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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:
1980-10-30 to 1980-11-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to OECD Guideline 402.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

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): API 78-9 Solvent dewaxed light paraffinic oil
- CAS number: 64742-56-9
- API Identification number: API 78-9

Molecular weight (if other than submission substance): 322
- Substance type: Other Lubricant Base Oil (Sufficiently Refined, IP 346 < 3%)
- Physical state: Liquid
- Analytical purity: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Stable at room temperature
- Other:
Specific gravity 60/60: 0.8490
API gravity: 35.2
Viscosity CS: 11.5 @ 100°F
Viscosity CS: 2.81 @ 210°F
Viscosity SUS: 64.2 @ 100°F
Viscosity SUS: 35.6 @ 210°F
Viscosity Index: 97
Viscosity-gravity constant: 0.807
Pour Point: -3°F
Aniline Point: 200.5 °F
Ramsbottom Carbon:0.03%
Density 20C: 0.8453
Refractive Index ND20:1.4675
UV Absorptivity, 260 nm: 0.500
UV Absorptivity, 290 nm: 0.261
UV Absorptivity, 343 nm: 0.002
Distillation range (°F) 597-751 (5 and 95%)
Initial Boiling Point (°F): 536
Final Boiling Point (°F): 782


- Composition of test material:
ASTMD-2007, Wt. %:
Asphaltenes: 0.0
Saturates: 88.7
Aromatics 11.3
Polar compounds: 0.0

Carbon Distribution (ndm)
% Aromatic carbons: 3
% Naphthenic carbons: 30
% Paraffinic carbons: 67

Sulfur, ppm: 490
Basic Nitrogen, ppm: 20
Total Nitrogen, ppm: 237

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elkhorn Rabbitry (Watsonville, California)
- Age at study initiation: Not reported
- Weight at study initiation: 2.4 - 3.2 Kg
- Fasting period before study: Not reported
- Housing: Individual cage
- Diet (e.g. ad libitum): Purina Rabbit Chow® ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported


IN-LIFE DATES: From: 1980-10-16 To: 1980-11-13

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: stomach
- % coverage: 30%
- Type of wrap if used: Plastic wrap taped with porous adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): With guaze sponges
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg (5 g/kg)
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
5000 mg/kg (5 g/kg)
No. of animals per sex per dose:
4/sex/dose
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behavioral - Day 0, and 2/day till Day 14; Mortality and local reactions - 2/day till Day 14; Body weight - Day 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed in male or female rabbits dosed with API 78-9 at 5000 mg/kg.
Clinical signs:
No visible signs of clinical toxicity were observed in male and female rabbits dosed with API 78-9 at 5000 mg/kg
Body weight:
Body weights of all male and female rabbits in the test and control groups appeared normal througout the study period.
Gross pathology:
No lesions attributable to test material administration were observed throughout the study period and 14-day post exposure observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal administration of API 78-9 at 5000 mg/kg did not result in any dermal irritation or signs of clinical toxicity. Gross necroscopy did not reveal any signs of systemic toxicity at the 5000 mg/kg dose level.

The acute dermal LD50 for API 78-9 is >5000 mg/kg.
Executive summary:

In an acute dermal toxicity study, API 78-9 was administered to 4 New Zealand White rabbits/sex at a dose of 5000 mg/kg for 24 hours. Prior to application of the test material the exposure sites of four rabbits were abraded by making epidermal incisions. The remaining four rabbits were left unbraded. Another group of eight (4/sex) rabbits were used as control animals.

Behavioral reactions were monitored through the 24 -hour contact period. Mortality, clinical signs of toxicity, and behavioral abnormalities were observed for twice daily through the 14 -daypost exposure observation period. Body weight was recorded for all animals on Day 0, 7, and 14 of the study period. On Day 14 all animals were necropsied and observed for gross pathological changes.

Dermal administration of API 78-9 at 5000 mg/kg did not result in any dermal irritation or signs of clinical toxicity. Gross necroscopy did not reveal any signs of systemic toxicity at the 5000 mg/kg dose level.

The acute dermal LD50 for API 78-9 is >5000 mg/kg

This study is classified as reliable without restriction because it was conducted according to OECD guideline 402.