Solvent naphtha (petroleum), medium aliph.

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Thermocracked kerosine (CAS# 68333-23-3)

IUPAC Name:

Thermocracked kerosine (CAS# 68333-23-3)

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 or test system 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.