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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 21, 1986 - May 16, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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

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:
rat
Strain:
other: CDR (Sprague-Dawley derived)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Species: Albino rats, CDR (Srague-Dawley derived)
- Source: Charles River Breeding Laboratories, Inc; Wilmington , Massachusetts, USA
- Age at study initiation: Young adults /approx. 9-12 weeks
- Weight at study initiation (prefasted): - Males: 250 - 338 g
- Females: 212 - 269 g
- Fasting period before study: approx. 18 h
- Housing: Group housed (6 per cage) during acclimation, individually during study in suspended stainless steel cages with wire mesh bottoms
- Diet: Purina Laboratory Chow, ad libitum
- Water: ad libitum
- Acclimation period: 8, 10 or 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 24.5°C (= 67 - 76°F)
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Test material was administered by oral intubation, using a ball-tipped intubation needle fitted onto a syringe
Doses:
4000 mg/kg, 5000 mg/kg, 6250 mg/kg
No. of animals per sex per dose:
5 (except 5000 mg/kg dose: 10 male, 5 female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1 h, 2 h, and 4 h after application; thereafter daily for 14 days
- Frequency of weighing: Pre-fast, post-fast, day 7 and day 14
- Necropsy of survivors performed: yes
- Gross postmortem examinations were performed on all animals which died or were found dead during the study

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
see table below
Clinical signs:
No abnormalities were observed during 4 h after application.
24 h after application and/or day 2 most animals exhibited hypoactivity, soft stool, fecal and/or urinary staining.
All surviving animals were free of significant abnormalities at termination of the study
Body weight:
Most animals exhibited decreased food consumption at 24 h and/on day 2.
Most animals in the 5000 mg/kg group exhibited weight losses at day 7, but gained weight between day 7 and day 14.
The majority of other animals gained weight between both 7 days and 14 days after dosing.
Gross pathology:
Postmortem examinations of animals found dead during the study revealed primarily changes in lungs and gastrointestinal tract.
Several animals exhibited changes in the stomach and intestine which were suggestive of a corrosive effect.
Other changes appeared to represent autolytic changes or antemortem stress.

Any other information on results incl. tables

Dose levels and mortality (excerpt from original report):

Dose level (mg/kg)

Mortality

Male

Female

Total

Time of death (day)

4000

1/5

1/5

2/10

2 - 3

5000 (A)

(4/5) a

1/5

a

2 – 7

5000 (B)

2/5

-

2/5

2 – 4

6250

2/5

1/5

3/10

2 - 3

a: Because the weight of males dosed initially at 5000 mg/kg [designated 5000 (A)] exceeded the weight range of males dosed at the other two levels, an additional group of males in the same weight range as males in the other two dose levels was dosed [(designated 5000 (B)].

Only data from the 5000 (B) group were considered for estimation of LD50.

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 low toxicity only.