Distillates (petroleum), cracked, ethylene manuf. by-product, C9-10 fraction

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

occlusive dressing used

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EPA Fed Reg Vol 50, No. 188 1985 and as amended in Fed Reg Vol 52, No. 97, 1987

Deviations:

yes

Remarks:

occlusive dressing used

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

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 267-333g; females 167-177 g
- Housing: Individually in stainless steel cages with wire screen bottoms and fronts.
- Diet: Cereal based, open formula basal diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes: 10 per hr
- Photoperiod: 12hrs dark / 12hrs light

IN-LIFE DATES: From: 29 June 1989 To: 13 July 1989

Administration / exposure

Type of coverage:

occlusive

Vehicle:

maize oil

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk, dorsal, ventral sides and flanks
- % coverage: Not reported
- Type of wrap if used: plastic film, secured by an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansed with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bodyweight
- Concentration (if solution): 20% w/v dilution in maize oil
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg

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 and no significant signs of toxicity at only dose tested

Mortality:

None

Clinical signs:

other: After 1 and 4 hours, all animals showed moderate signs of sluggishness. After 4 hours all males and 3 females showed moderate soiled fur. No signs of skin irritation were seen.

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 dermal LD50 of "cracked distillate" is in excess of 2000 mg/kg body weight to male and female rats.

Executive summary:

The acute dermal toxicity of cracked distillate (CAS 68477-40-7) was investigated in groups of 5 male and 5 female rats. A single 24 hour application of 2000 mg/kg in corn oil (20% w/v at 10 mL/kg) was applied under an occlusive dressing.

There were no mortalities and no significant signs of toxicity. It can be concluded that the LD50 of cracked distilled (CAS 68477 -40 -7) is > 2000 mg/kg and no classification is warranted under Dir 67/548/EEC or under GHS/CLP.