third study day. One animal had brown staining on its lower jaw for the first 4 days, and two animals had oil around their mouths immediately after dosing.
Body weight:
No adverse effects were noted in body weight gains.
Gross pathology:
No adverse effects were noted as a result of the test material.

Any other information on results incl. tables

The LD50 was determined to be > 5000 mg/kg bw based on a lack of mortality in male and female rats.

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
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:
The LD50 was determined to be > 5000 mg/kg bw based on a lack of mortality in male and female rats.
Executive summary:

In an acute oral toxicity study, groups of fasted, 14 to 19 week old Fisher 344 rats (5/sex) were given a single oral dose of alpha olefin C20-24 in corn oil at a dose of 5000 mg/kg bw, and observed for 14 days.

No treatment-related adverse effects were noted in body weight or necropsy observations, and the only clinical signs noted (yellow staining of the inguinal region, oil around mouth, and brown staining on lower jaw) all disappeared by day 5 of the study period. The oral LD50 was determined to be > 5000 mg/kg in males and females.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is a GLP study and is in compliance with OECD Guideline 423.