Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction

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: Acceptable, well-documented study report equivalent or similar to OECD guideline (402): GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction

EC Number:

701-314-7

Molecular formula:

CnH2n+2O2. n=24-33

IUPAC Name:

Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction

Details on test material:

- Name of test material (as cited in study report): MRD-85-608
- Physical state: yellow liquid
- Analytical purity: assumed 100%
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: males (2.26-2.34 kg), female (2.50-2.60 kg)
- Fasting period before study: n/a
- Housing: individually
- Diet (e.g. ad libitum): Purina certified rodent chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-70
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal surface from the shoulder region to the lumbar region
- % coverage: n/a
- Type of wrap if used: occlusive plastic over gauze


REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water and paper towels
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3160 mg/kg (3.63 ml/kg)
- Concentration (if solution): Assumed 100%
- Constant volume or concentration used: yes

Duration of exposure:

24 H

Doses:

3160 mg/kg (3.63 ml/kg based on a density of 0.87 g/ml)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 2 and 4 hours after dosing and daily thereafter for 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

The means and standard deviations of the body weights and body weight changes were calculated.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Remarks on result:

other: No deaths observed

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3.63 mL/kg bw

Remarks on result:

other: No deaths observed

Mortality:

No deaths observed.

Clinical signs:

other: Dermal exposure elicited well-defined to moderate-severe erythema in all animals at the 24 hour observation period. As the study progressed, these observations subsided. Nasal discharge, food comsumption decrease, staining in the ano-genital area, unthr

Gross pathology:

I animal had maloccluded incisors and 3 animals had alopecia. Three of the 6 test animals exhibited no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 for the registered substance is greater than 3160 mg/kg.

Executive summary:

The acute dermal irritation potential and systemic toxicity of the registered substance were evaluated in 6 male and female rabbits via the occluded patch method. A dose of 3160 mg/kg (3.63 ml/kg) was applied to the clipped backs of the rabbits for 24 hours. Following patch removal, observations occurred daily for 14 days to assess irritation and systemic toxicity. There were no animal deaths during the course of the study. The acute dermal LD50 for the registered substance is greater than 3160 mg/kg.