Dodecene, hydroformylation products, high-boiling

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecene, hydroformylation products, high-boiling

EC Number:

271-239-8

EC Name:

Dodecene, hydroformylation products, high-boiling

Cas Number:

68526-91-0

Molecular formula:

Unspecified

IUPAC Name:

Reaction products of dodecene, hydroformylation products, high boiling

Details on test material:

- Test-item No.: 08/0016-3
- Batch identification: Tk253_20090901
- Purity Group 1: 18.5 area-%
Group 2: 7.5 area-%
Group 3: 71.2 area-%
Group 4: 2.5 area-%
= 99.7 area-%
- Homogeneity: The test-item was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage conditions: Room temperature, under N2
- Physical state/ color: Liquid/ colorless, clear

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: males (mean): 226.2 g; females (mean): 200.2 g
- Housing: Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 – 26
- Humidity (%): 20 – 80
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk; about 40 cm²
- % coverage: corresponds to at least 10% of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.31 mL/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Mortality: A check for any dead or moribund animal was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS