Extracts (petroleum), catalytic reformed light naphtha solvent

Acute Toxicity: dermal

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:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report in general agreement with OECD guideline 402. GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

occlusive dressing used

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

86290-81-5

Cas Number:

86290-81-5

IUPAC Name:

86290-81-5

Constituent 2

Reference substance name:

Premium unleaded gasoline

IUPAC Name:

Premium unleaded gasoline

Test material form:

other: low viscosity liquid hydrocarbon

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Alpine Laboratory Rabbits
- Age at study initiation: Young adult
- Weight at study initiation: 1.9-2.40 kg at time of dosing
- Housing: Individually
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 74 °F
- Humidity (%): 31 - 70% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12 hour, light/dark cycle

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The application site was covered with a 4" square gauze pad which was stabilized with a strip of hypoallergenic tape, after which a dental dam was applied around the back and abdomen and secured in place with a 3" packaging tape. After 24 hours, the wrapping was removed and the skin wiped to remove any test substance still remaining.

Duration of exposure:

24 hrs

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

One application site, approximately 4" square, on the back was selected. The test site was abraded in all rabbits using a sterile 20 guage needle just penetrating the stratum corneum and not the dermis.

The application site was covered with a 4" square gauze pad which was stabilized with a strip of hypoallergenic tape, after which a dental dam was applied around the back and abdomen and secured in place with a 3" packaging tape. After 24 hours, the wrapping was removed and the skin wiped to remove any test substance still remaining.

The test animals were observed for 14 -days after dosing. The animals were observed at hourly intervals for the first 4 hours after dosing. Thereafter, observations were made twice daily for the duration of the study. Observations included: oral discharge, nasal discharge, respiration, tremors, incoordination, recumbancy and stools.

At the end of the 14 days, all surviving animals were sacrificed with CO2. All test animals at dying were submitted to gross necropsy. Gross necropsy was performed under supervision of the study director. The gross necropsy included the observation of salivary glands, thymus, trachea, esophagus, cervical lymph nodes, heart, aorta, kidney, urinary bladder,skeletal muscle, skin, lungs, thyroid glands, adrenal glands, gall bladder, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, pancreas, spleen, testes or ovaries, and liver.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All ten animals survived to termination of the study.

Clinical signs:

other: Dermal irritation that lasted till termination of the study.

Gross pathology:

No visible lesions, with the exception of the dermal effects.

Other findings:

Body weight did not appear to be affected.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for F-64-01 is >2000 mg/kg.  Based on these findings, F-64-01 does not warrant classification as an acute dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The acute toxicity of F-64-01 was evaluated in rabbits via occlusive dermal application at 2000 mg/kg body weight. Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the next 14 days.  No animals died during the observational period.   The surviving animals displayed little or no abnormalities. The surviving animals had no observable abnormalities. The LD50 for F-64-01 is >2000 mg/kg.  Based on these findings, F-64-01 does not warrant classification as an acute dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.