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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:
1986-1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and valid testing guidance, however limited data on test substance identification were provided. Nevertheless, the study is reliable, relevant and adequate for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No. of animals
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
79/831/EWG, Annex V, Part B
Principles of method if other than guideline:
2-5 animals/sex/dose; Orientation test.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Sulfosuccinat 128 P
- Physical state: White powder
- Analytical purity:>=90%
- 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.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: young
- Weight at study initiation: fasted mean weight 165-201 g
- Fasting period before study: ca. 16 hours before and 3 hours after application
- Housing: 2-5 animals per Makrolon 3 cage, soft wood granulates(ARWI-Center, Essen) as bedding
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324 (Fa. Altromin GmbH, 4937 Lage) ad libitum
- Water (e.g. ad libitum): Public supply, ad libitum
- Acclimation period: 7 or 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20-25°C
- Humidity (%): ca. 45-60%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 25.111986-03.02.1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%, 7.0% and 2.9% (w/v)

MAXIMUM DOSE VOLUME APPLIED: 20 mL/ kg
Doses:
2000mg/kg; 1400 mg/kg; 580 mg/kg
No. of animals per sex per dose:
2 high dose
5 mid dose and low dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms and mortality several times at the day of application, thereafter twice daily. Body weight 1 day before application;before application (fasted) on the day of application; 48 hours, 7 and 14 days after application.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 580 - < 1 400 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 580 - < 1 400 mg/kg bw
Based on:
test mat.
Mortality:
Dose 2000 mg/kg: 2/2 male and 2/2 female animals died 24 hours after application.
Dose 1400 mg/kg: 4/5 male animals died 24 hours after application and 5/5 female animals died 6-24 hours after application.
Dose 580 mg/kg: 0/5 male animals died 14 days after application and 1/5 female died 24hours-14 days after application.
Clinical signs:
Dose 2000 mg/kg:
Piloerection and decreased activity was seen in all male and female animals (4/4) after ca. 1 h.
Piloerection, decreased activity and diarrhea was seen in 2/2 males after ca. 2 h and in 2/2 females after ca. 2-5 h.
Piloerection, decreased activity, diarrhea, squatting attitude and decreased body temperature was seen in 2/2 males after ca. 5 h.
Dose 1400 mg/kg:
5/5 male animals showed moderate piloerection, slightly decreased activity, curved gait, squatting attitude and decreased body temperature after ca.2-3 hours. 5/5 males showed strong piloerection, moderate to marked decreased activity, otherwise unchanged symptoms after ca.3-6 hours.
5/5 female animals showed moderate piloerection, slightly decreased activity, curved gait, squatting attitude and decreased body temperature after ca. 2-3 hours. 4/5 females showed strong piloerection, decreased activity, otherwise unchanged symptoms after ca. 3-6 hours.
Dose 580 mg/kg:
5/5 male animals showed moderate piloerection after ca. 2-4,5 hours. 2/5 males showed diarrhea after ca. 2 hours. 5/5 female animals showed moderate piloerection, moderate curved gait and slightly decreased activity after ca. 2-4,5 hours. 1/5 female showed diarrhea after ca. 2 hours.
Body weight:
See Under Tables below.
Gross pathology:
Dose 2000 mg/kg:
2/2 male animals had a gastro-intestinal tract high-grade filled with liquid, mucosa partially reddish discolored and low-grade emphysema. 2/2 female animals had a bloodily nose and muzzle, otherwise the same symptoms as the males.
Dose 1400 mg/kg:
4/5 males showed strongly reddish discolored medulla, emphysema of the lungs, accumulation of liquid in the thick and small intestine, 1/5 showed no pathological signs. 5/5 female animals showed strongly reddish discolored medulla, emphysema of the lungs, accumulation of liquid in the thick and small intestine, and in addition 1/5 female showed low-grade bleedings in the fundus area.
Dose 580 mg/kg:
The male animals had no special findings. 3/5 females had no special findings. 1/5 female had moderate hydrometra, 1/5 female showed a strongly reddish discolored medulla, emphysema of the lungs and accumulation of liquid in the thick and small intestine.

Any other information on results incl. tables

Males: mean body weights (g) Females: mean body weights (g)

Dose (mg/kg 2000 1400 580 2000 1400 580

-1 day 212 207 209 178 179 181

Start experiment 201 196 197 165 169 171

+ 2 days - 186* 212 - - 175

+ 7 days - 217* 237 - - 178

+ 14 days - 250* 267 - - 186

Body weight gain - 43 58 - - 5

*= value of one survivor

Applicant's summary and conclusion

Interpretation of results:
other: acute harmful
Remarks:
Criteria used for interpretation of results: Off. J. Europ. Comm., L 257, 1983, p.18
Conclusions:
The oral LD50 of the test item containing ≥ 90% active ingredient was <1400 mg/kg >580 mg/kg for male rats
and <1400 mg/kg >580 mg/kg for female rats.
Executive summary:

The acute oral toxicity of test item containing ≥90% act. ingr. was tested by oral gavage in young Wistar rats at dose levels of 580, 1400 and 2000 mg/kg bw. The test compound was administered by single gavage in aqua dest. as solvent and an application volume of 20 mL/kg bw to fasted animals. Two (low and mid dose) or five rats (high dose) were used per sex and dose. Clinical observations and gross macroscopic observations were observed at all dose levels . The LD50was <1400 mg/kg and >580 mg/kg for male rats and <1400 mg/kg and >580 mg/kg for female rats. According to “Off. J. Europ. Commun., L 257, 1983, p. 18”, the test item can be classified as acute harmful.