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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:
1990-08-06 to 1992-05-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was carried out according to EPA OTS 798.1100 and equivalent/similar to OECD TG 434.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Name of test material: F-133, thermocracked kerosene, CAS No. 68333-23-3
- Substance type:
- Analytical purity: 100% petroleum hydrocarbons
- Storage condition of test material: material was stored below 27 degrees celsius
- specific gravity- approximately 0.74
- Flash point- approximately -42 degrees celsius
- pH: 5
-Density: 0.8965 g/ml

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Western Oregon Rabbitry, Philomath, Oregon
- Age at study initiation: young adults
- Weight at study initiation: 2.0 to 3.5 kilograms at time of dosing
- Fasting period before study: no data provided
- Housing: house separately in stainless steel, wire mesh bottom cages
- Diet: fresh certified Agway Rabbit Feed was provided ad libitum
- Water: fresh potable water was provided ad libitum
- Acclimation period: 18 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21 °C , within protocol limits
- Humidity (%): 40 to 60%, within protocol limits
- Air changes (per hr): no less than 10 air changes per hour
- Photoperiod: 12 hours light/12 hours dark


IN-LIFE DATES:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: 10%
- Type of wrap if used: occlusive wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing



TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
five male and five female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made hourly for the first four hours immediately following dosing, and twice daily for the remainder of the study. Animal body weights were recorded at animal acquisition, day of dosing, and at day 7 and 14 after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy observations
Statistics:
The mean and standard deviation for body weight data was calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Based on lack of mortality and systemic effects
Mortality:
None of the animals died during exposure or post-exposure observation.
Clinical signs:
All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools.
Body weight:
All test animals gained weight over the duration of the study.
Gross pathology:
At necropsy, dermal irritation at the test site was the only abnormal observation.

Any other information on results incl. tables

There were no mortalities and all animals gained weight during the study. Skin irritation occurred at the skin test site. Three out of ten animals had abnormal stools on day one but there were no signs from day three onwards. Apart from skin irritation, there were no other abnormalities noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value for F-133 is greater than 2000 mg/kg under the conditions of this study.
Executive summary:

In an acute dermal toxicity study, groups of young adult New Zealand White rabbits, five males and five females, were dermally exposed to undiluted thermocracked kerosine for 24 hours to 10% of their body surface area at a dose of 2000 mg/kg. Animals were then observed for 14 days.

There were no mortalities and all animals gained weight during the study. All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools. Apart from skin irritation, there were no other abnormalities noted at necropsy. The dermal LD50 was determined to be greater than 2000 mg/kg in both males and females.

This study received a Klimisch score and is classified as reliable without restriction because it was carried out according to EPA OTS 798.1100 and equivalent/similar to OECD TG 434.