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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:
07.03.1994 - 24.03.1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) maleate
EC Number:
205-524-5
EC Name:
Bis(2-ethylhexyl) maleate
Cas Number:
142-16-5
Molecular formula:
C20H36O4
IUPAC Name:
1,4-bis(2-ethylhexyl) (2Z)-but-2-enedioate
Constituent 2
Chemical structure
Reference substance name:
Dioctyl maleate
EC Number:
220-835-6
EC Name:
Dioctyl maleate
Cas Number:
2915-53-9
Molecular formula:
C20H36O4
IUPAC Name:
dioctyl but-2-enedioate
Details on test material:
- Name of test material (as cited in study report): Dioctylmaleinat (DOM)
- Chemical name (as cited in study report): (Z)-2-Butendisäure-bis-(2ethylhexyl)ester
- Substance type: active substance
- Physical state: colorless-yellowish liquid
- Analytical purity: 96.1%
- Lot/batch No.: Ch 35559, Beh. 828
- Expiration date of the lot/batch: August 1994 at the earliest
- Stability under test conditions: stable for at least one year
- Storage condition of test material: in a tightly closed vessel in the flue to the exclusion of atmospheric oxygen
- pH: neutral
- Homogeneity: The liquid seems optically to be homogeneous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adults
- Weight at study initiation: mean weight male rats 158g, mean weight female rats 133.6 g
- Fasting period before study: 16 hours
- Housing: conventional housing in Makrolon cages type III
- Diet: Ssniff r 10 Alleindiät für Ratten ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): artificial light, 12 hours light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.13 cm³/kg bw
Doses:
2000 mg/kg BW
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were conducted 30 min, 1 hour, 2, 3, 4, 5, and 6 hours post application, followed by a daily observation during the two weeks post application period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and pathological organ changes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
Not observed
Body weight:
No significant effects on body weight were observed
Gross pathology:
A significant dilatation of the right renal pelvis was observed in one animal, but this was considered not to be a substance-related effect as it is unlikely that this effects already occurs after two weeks. Also, this effect is often heritable.
Other findings:
not reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of dioctyl maleate to rats was > 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study (limit test) one group of fasted, adult Wistar rats (5/sex) were given a single oral dose of dioctyl maleate at a dose level of 2000 mg/kg bw and observed for 14 days. The oral LD50 males was determined to be > 2000 mg/kg bw (limit test), oral LD50 females > 2000 mg/kg bw (limit test), oral LD50 combined > 2000 mg/kg bw (limit test). No mortalities occurred and no clinical signs were observed during the observation period. Dioctyl maleate is of low toxicity. Based on the results of the present test, dioctyl maleate does not require labeling.