Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
standard acute oral test
GLP compliance:
no
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): SBP 100/140
- Analytical purity: 100% pure commercial product
- Composition of test material, percentage of components: low aromatic content solvent consisting of about 35% C7, 50% C8 and 15% C9 saturated hydrocarbon isomers

Before the current ECHA nomenclature rules became effective, we adopted the IUPAC name Hydrocarbons, C7-9, n-alkanes, isoalkanes, cyclics (EC number 920-750-0) as the identifier for the substance and this was the name that was used during the pre-registration phase of REACH. Also during this time, samples of the product were collected and the required physicochemical studies were conducted. The resulting robust studies summaries were entered into the IUCLID dossier using this name and EC number.

Between 2008 and 2009 ECHA issued a specific document about the nomenclature to be used under REACH, the so called REACH Implementation Project 3.10. The implications of this document to the appropriate nomenclature for the registered substance were only fully understood by us beginning in late 2009/early 2010.

As such, during the creation of the robust study summaries in IUCLID, the discrepancy with the substance naming was not noticed. As a result, it appears in IUCLID that the tested substance indicated is not the same as the registered one; however, if robust study summaries and/or associated study reports use the substance name “Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics,” they are actually referring to the registered substance “Hydrocarbons, C7-C8, n-alkanes” according to the revised REACH nomenclature rules.

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent
- Age at study initiation: approx. 12 weeks
- Fasting period before study: on night before test
- Housing: 4 animals of one sex in a cage
- Diet (e.g. ad libitum): ad libitum after dosing
- Water (e.g. ad libitum): ad libitum after dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1, 2, 4, and 8 mL/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 9 days

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 8 mL/kg bw
Mortality:
No mortality occurred in any test animal over the 9-day observation period.

Any other information on results incl. tables

Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU, GHS, 2007
Conclusions:
The purpose of this study was to determine the acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 is > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw. The test substance is not classified according to OECD GHS guidelines.
Executive summary:

The purpose of this study was to determine the acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 is > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw. The test substance is not classified according to OECD GHS guidelines.