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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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and valid methods. Although some details were missing, the the study is considered relevant, adequate and reliable for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Netzer SB 10, sulfobernsteinsäureester-Natriumsalz, Di-isodecylsulfobernsteinsäureester-mono-natriumsalz
- Physical state: Almost colorless, clear liquid
- Analytical purity: 63.0-67.0%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: E06 124 505 (produced 1988-07-03)
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: In the dark, at 22°C

Test animals

Species:
rat
Strain:
other: Wistar Hoe:WISKf (SPF71)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, SPF
- Age at study initiation: Males ca. 7 weeks; Females ca. 8 weeks
- Weight at study initiation: 158 g mean weight males; 154 g mean weight females
- Fasting period before study: Ca. 16 hours before and 3-4 hours after application
- Housing: In groups of 5 animals, in Makrolon cages (Type 4) on softwood pellets
- Diet (e.g. ad libitum): Rattendiät Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: deionised water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations after 10, 30 minutes, 1, 2, 4, 6 hours and then daily; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 260 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality observed.
Clinical signs:
On the day of application the animals showed nonspecific signs of toxicity. The female animals showed in addition adverse effects of the movement sequence, respiration and diarrhea. From the second day post application all the symptoms were reversible.
Body weight:
There were no adverse effects on the bodyweight gain.
Gross pathology:
No gross pathology was observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item in male and female Wistar rats is > 2000 mg/kg bw. The test item does not require labeling according to the classification criteria of Directive 83/467/EEC and the Hazardous Substances Regulation.
Executive summary:

Acute oral toxicity of a formulation containing 36 -67% active ingredient was tested in 10 Wistar rats (5 males and 5 females) by oral gavage of the test item in deionised water at a dose of 2000 mg/kg bw. No mortality was observed. On the day of application the animals showed nonspecific signs of toxicity. The female animals showed in addition adverse effects of the movement sequence, respiration and diarrhea. From the second day post application all the symptoms were reversible. There were no adverse effects on the bodyweight gain. No gross pathology of the euthanized animals was observed. The LD50 in male and female Wistar rats is > 2000 mg/kg bw (test material) or > 1260 mg/kg bw (active ingredient).