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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
Study period:
1985-06-11 to 1985-12-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 402.

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:
Skin was abraded. Other deviations (initial body weights and humidity) are not considered to have had an effect on the validity of the study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
64741-44-2
Cas Number:
64741-44-2
IUPAC Name:
64741-44-2
Constituent 2
Reference substance name:
Straight run middle distillate
IUPAC Name:
Straight run middle distillate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 83-11
- Substance type: Straight run middle distillate
- Physical state: Clear, pale-yellow liquid
- CAS number: 64741-44-2
- Gravity API: 36.2
- Sulfur wt %: 0.30
- Nitrogen ppm: 80
- Boiling range (ASTM D-86 equiv) 10%: 488 °F
- Initial Boiling Point 366 °F
- End Boiling Point 735 °F
- Viscosity at 40°C cSt: 4.16
- Aniline Point °F: 171
- Composition % by MS:
olefins 2.0
aromatics 21.0
saturates 77.0

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. , Denver, Pennsylvania
- Age at study initiation: Approximately 14 weeks of age
- Weight at study initiation: Between 2,318 grams and 2,604 grams
- Housing: Individual cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
83-11 was dosed as received
Details on dermal exposure:
TEST SITE
- Area of exposure: Back of animal was exposed
- % coverage: Approximately 10%
- Type of wrap if used: Application area was wrapped with an eight-ply gauze bandage and overwrapped with Saran Wrap and Elastoplast tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Area was wiped but not washed.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
The animals were exposed for 24 hours.
Doses:
An individual dose at a level of 2000 mg/kg was weighed out for each animal based upon its body weight at the study initiation.
No. of animals per sex per dose:
Eight animals (four male and four female) were dosed.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed hourly for the first six hours after dosing, then daily for dermal irritation and twice daily for clinical signs and mortality for a period of 14 days. Body weights were taken just prior to administration, at 7 days, and at study termination.
- Necropsy of survivors performed: Yes
Statistics:
No data reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed at this dose level.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
Body weights increased in both sexes over the course of the study.
Gross pathology:
No visible lesions were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 is greater than 2000 mg/kg Criteria used for interpretation of results: EU
Conclusions:
Dermal irritation observed during the study ranged from slight to moderate for erythema, oedema, atonia, desquamation, and fissuring.
Slight coriaceousness was also seen.
Executive summary:

In an acute dermal toxicity study, 4 male and 4 female albino New Zealand rabbits were dermally exposed, under occlusion, to a Straight run middle distillate for 24 hours to approximately 10% of their body surface, at 2000 mg/kg bw. No sign of systemic toxicity or mortality was observed at this dosage level. Slight to moderate dermal irritation for erythema, oedema, atonia, desquamation, and fissuring, and slight coriaceousness were observed.

The dermal LD50 was >2000 mg/kg in males and females.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 402.

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