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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
other: No particular findings
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.