Distillates (petroleum), light thermal cracked, debutanized arom.

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other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting but otherwise adequate for assessment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 (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Naphtha (petroleum), steam-cracked middle arom.

EC Number:

271-138-9

EC Name:

Naphtha (petroleum), steam-cracked middle arom.

Cas Number:

68516-20-1

IUPAC Name:

68516-20-1

Constituent 2

Reference substance name:

E000144700

IUPAC Name:

E000144700

Details on test material:

- Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F

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 food ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61-70°F
- Humidity: 40-60%
- Air changes: At least 10/hour
- 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 (size of application area not reported)
- Type of wrap if used: Occlusive (no further details reported)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes (Individual dose volumes were adjusted based on the density (0.9145 g/mL) and the 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 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality or evidence of systemic toxicity at only dose tested

Mortality:

No mortalities.

Clinical signs:

All animals on study exhibited one or more of following: oedema, erythema, eschar and dried skin at test site, abnormal stools.

Body weight:

All animals gained weight during the study.

Gross pathology:

All animals exhibited one or more of following: oedema, erythema, eschar and dried skin at test site.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 for E000144700 is greater than 2000 mg/kg.

Executive summary:

The acute dermal toxicity of E000144700 (CAS 68516-20-1) was assessed in a group of 5 male and 5 female albino rabbits. The test substance was applied at 2000 mg/kg under an occlusive dressing for 24 hours. None of the animals died and there were no significant signs of systemic toxicity.

The acute dermal LD50 for E000144700 (CAS 68516-20-1) is greater than 2000 mg/kg and no classification is warranted under Dir 67/548/EEC or under GHS/CLP.