Registration Dossier

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:
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Dose-related increase in apathy, discoordination, anormal posture, cyanosis, piloerection, and slightly reduced respiration
Body weight:
After 4 d, surviving animals appeared to have recovered to normal and showed normal weight gain.
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