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Toxicological information

Toxicity to reproduction: other studies

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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:
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:
other: EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.