Registration Dossier

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:
1979-09-19 to 1979-10-04
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 434.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
- Name of test material (as cited in study report): API #79-6
- Substance type: petroleum distillation product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 41.7% paraffins, 30.9% cycloparaffins, 27.4% aromatics
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not provided by sponsor
- Storage condition of test material: test material was stored in Elar's test material storage room and removed in 500 mL aliquots for storage in the Toxicology Department clinic.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: adult
- Weight at study initiation: 2.0 to 2.5 kilograms
- Fasting period before study: no
- Housing: individually housed in stainless steel laboratory cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: rabbit's back
- % coverage: 30%
- Type of wrap if used: plastic wrap secured with porous adhesive tape, the entire trunk was wrapped with elastic tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped to remove excess test material
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
- For solids, paste formed: no


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
- Concentration (if solution): no vehicle used
- Lot/batch no. (if required): no vehicle used
- Purity: no vehicle used
Duration of exposure:
24 hours
Doses:
5 mL of undiluted test material
No. of animals per sex per dose:
4 males and 4 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: measured on days 0, 7, and 14
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
none performed
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Remarks on result:
other: approx > 4300 mg/kg bw/day
Mortality:
No rabbits died during the study.
Clinical signs:
During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted.
Body weight:
None of the rabbits lost weight during the testing period.
Gross pathology:
The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for diesel fuel was > 5 mL/kg bw (approx 4300 mg/kg bw).
Executive summary:

In an acute dermal toxicity study, 4 male and 4 female New Zealand white rabbits were shaved 24 hours prior to application of test material. This area constituted 30% of the total body surface area. Afterwards, the animals were returned to their stock cages for 24 hours to allow the skin to heal. On testing day, the exposure sites of four animals (2 males and 2 females) were abraded. Minor abrasions were made through the stratum corneum, but not the dermis. A single dose of 5 mL of undiluted test material per kilogram body weight was applied to gauze sponges backed with plastic wrap to help prevent evaporation of the test material. The sponges and plastic wrap were then taped to the shaved area of the rabbit's backs with adhesive tapes. The entire trunk was wrapped with elastic tape and the rabbits were then returned to their cages. After 24 hours, the bandaging was removed and the skin wiped with gauze sponges to remove excess test material. Animals were observed for mortality, local reactions, and behavioural abnormalities daily for 14 days. Body weights were recorded on days 0, 7, and 14. on day 14 all surviving rabbits were subjected to gross necropsy.

During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted. None of the rabbits lost weight during the testing period. The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related. The test material is classified as practically nontoxic.

This study has a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 434.