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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Read Across to Lubricant Base Oils
- Test substance: API 83-12 (CAS No. 64742-53-6)
- Name of test material (as cited in study report): API 83-12
- Substance Type: Lubricant Base Oils (IP 346 ≥ 3%)
- Molecular weight (if other than submission substance): 148.3
- Physical state: clear, colorless liquid
- Composition of test material, percentage of components: 61.6% saturates, 36.1% aromatics, 2.3% polar compounds
- Viscosity: 53.5 SSU at 100°F, 33.3 SSU at 210°F
- Sulphur, Wt%: 0.019
- Gravity API: 26.2
- Flash Point 255°F
- Distillation at 10% 533, at 95% 713 °F
- Initial Boiling Point: 464°F
- End Point 796 °F
- Pour Point 60°F
- Colour 0.5
- Aniline 148.3 °F

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adults (approximately 14 weeks of age)
- Weight at study initiation: weight ranged between 2,500 and 2,935 grams
- Housing: animals were housed in individual screen-bottom cages in temperature and humidity controlled rooms
- Diet: Purina Certified Rabbit Chow was provided ad libitum
- Water: water was provided ad libitum
- Acclimation period: fourteen days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24 °C
- Humidity (%): 60-78%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1984-09-05 To: 1984-10-10

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: hair was removed from the back of each animal
- % coverage: the shaved area constituted approximately 10% of the total body surface area
- Type of wrap if used: occlusive, wrapped with an eight-ply gauze bandage and overwrapped with Saran Wrap and Elastoplast tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): upon removal exposure site was wiped clean with wet disposable towels (not washed)
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg
- Constant volume or concentration used: yes



VEHICLE
-No vehicle
Duration of exposure:
24 hours
Doses:
2000 or 5000 mg/kg
No. of animals per sex per dose:
4/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rabbits were observed for clinical signs and mortality hourly for the first six hours after dosing, then daily for dermal irritation and twice daily for clinical signs and mortality for a period of fourteen days. Body weights were take immediately prior to test article administration and at days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and gross necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
Skin irritation and the occurrence of soft stool occurred in some animals, but this latter effect was transient. Skin irritation ranged from slight to severe for erythema and oedema; slight to marked for atonia, desquamation, and fissuring; and from slight to moderate for coriaceousness.
Body weight:
Body weights were recorded prior to administration of test material and then 7 and 14 days post- administration

Any other information on results incl. tables

There were no deaths during the study. The only clinical observation with the exception of skin irritation was soft stool in all animals. This was observed 3 hours after dosing and returned to normal by day 2. Skin irritation was observed in all animals and ranged from slight to severe for erythema and oedema, from slight to marked for atonia, desquamation and fissuring and from slight to moderate for coriaceousness. Other dermal irritation seen included blanching and subcutaneous hemorrhage. All animals had gained weight by the end of the study. At necropsy, except for the skin lesions no other visible lesions were recorded.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was found to be greater than 2000 mg/kg of body weight for both male and female rabbits
Executive summary:

Read across justification

The physical and chemical properties of foots oils are comparable to the other lubricant base oil intermediate streams from which they are derived. Hence their health effects are also similar to those of other lubricant base oils, and the conclusions of the hazard assessment for other lubricant base oils also apply to foots oils.

In an acute dermal toxicity study, groups of New Zealand white rabbits (four male and four female) were dermally exposed to lubricant base oil API 83 -12 for 24 hours at doses of 2000 mg/kg bw.  Animals then were observed for 14 days.

 

After 14 days all animals were killed and were subjected to a gross necropsy. There were no mortalities in any of the studies. The only clinical signs were skin irritation and the occurrence of soft stool in some animals, but this latter effect was transient. Skin irritation ranged from slight to severe for erythema and oedema; slight to marked for atonia, desquamation, and fissuring; and from slight to moderate for coriaceousness. The LD50s were greater than the doses that had been applied (i.e.2000 mg/kg)

 

This study received a Klimisch score of 1 and is classified as reliable without restriction.