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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1984-04-26 to 1984-05-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and well documented study report.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
Substance as identified in the study report: API 83-07 (CAS# 64741-59-9)
Physical Description: light brown liquid
Initial Boiling Point (°F): 464
Final Boiling Point (°F): 701
Gravity API degrees: 14.1

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: 14 weeks old
- Weight at study initiation: 2213 to 2565 grams
- Fasting period before study: not reported
- Housing: individually housed in screen-bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 42 to 74%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1984-04-26 To: 1984-05-10

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped backs of the animals; test material was applied to intact skin of two males and two females; test material was applied to abraded skin of the remaining two males and two females
- % coverage: 10% of total body area
- Type of wrap if used: eight-ply gauze bandage, overwrapped with Saran wrap and Elastoplast tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean with disposable towel (not washed)
- Time after start of exposure: 24 hours after gauze application


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg based on body weight of animal at study initiation
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical signs and mortality were taken at hourly intervals for the first 6 hours after test material administration then twice daily thereafter until study termination. Dermal irritation was checked daily after test substance administration. Animals were weighed before fasting, just prior to test material administration, and 7 and 14 days after test material administration.
- 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: intact and abraded skin
Mortality:
No mortality occurred.
Clinical signs:
Dermal irritation ranged from slight to moderate erythema, desquamation, and coriaceousness. Moderate to severe oedema was observed, and slight to marked atonia and fissuring were observed. No systemic toxicity was noted.
Body weight:
No significant changes in body weight were observed.
Gross pathology:
No abnormal gross pathology was reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 is greater than 2000 mg/kg bw Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity LD50 is >2000 mg/kg in male and female rabbits which is not classified according to EU criteria.
Executive summary:

 In an acute dermal toxicity study, groups of young adult, New Zealand White rabbits (4/sex) were dermally exposed to light catalytically cracked distillate for 24 hours at a dose of 2000 mg/kg bw that covered 10% of the body surface area.  Animals were then observed for 14 days.

No mortality or systemic toxicity was observed. Dermal irritation ranged from slight to moderate erythema, desquamation, and coriaceousness. Moderate to severe oedema was observed, and slight to marked atonia and fissuring were observed. At necropsy, no significant gross pathological observations were noted. The dermal LD50 was determined to be greater than 2000 mg/kg in males and females which is not classified according to EU criteria.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and well documented study report.