Registration Dossier

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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

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:
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.
Body weight:
All gained weight after 3 days.
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.