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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1995-07-05 to 1995-11-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because the study was carried out according to or closely followed OECD 401 guideline and was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons
EC Number:
700-762-0
Molecular formula:
All molecules present in the mixture have the general molecular formula CnH2n for olefins or CnH2n+2 for the paraffin’s with n being an even number
IUPAC Name:
C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
other: Crl: CDBR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Age at study initiation: Young adult
- Weight at study initiation: Between 248 to 295 grams
- Housing: Individual, suspended wire-mesh cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 degrees
- Humidity (%): 44.7 to 53.1%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6.6 mL/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
five males and five females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: 1, 3, and 4 hours after administration. Twice daily there after, for 14 days. Body weights were obtained and recorded on study days -1, 0 (initiation), 7 and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs were observed. The major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.
Statistics:
No data reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Mortality:
All animals survived until necropsy.
Clinical signs:
Clinical examination indicated that all rats had yellow urogenital and/or ventral abdominal staining on the day of dosing and/or 1 day after. Six animals were observed to have hair loss in the urogenital, ventral abdominal and/or hindlimb areas from days 5 to 14. Three rats had dried red material around the nose. However, all animals were reported to appear normal after day 2.
Body weight:
No changes in body weights were reported by the study authors.
Gross pathology:
One male was found to be missing the coagulating gland. The authors considered this to be a congenital abnormality and not related to the test material. Four rats were observed to have hair loss at the scheduled necropsy. No other necropsy findings were reported by the authors from all examined tissues.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on these study results, the authors concluded that the LD50 of NEODENE®13 INTERNAL OLEFIN is greater than 5,000 mg/kg when the test chemical is administered via gastric intubation, as a single dose, to fasted male and female albino rats.
Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for Category C isomerised olefins using tridecene as an analogue. Tridecene is an isomerised olefin; however, it is not a substance covered under the Higher Olefins and Poly Alpha Olefins Consortium. Therefore, tridecene’s chemical structure, as well as mammalian health endpoints, are comparable to other Category C isomerised olefins. Therefore, read across between tridecene and Category C isomerised olefins can be justified.

In an acute oral toxicity study, groups of young adult, fasted, albino rats (5 male, 5 female) were given a single oral dose of Neodene 13 Internal Olefin, at dose 5,000 mg/kg bw and observed for 14 days.

There were no treatment related clinical signs, necropsy findings or changes in body weight. The oral LD50 was determined to be 5,000 mg/kg bw in both males and females.

This study received a Klimisch score of one and is classified as reliable without restriction because the study was carried out according to or closely followed OECD 401 guideline and was GLP compliant. This study will influence the DNEL(s).