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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Principles of method if other than guideline:
other: combined repeated dose and reproduction / developmental screening
GLP compliance:
Limit test:

Test material

Constituent 1
Reference substance name:
Triple Superphosphate (TSP)
Triple Superphosphate (TSP)
Test material form:
other: granules
Details on test material:
- Name of test material (as cited in study report): Granular Triple Superphosphate (GTSP)
- Substance type: Light brown to black granules
- Physical state: Solid
- Analytical purity: Treated as 100% pure
- Purity test date: Not indicated
- Lot/batch No.: ERC 20.12.2001/02
- Expiration date of the lot/batch: Not indicated.
- Stability under test conditions: Not indicated.
- Storage condition of test material: Room temperature (test formulations in the freezer, -20°C)
- Composition of test material, percentage of components: tested batched contained 45.43% P2O5 equivalent

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River (UK) Limited, Margate, Kent, England.
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 297 to 365 g for males and 194 to 251 g for females
- Fasting period before study: not applicable
- Housing:Unless paired for mating, the animals were singly housed in RB3 modified cages consisiting of high density polypropylene bodies with lids and floors of stainless steel grid. These cages were suspended in batteries over trays lined with absorbent paper. RB3 modified cages were used
throughout the study with the exception of reproductive subgroup females from Day 17 after mating, where RB3 solid-bottomed cages were used.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 days

- Temperature (°C): 19-23°C
- Humidity (%): 40-70%, , on one occasion during the acclimatization period relative humidity was recorded as 20% and was re-established within
24 hours.
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 December 2001 To: 19 February 2002

Administration / exposure

Route of administration:
oral: gavage
Details on exposure:
The formulation for Group 4 (150 mg/mL) was mixed by adding the required volume of vehicle (water purified by reverse osmosis) to the required
weight of GTSP and magnetically stirring for up to 1 hour until a visibly homogenous brown suspension was formed. Formulation for Groups 3 and 2
were prepared by direct dilution of this suspension.

- Concentration in vehicle: 25 - 75 - 150 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
Details on analytical verification of doses or concentrations:
See Section 7.8.1.
Details on mating procedure:
See Section 7.8.1.
Duration of treatment / exposure:
See Section 7.8.1.
Frequency of treatment:
See Section 7.8.1.
Duration of test:
See Section 7.8.1.
No. of animals per sex per dose:
See Section 7.8.1.
Control animals:
yes, concurrent vehicle
Details on study design:
See Section 7.8.1.


Maternal examinations:
See Section 7.8.1.
Ovaries and uterine content:
See Section 7.8.1.
Fetal examinations:
See Section 7.8.1.
See Section 7.8.1.
See Section 7.8.1.
Historical control data:
See Section 7.8.1.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects. Remark: See Section 7.8.1.

Details on maternal toxic effects:
See Section 7.8.1.

Effect levels (maternal animals)

Dose descriptor:
Effect level:
750 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: other:

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects. Remark: See Section 7.8.1.

Details on embryotoxic / teratogenic effects:
See Section 7.8.1.

Effect levels (fetuses)

Dose descriptor:
Effect level:
750 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: a slightly lower group mean offspring body weight of both sexes at 1500 mg/kg/day on Day 1 through to Day 4 and a possible in-utero growth retardation

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

See Section 7.8.1.

Applicant's summary and conclusion

NOAEL: 750 mg/kg/day for reproduction/developmental toxicity based on body weights of offspring.
NOAEL(systemic) = 250 mg/kg bw/d for general toxicity based on haematological and clinical parameters and horizontal bands on incisors
NOAEL (local) <250 mg/kg bw/d for general toxicity based on irritating effects in the stomach