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Toxicological information

Acute Toxicity: dermal

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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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
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.
Body weight:
Three animals lost weight on week two, and one animal lost weight during the 14-day observation period.
Gross pathology:
No gross lesions were observed upon necropsy.

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.