Diisopropylamine

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Diisopropylamine

EC Number:

203-558-5

EC Name:

Diisopropylamine

Cas Number:

108-18-9

Molecular formula:

C6H15N

IUPAC Name:

bis(propan-2-yl)amine

Details on test material:

- Name of test material (as cited in study report): diisopropylamine
- Physical state: liquid
- Analytical purity: 99.61%
- Purity test date: 1991-02-15
- Lot/batch No.: F9010
- Expiration date of the lot/batch: 1year (until march 1992)
- Stability under test conditions: 2hours
- Storage condition of test material: stable under standard conditions
- Other: origin: La Chambre

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles river France (Saint Aubin lès Elbeuf, 76410 Cléon, France)
- Age at study initiation: 7 weeks
- Weight at study initiation: 250g (males) and 200g (females)
- Fasting period before study: no
- Housing: individually inwire mesh bottomed, stainless steel cages (Iffa Crédo, 69210 l'Arbresle, France): 369cm²x18cm
- Diet (e.g. ad libitum): ad libitumA 04 C (U.A.R., Villemoisson, 91360 Epinay sur Orge, France)
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 40-70
- Air changes (per hr): approx. 10-11
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10-Apr-1991 (Arrival) To: 29-May-1991 (Necropsy)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Stability of the test compound under the conditions of administration was determined prior to the initiation of the study. The identity and concentration of the compound in the vehicle were verified once while the study was in progress.

Duration of treatment / exposure:

33 days

Frequency of treatment:

7 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
15, 50 and 150 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose:

15

Control animals:

yes, concurrent vehicle

Details on study design:

- Dose selection rationale: range-finding study n° DDO 432

Statistics:

1-way analysis, pair wise comparisons of variance (Snedecor) and student t-test

Results and discussion

Effect levels

Dose descriptor:

NOEL

Effect level:

>= 150 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: No histological effects on the reproductive organs

Observed effects

See section 7.5.1

Applicant's summary and conclusion

Executive summary:

The histological effects of Diisopropylamine (DIPA) on the reproductive organs of male and female rats were evaluated in a repeated oral toxicity performed according to OECD N°407 guideline (Repeated Dose 28-Day Oral Toxicity in Rodents).DIPA was administered orally once daily to Sprague Dawley rats for 4 weeks at doses of 0, 15, 50, and 150 mg/kg/d. No effects were observed on mammary tissue, uterine cervix, ovaries, uterine tubes, vagina, prostate, testes, seminal vesicles and epididymides.