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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 26 April 1984 to 10 May 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted by a GLP accredited laboratory using a method similar to OECD Testing Guideline 402 and meets acceptable scientific standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
2 males and 2 females had the shaved area abraded, instead of using 5 animals/sex with intact skin.
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Distillates (petroleum), light catalytic cracked
EC Number:
265-060-4
EC Name:
Distillates (petroleum), light catalytic cracked
Cas Number:
64741-59-9
IUPAC Name:
64741-59-9
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Light catalytic cracked distillate (petroleum)
- Substance type: Hydrocarbons having carbon numbers predominantly in the range of C9 through C25. Also contains relatively large portion of bicyclic aromatic hydrocarbons
- Physical state: Light brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc
- Age at study initiation: approx. 14 weeks
- Weight at study initiation: 2,213-2,565g
- Diet: ad libitum Purina certified Rabbit chow f5322
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 42-74%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The back of the abdomen
- % coverage: approx. 10%
- Type of wrap if used: Saran wrap and Elastoplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with wet disposable towels (not washed) as thoroughly as possible without irritating the skin
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
4 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: hourly for first 6 hours after dosing, then daily for dermal irritation, and twice daily for clinical signs and mortality
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None observed
Clinical signs:
other: All animals appeared normal throughout the study duration
Gross pathology:
The skin of the test area was thickened in one of the males and two of the females

Any other information on results incl. tables

Average body weights (g)

 Dose level (mg/kg) Initial   Day 7 Terminal  Mortality (number dead/number dosed) 
             Male
 2000 2391  2500  2696  0/2 
 2000 2326  2385  2573  0/2 
             Female
 2000 2495  2456  2698  0/2 
 2000 2389  2450  2669  0/2 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the male and female New Zealand white rabbit strain was estimated to be greater than 2000 mg/kg body weight for both sexes. It did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

The acute dermal toxicity of light catalytic cracked distillate was tested in male and female New Zealand white rabbit using a method similar to the OECD Guideline for Testing of chemicals 402. Dosage levels were 2000 mg/kg for both male and females. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. At dose level 2000 mg/kg there was no mortality, no signs of systemic toxicity noted during the observation period and the animal showed expected gains in body weight over the observation period. No mortality was observed and at necropsy one of the males and 2 females showed thickened skin.The acute oral median lethal dose (LD50) of the test item in the male and female male and female New Zealand white rabbit was estimated to be greater than 2000 mg/kg body weight. It did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

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