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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

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:
yes

Test material

Constituent 1
Reference substance name:
Creosote
EC Number:
232-287-5
EC Name:
Creosote
Cas Number:
8001-58-9
IUPAC Name:
8001-58-9
Constituent 2
Reference substance name:
A complex combination of monocyclic aromatic hydrocarbons, polycyclic aromatic hydrocarbons, tar acids and tar bases, obtained by the distillation of coal tars produced by the high-temperature destructive distillation of bituminous coal to form coke. It consists of hydrocarbons boiling in the range of approximately 200°C-355°C
IUPAC Name:
A complex combination of monocyclic aromatic hydrocarbons, polycyclic aromatic hydrocarbons, tar acids and tar bases, obtained by the distillation of coal tars produced by the high-temperature destructive distillation of bituminous coal to form coke. It consists of hydrocarbons boiling in the range of approximately 200°C-355°C
Details on test material:
- Name of test material (as cited in study report): Product number 103.206
- Creosote Type WEI B
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Analytical purity: not applicable (UVCB, distilled coal tar, complex hydrocarbon mixture.)
- Impurities (identity and concentrations): not applicable
- Composition of test material, percentage of components: no data
- Storage condition of test material: Stable at room temperature under exclusion of UV light

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, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males: 160 – 201 grams, females: 160 – 231 grams
- Housing: 5 rats per cage (Macrolon)
- Fasting period before study: 16 h
- Diet: ad libitum until 16 h pre-application and continued from 4 h post-application
- Water: ad libitum
- Acclimation period: =< 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2
- Humidity (%): 50 - 85
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg


Doses:
3138; 3668; 4184; 5230 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: 15 and 45 min, 1, 2 and 3 h, 6 h, 24 and 48 h, 3 and 5 d p.a
Frequency of weighing: day 0 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Probit analysis according to Finney DY (1971)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 030 mg/kg bw
95% CL:
3 642 - 4 505
Mortality:
see below "Remarks on results..."
Clinical signs:
other: Dose-related increase in apathy, discoordination, anormal posture, cyanosis, piloerection, and slightly reduced respiration
Gross pathology:
No particular organ effects reported in deceased and sacrificed animals. No significant macroscopic abnormalities were found at necropsy.
Residues of test material were found in the gastro-intestinal tract of moribund and deceased animals.

Any other information on results incl. tables

MORTALITY

Dose[mg/kg]

24 h

48 h

3-14 days

Mortality (%)

Male

female

Male

female

Male

female

Male

female

3138

0/5

0/5

0/5

1/5

0/5

1/5

0

20

3668

0/5

1/5

1/5

2/5

1/5

2/5

20

40

4184

0/5

2/5

2/5

4/5

2/5

4/5

40

80

5230

1/5

4/5

3/5

5/5

4/5

5/5

80

100

The oral LD50 for creosote in rats was 3500 – 4000 mg/kg bw for males and females.

Applicant's summary and conclusion