Solvent naphtha (petroleum), heavy arom.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction

EC Number:

270-729-9

EC Name:

Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction

Cas Number:

68477-40-7

IUPAC Name:

68477-40-7

Constituent 2

Reference substance name:

Cracked distillate

IUPAC Name:

Cracked distillate

Details on test material:

- Name of test material (as cited in study report): "Cracked distillate"
- Physical state: brown/green liquid
- Components: (by weight): - naphthalene (15-35), methylnaphthalene (5-10), 13-methylnaphthalene (5-10), di, tri, tetra-methylnaphthalene (< 5), paraffins (1-20), alkylbenzenes (< 5), indene, alkylindenes and alkylindanes (20-30), compounds with higher boiling points (< 5)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: males 131-153g; females 112-129 g
- Fasting period before study: overnight
- Housing: In groups of 5, sexes separately in stainless steel cages with wire screen bottoms and fronts.
- Diet: Cereal based, open formula basal diet ad libitum (except for overnight fast prior to dosing)
- Water: Tap water ad libitum
- Acclimatisation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Photoperiod: 12hrs dark / 12hrs light)

IN-LIFE DATES: From: 5 July 1989 To: 19 July 1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bodyweight

Doses:

2000 mg/kg bodyweight

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: Observations frequently during the first 4 hours and once per day thereafter. Bodyweights recorded on days 0, 3, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality at highest dose tested

Mortality:

None

Clinical signs:

other: After 1 and 4 hours all showed severe/moderate signs of sluggishness and moderate piloerection. After 24 hours 3 females showed moderate soiled fur. No signs at any other time.

Gross pathology:

No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of "cracked distillate" is in excess of 2000 mg/kg bodyweight.

Executive summary:

The acute oral toxicity of E000144600 (CAS 68477-40-7) was determined in a group of 5 male and 5 female rats administered a single dose of undiluted test substance at 2000 mg/kg. There was no mortality and all animals had gained weight on day 3. The acute oral LD50 of "cracked distillate" is in excess of 2000 mg/kg bodyweight to male and female rats. No classification is warranted under Dir 67/548/EEC or GHS/CLP.