Alkenes, C13-14, hydroformylation products, low boiling

Acute Toxicity: oral

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:

2012-07-17 until 2012-08-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, according to the guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C11-12, hydroformylation products, low boiling

IUPAC Name:

Alkenes, C11-12, hydroformylation products, low boiling

Constituent 2

Reference substance name:

Alchisor TAL 123

IUPAC Name:

Alchisor TAL 123

Details on test material:

- Name of test material: Alchisor TAL 123
- Composition of test material: Alkenes, C11-12, hydroformylation products, low boiling
- Substance type: not mentioned
- Physical state: liquid
- Analytical purity: 100 %
- Lot/batch No.: Teste Lial 123 - mix TC671-681-20/06/2012
- Expiration date of the lot/batch: 2013-06-25
- Storage condition of test material: room temperature, protected from light
- Other: Not mentioned

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 9-10 weeks
- Weight at study initiation: female: 145 - 178 g
- Fasting period before study: 16 - 19 h (access to water was permitted)
- Housing: in groups in IVC cages, type III H, polysulphone cages
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice
- Water: ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: at least 5 days
The animals were non-pregnant and nulliparous.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 1. step: 1.5 g of the test item were dissolved in the vehicle to gain a final volume of 7.5 ml, 2. step: 2 g of the test item were dissolved in a final volume of 10 ml, dose volume: 10 mL/kg body weight
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characterics
- Lot/batch no. (if required): Sigma Aldrich, lot MKBH489V, expiry date 10/2012
- Purity: not mentioned

Doses:

2000mg/kg

No. of animals per sex per dose:

6 (3 in each of the 2 steps)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 prior to the administration and on days 8 and 15. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrified by an over-dosage of phenobarbital.
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Not performed

Results and discussion

Preliminary study:

not mentioned

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: All animals showed slight piloerection. 3 of the 6 animals showed slightly reduced spontaneous activity and half eyelid-closure. From day 2 until the end of the observation period all animals had no signs of toxicity.

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Other findings:

- Organ weights: Not reported
- Histopathology: Not reported
- Potential target organs: Not reported
- Other observations: Not reported

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No animal died. The LD50 was > 2000 mg/kg body weight. Therefore according to CLP the substance is not classified.

Executive summary:

The median lethal dose of Alchisor TAL 123 after a single oral administration to female rats, observed over a perid of 14 days is LD50 > 2000 mg/kg. At a dose of 2000 mg/kg there was seen slight piloerection in all animals and other signs of toxicity in three of the six animals (slightly reduced spontaneous activity, half eyelid-closure).