Diisopropylbiphenyl and triisopropylbiphenyl

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 27, 1986 - Feb 26, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FIFRA (US EPA)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: TSCA (US EPA)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diisopropylbiphenyl and triisopropylbiphenyl

EC Number:

915-589-8

Molecular formula:

not applicable for UVCB substance

IUPAC Name:

Diisopropylbiphenyl and triisopropylbiphenyl

Details on test material:

- Name of test material (as cited in study report): Diisopropyl biphenyl, isomeric mixture (acronym used: DIPB or di-IPB/tri-IPB)
- Substance type: organic
- Density: 0.9669 g/ml
- Physical state: clear liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Isomers composition: no data
- Lot/batch No.: NBP-3184823
- Expiration date of the lot/batch: no data
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species: New Zealand White, albino rabbits
- Source: Hazleton-Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: young adult (at least 8 weeks)
- Weight at study initiation: - Males: 2.4 - 2.8 kg
- Females: 2.6 - 2.8 kg
- Housing: individually in suspended stainless steel cages with wire mesh bottoms
- Diet: Lab Rabbit Chow HF, ad libitum:
- Water: ad libitum
- Acclimation period: 16 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 16°C - 21°C (60 - 70°F)
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped intact skin of the dorsal area of the trunk
- Application: directly onto the skin and spread evenly over the entire area
- Type of wrap if used: Gauze, impervious plastic sleeve secured by Elizabethan collars


REMOVAL OF TEST SUBSTANCE
Following 24 h of exposure, wrappings were removed and test sites wiped free of excess test material

TEST MATERIAL
- Amount applied: 5.2 ml/kg
- Concentration: undiluted

Duration of exposure:

24 h

Doses:

single dose (5.2 ml/kg = ca. 5000 mg/kg)

No. of animals per sex per dose:

5 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2, and 4 h after application and daily thereafter for 14 days
- Frequency of weighing: Pre-test (at the time of clipping), pre-dose (for calculation of doses), day 7 and day 14
- Necropsy of survivors performed: yes
- Necropsy observations: Lung, ovaries, uterus

Statistics:

not appicable (limit test)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived throughout the study.

Clinical signs:

other: Few (female) animals exhibited severe dermal effects at the dose site (necrosis followed by eschar formation, fissuring and/or exfoliation of the eschar tissue) between day 3 and day 9 (see table below). All animals were free of abnormal signs from day 1

Gross pathology:

Gross postmortem observations were similar to those seen in control animals or represent normal physiological variation.

Any other information on results incl. tables

Summary of pharmacologic and toxicologic signs (excerpt from orignal report)

	Day					1	2	3	4	5	6	7	8	9	10	11	12	13	14
	Hr	1	2	3	4	24
		M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F
Observation
Food consumption decrease	-	-	-	-	-	-	-	2/2	2/3	1/1	1/2	2/1	-	-	-	-	-	1/-	-
Necrosis	-	-	-	-	-	-	-	-/2	-/2	-/2	-/2	-/2	-/1	-	-	-	-	-	-
Eschar	-	-	-	-	-	-	-	-	-	-/2	-/2	-/2	-/1	-	-	-	-	-	-
Exfoliation	-	-	-	-	-	-	-	-	-	-	-/1	-/2	-/2	-/1	-	-	-	-	-
Fissuring	-	-	-	-	-	-	-	-/1	-/2	-/2	-/2	-	-	-	-	-	-	-	-

M: male, F: female

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

The test substance, alkylation and transalkylation products of biphenyl with propene showed no systemic toxicity after dermal exposure to rabbits.