Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jul. - 14 Aug. 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
only female animals under study
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised
EC Number:
701-299-7
Molecular formula:
not applicable (depends on the monomers; see "Structural formula")
IUPAC Name:
Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised
Test material form:
liquid: viscous
Details on test material:
- Manufacturers identification: Novares TL 10, Novares L 100, Novares L 800, Novares C 10 (different types/technical products of the substance)
- Substance type: organic
- Test material is 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised', EC list number 701-299-7 (assigned by ECHA after request for change of EC number/EC name). Originally, the substance Hydrocarbons, C9-unsaturated, polymerised, CAS No. 71302- 83-5, was submitted for registration. Subsequent to substance validation, the identity of the substance was changed by ECHA (EC number 615-276-2 and new name 'Distillates (petroleum), steam-cracked, C8-12 fraction", mainly C8 - C10 unsaturated aromatic and alkylaromatic hydrocarbons, predominantly styrene- and indene-derivatives, obtained by Lewis acid-initiated alkylation and polymerisation').
- for additional information see respective study records
Specific details on test material used for the study:
- Name of test material (as cited in study report): Novares L 100; CAS-no. 71302-83-5 (Hydrocarbons, C9- unsaturated, polymerized)
- Composition of test material, percentage of components: see Section 1.2 Composition
- Lot/batch No.: 24106
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen/Germany
- Age at study initiation: young adult
- Weight at study initiation: 165 - 209 g
- Fasting period before study: overnight
- Housing: cages
- Diet: ad libitum, except 3 - 4 h after treatment
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 g/10 mL
- Amount of vehicle (if gavage): ~8 mL/kg bw
- Justification for choice of vehicle: miscible with the TS
- Lot/batch no. (if required): 066K0057 (Sigma Chemicals Co.)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7, and 14 d
- 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:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: diarrhoea in 2/6 animals after 1 - 2 days post-application
Gross pathology:
no particular findings
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
according to Regulation (EC) 1272/2008 (CLP regulation) no classification required
Conclusions:
The test material 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised' (technical product L 100) did not cause any mortality in an acute oral toxicity test (OECD 423, acute toxic class method) at the limit concentration of 2000 mg/kg bw. The LC50 was determined to be > 2000 mg/kg bw.