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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FIFRA (US EPA)
Qualifier:
according to guideline
Guideline:
other: TSCA (US EPA)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
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 10 to day 14.
Body weight:
Some animals with decreased food consumption from day 3 to day 7.
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.