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Toxicological information

Acute Toxicity: dermal

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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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressing used
Qualifier:
according to
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. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
All lost weight from day 0-3, but subsequently gained weight at a normal rate.
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.