White mineral oil (petroleum)

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:

1984-10-29 to 1987-03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

8042-47-5

Cas Number:

8042-47-5

IUPAC Name:

8042-47-5

Constituent 2

Reference substance name:

Highly refined base oil

IUPAC Name:

Highly refined base oil

Test material form:

other: Oily liquid

Details on test material:

- Name of test material (as cited in study report): F-53-01, ARCOprime 400
- Substance type: white mineral oil
- Physical state: transparent, colorless liquid
- Lot/batch No.: 662
- Storage condition of test material: stored in temperature-monitored room (21.1 to 23.9°C)
- Other: Density = 0.8682 g/mL
- Flash Point °F: 450

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, Sandy, Utah
- Age at study initiation: approximately 10 to 12 weeks old
- Weight at study initiation: 1.9 to 3.0 kilograms
- Fasting period before study: not reported
- Housing: individually housed in stainless steel cages with screen floors and a stainless steel pan containing absorbent material
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24.4°C
- Humidity (%): 28 and 62%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1984-10-29 To: 1984 11-27

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abraded area on back
- % coverage: not specified, 4" square gauze covering
- Type of wrap if used: gauze covering was secured with hypoallergenic tape, covered with a dental dam, and secured in place with 3" packaging tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin wiped
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 sex per dose

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 after dosing and twice daily thereafter. Body weights were taken within 24 hours of receipt, just prior to dosing, and at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

No data reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Loose stools was observed on two days during week one, and two of ten animals exhibited slight erythma at site of sample application. No treatment-related lesions were observed.

Gross pathology:

No gross lesions were observed upon necropsy.

Other findings:

Three animals lost weight on week two, and one animal lost weight during the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information LD50 exceeds 2000 mg/kg Criteria used for interpretation of results: EU

Conclusions:

The acute dermal toxicity LD50 of Highly refined base oil to male and female New Zealand White Rabbits is greater than 2000 mg/kg and, therefore, is not classifiable under EU guidelines.

Executive summary:

In an acute dermal toxicity test, Highly refined base oil was applied to the abraded skin of New Zealand White Rabbits (5/sex) at a dose level of 2000 mg/kg under semi-occlusive conditions for 24 hours of exposure. Animals were observed for 14 days after exposure.

No mortality or treatment-related lesions were observed. Three animals lost weight on week two, and one animal lost weight during the 14-day observation period. No gross lesions were observed upon necropsy. The acute dermal toxicity LD50 of Highly refined base oil to male and female New Zealand White Rabbits is greater than 2000 mg/kg and, therefore, is not classifiable under EU guidelines.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable, well-documented study report which meets basic scientific principles.