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Toxicological information

Acute Toxicity: dermal

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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal 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
Molecular formula:
not applicable
IUPAC Name:
Creosote
Test material form:
liquid
Details on test material:
- Test material quality: Creosote Type WEI B (Grade B)
- Substance type: organic
- Analytical purity: not applicable (UVCB substance, distilled coal tar, complex hydrocarbon mixture)
- Impurities (identity and concentrations): not applicable
Specific details on test material used for the study:
- Name of test material (as cited in study report): Creosote SNCF
- Type of test material: Creosote Type WEI B (Grade B)
- Analytical purity: not applicable (UVCB, distilled coal tar, complex hydrocarbon mixture)
- Impurities (identity and concentrations): not applicable
- Source and lot/batch No.of test material: Batch No.4460 A 93
- Storage condition of test material: Stable at room temperature under exclusion of UV light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69210 L´Arbresle, France
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 258 ± 11 g, females: 222 ± 5 g
- Fasting period before study: none
- Housing: polycarbonte cage, 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): approx. 13
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 - 35 cm²
- % coverage: about 10 % of the animals´ total surface
- Type of wrap if used: gauze and bandage semiocclusive

TEST MATERIAL
- Amount applied (volume or weight with unit): 1.91 mL/kg bw
Duration of exposure:
24 h
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: day 0, 5, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limit test
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limit test
Mortality:
none
Clinical signs:
No particular findings
Body weight:
No effects
Gross pathology:
No local reactions at the site of application; no abnormalities observed following macroscopic examination of organs
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
as well as EU criteria according to CLP regulation
Conclusions:
Based on the results of this study, the acute dermal LC50 (exposure period 24 h) of the test substance creosote SNCF, WEI-Type B was > 2000 mg/kg bw.