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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 May - 27 May 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Umwelt Baden-Württemberg, Stuttgart, Germany
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc O,O,O',O'-tetrabutyl bis(phosphorodithioate)
EC Number:
230-257-6
EC Name:
Zinc O,O,O',O'-tetrabutyl bis(phosphorodithioate)
Cas Number:
6990-43-8
Molecular formula:
C16H36O4P2S4Zn (neutral monomer)
IUPAC Name:
zinc bis(O,O-dibutyl dithiophosphate)
Details on test material:
- Name of test material (as cited in study report): Zn-di-n-butyl dithiophosphate
- Physical state: light yellow liquid
- Analytical purity: ca. 92%
- Impurities (identity and concentrations): paraffinic mineral oil, ca. 8%
- Lot/batch No.: 106 92 78
- Expiration date of the lot/batch: June 1992
- Stability under test conditions: stable
- Storage condition of test material: no special storage conditions

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna, Süddeutsche Versuchstierfarm, Tuttlingen, Germany
- Weight at study initiation: 182-198 g (males), 168-186 g (females)
- Housing: individually in Macrolon cages (area 800 cm², height 17 cm)
- Diet: Haltungsdiät "ALMA 0801 H 1003", twice 8 g daily
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for mortality and clinical signs. Body weights were determined prior to study initiation, on the day of oral administration (Day 0), and daily thereafter, except on Days 4, 11 and 12 post-administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: Two rats (one male and one female) were slightly apathetic on the day of application (Day 0) and on Day 1 post-application. The anal region of two other male rats was slightly covered with light brown and pasty excrements on Day 1 post-application. On Day
Gross pathology:
No macroscopical organ changes were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified