Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-cycloalkadiene conc.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report. No restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (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

Details on test material:

- Name of test material (as cited in study report): E000044146
- Colourless liquid; disagreeable odour
- Specific gravity: AP = 0.98 (H2O = 1 at 39.2°F)
- Flash point: AP = 75°F
- Density: 0.9723 g/ml (as determined by UBTL)
- Analytical purity: no data
- Test material data on file with the study sponsor

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Camm Research, Wayne, New Jersey, USA
- Sex: 5 males and 5 females
- Age at study initiation: young adult
- Weight at study initiation: Approximately 2.0 - 3.0 kg
- Housing: Individually, in stainless steel, wire mesh bottom cages
- Diet: Agway rabbit feed ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61 - 70°F
- Humidity: 40 - 60%
- Air changes: At least 10/h
- Photoperiod: 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 6 March 1990 To: 20 March 1990

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal surface
- Type of wrap if used: occlusive (no further details reported)
- Hair clipped approximately 24 hours before dose application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Individual volume adjusted based on density of test material and animal's bodyweight

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: On arrival, the day of dosing, week 1 and at termination
- Clinical observations made hourly for the first 4 hours after dosing, and twice (a.m and p.m.) for the following 13 days
- Necropsy of survivors performed: yes

Statistics:

Not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality and no significant signs of toxicity at only dose tested

Mortality:

None

Clinical signs:

other: All animals showed one or more of the following observations: oedema, erythema, eschar, dried skin at the test site, abnormal faeces.

Gross pathology:

Eight of the ten animals showed one or more of the following observations: oedema, erythema, eschar, dried skin at the test site. The remaining two animals had no gross abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of E000044146 is greater than 2000 mg/Kg.

Executive summary:

The acute dermal toxicity of E000044146 (CAS 68487-10-4) was investigated in groups of 5 male and 5 female rats. A single 24 hour application of 2000 mg/Kg in maize oil (20% w/v at 10 mL/Kg) was applied under an occlusive dressing.

There were no mortalities or significant signs of systemic toxicity and it can be concluded that the LD₅₀ of E000044146 (CAS 68487-10-4) is > 2000 mg/Kg and no classification is warranted under GHS/CLP.