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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:
May - July 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
solid
Specific details on test material used for the study:
Information from study report:
- Name of test material: Emulgator E30, Fest
- CAS number: 5896-54-8
The CAS number in report (5896-54-8) is misleading, since this CAS number does only represent 1-Penta-decanesulfonic acid, sodium salt (1:1), but it is confirmed that the substance used is correctly assigned to CAS 68188-18-1.
- Appearance/Further information: The test substance was supplied as white wax-like leaf-let and was received at the test institute on March 06, 1991.
- Batch No. of test material: 210291
- Purity: 95 %
- Analysis reference: TGL 39237
- Solubility and stability of the test substance in the solvent/vehicle: The substance is known to be stable in water.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation (mean): males 179.1 g ± 15.19 g, females 165.1 g ± 5.59 g
- Housing: 2-3 rats per cage, Makrolon type III cages
- Diet and water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE: Water (Ampuwa, Fresenius, Bad Homburg)

APPLICATION VOLUME: 10 mL/kg bw
Doses:
720, 900, 1000, 1440, 1620, 2000 and 2880 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Range-finding: A dose range-finder was conducted with doses from 57.6 to 2250 mg/kg bw with one male and one female rat per dose group. In the range-finding one female exposed to 2250 mg/kg bw died.
- Duration of observation period following administration: 14 days
- Frequency of observations: Once a day; in addition the animals were observed directly after dosing and also 1 hour after dosing.
- Frequency of weighing: Body weights were determined prestudy, on study day 0 (day of administration), and on study days 2, 9 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: Organs showing macroscopic changes were preserved in neutral - buffered 10 % formalin and were available for histopathological examinations.
Statistics:
The LD50 with the 95 % confidence limits was calculated according to Litchfield and Wilcoxon, J. Pharm. Exper. Therap. 96, 99-113, 1949.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 271 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
1 373 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
1 133 mg/kg bw
Mortality:
Number of deaths in each dose group (time of deaths)
Males: 720 mg/kg 0/5, 900 mg/kg 1/5 (after 7 days), 1000 mg/kg 1/5 (after one night), 1440 mg/kg 1/5 (after one night), 1620 mg/kg 2/5 (after one night up to 7 days), 2000 mg/kg 5/5, 2880 mg/kg (by 28 hours), 5/5 (by 28 hours).
Females: 720 mg/kg 0/5, 900 mg/kg 1/5 (after 7 hours), 1000 mg/kg 3/5 (after one night), 1440 mg/kg 3/5 (after 6 to 48 hours), 1620 mg/kg 5/5 (within 24 hours), 2000 mg/kg 5/5 (by 28 hours), 2880 mg/kg 5/5 (by 28 hours).
Clinical signs:
Non-specific signs of toxicity were observed, including general depression, ruffled fur and dyspnoea. These signs tended to persist longer in the higher dosages where animals survived the investigation period.
Body weight:
No particular specific effect was noted in the body weight data.
Gross pathology:
Gross necropsy observations were also non-specific in animals at termination. Rats which died during the first few days after dosing showed gastrointestinal lesions and some other congested organs. The cause of death of these animals might be related to the intestinal lesions. Histopathology was not performed.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study was conducted according to OECD TG 401 on 5 male and 5 female rats per group receiving each a single dose (gavage administration) of the test substance dissolved in water. Dose groups were 720, 900, 1000, 1440, 1620, 2000 and 2880 mg/kg bw. The animals were observed for signs of intoxication during a 14-days post-exposure period.

Non-specific signs of toxicity were observed, including general depression, ruffled fur and dyspnoea. The signs tended to persist longer in the higher dosages where animals survived the investigation period. Gross necropsy observations were also non-specific in animals at termination. Rats which died during the first few days after dosing showed gastrointestinal lesions and some other congested organs. The cause of death of these animals might be related to the intestinal lesions. Histopathology was not performed.

The LD50 was calculated to be 1271 mg/kg (95 % confidence limit 1104 -1462 mg/kg) for both sexes combined.