C4-C10 branched and linear hydrocarbons (light) – Naphtha

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

repeated dose toxicity: inhalation

Remarks:

other: no data

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

IUCLID data have not undergone any evaluation by the European Commision - but due to the presence of n-hexane in the test material 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' (up to 6%), it should be classified as "Xn; R48/20" [n-hexane (concentration >=5%) is classified in the EU as "Xn; R48/20"].

Data source

Reference

Reference Type:

other: IUCLID Dataset

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: procedure as detailed in paper by Halder et al.

Deviations:

not specified

Principles of method if other than guideline:

procedure as detailed in paper by Halder et al. (Halder, C.A., Warne, T. M. and Hatoum, N.S., Renal toxicity of gasoline and related petroleum naphthas in male rats. In: Advances in Modern Environmental Toxicology, Vol VII: Renal effects of petroleum hydrocarbons, Princeton Scientific, Princeton, NJ, 1984)

GLP compliance:

not specified

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Substance type: test substance 'Naphtha (petroleum), light alkylate' is a near analogue to 'Naphta (Fischer-Tropsch), light, C4-10 - branched and
linear'; it`s defined as:
'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers
predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'
--> the test substance is comparable to 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear'

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

other: no data

Remarks on MMAD:

MMAD / GSD: no data

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

21 d

Frequency of treatment:

6h per day for 5 days per week

No. of animals per sex per dose:

test groups: - 1.54 mg/l: 10 male and 10 female animals
- 4.92 mg/l: 10 male and 10 female animals
- 15.31 mg/l: 10 male and 10 female animals

negative control group (no treatment): 10 male and 10 female animals

Control animals:

yes, concurrent no treatment

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

15.31 mg/L air

Sex:

male/female

Basis for effect level:

other: no data

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

In this study no systemic effects were found in female animals, but male animals displayed light hydrocarbon nephropathy. There was a 100% incidence of tubular dilation and necrosis at the corticomedullary junction of the kidneys in male rats for all three exposure groups. According to the guideline (Annex VI of Council Directive 67/548/EEC), "Xn; R48/20" should be applied for the test substance 'Naphtha (petroleum), light alkylate' --> 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' should be also classified as "Xn; R48/20".
Furthermore, due to the presence of n-hexane in the test material 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' (up to 6%) it should be classified as stated above [n-hexane (concentration >= 5%) is classified in the EU as "Xn; R48/20"].