Creosote oil, acenaphthene fraction

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Aug. - 03 Sep. 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24.2.1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Creosote oil, acenaphthene fraction

EC Number:

292-605-3

EC Name:

Creosote oil, acenaphthene fraction

Cas Number:

90640-84-9

Molecular formula:

not applicable

IUPAC Name:

1,1'-biphenyl; 1,2-dihydroacenaphthylene; 1-methylnaphthalene; 2-methylnaphthalene; 9H-fluorene; anthracene; naphthalene; pentacyclo[10.6.2.0²,⁷.0⁹,¹⁹.0¹⁶,²⁰]icosa-1(18),2,4,6,8,10,12,14,16,19-decaene; quinoline

Details on test material:

- Name of test material (as cited in study report): wash oil
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Stability under test conditions: WAF (water accommodated fraction) limited
- Storage condition of test material: room temperature, exclusion of light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: TOP VELAZ s.r.o., Koleč subsidiary
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: males: 193 g (range: 170 - 208 g) / females: 157 g (range: 150 - 165 g)
- Fasting period before study: ~20 h before treatment
- Housing: conventional, 5 per sex
- Diet: from 30 min post-application
- Water: ad libitum
- Acclimation period: >= 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 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: 2x/d (day 1 and 2), then 1x/d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: Hunched, lateral or prone posture, apathy, inappetence, cyanotic or pale skin and ischemic mucous membranes recovery within 2 d

Gross pathology:

Changes in the lung, more pronounced in female rats: focal emphysema, point-shaped dark-red foci
(indicating to vascular disorder expressed by ischemia peripheric tissues and organs (see lung) probably following a shock-like response).

Any other information on results incl. tables

Table 1: Male body weights (g) – 2000 mg/kg

Animal No.	Before administration	Day 8	Day 15	Increment
1	203.7	240.9	259.8	56.1
2	186.8	214.9	237.3	50.5
3	195.5	222.8	245.7	50.2
4	170.1	199.8	228.8	58.7
5	207.8	238.6	267.9	60.1
Average	192.8	223.4	247.9	55.1

Table 2: Female body weights (g) – 2000 mg/kg

Animal No.	Before administration	Day 8	Day 15	Increment
1	156.3	173	188.3	27
2	150.4	171	175.3	24.9
3	158.3	172	183.1	24.8
4	164.9	189	205.6	40.7
5	153.2	168	182.9	29.7
Average	156.6	174	187	29.4

Table 3: Pathological examination of the male and female rats – 2000 mg/kg

Animal No.	Autopsy finding
	males	females
1	No macroscopic changes	Lungs – dark-red dot-like foci
2	Lungs – emphysematous foci	Lungs – emphysematous foci
3	Lungs – dark-red dot-like foci	Lungs – dark-red dot-like foci
4	No macroscopic changes	Lungs – dark-red dot-like foci
5	No macroscopic changes	Lungs – dark-red dot-like foci