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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:
1980-11-19 to 1980-12-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no data on test material purity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Solid

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7- 8 weeks old
- Weight at study initiation: males: 148 +/- 8.6 g; females: 151 +/- 6.3 g
- Housing: Housing in groups of 5 in Macrolon cages (type 3)
- Diet: ad libitum rat food, NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: Minimally 4 days
- Fasting period: Overnight

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
(PEG 400)
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg bw
- Source: Fluka AG, Buchs SG, Art. 81170
Prior to study a homogenous suspension was generated by dispersion with an Ultra-Turrax. During treatment suspsension was kept stable with a magnetic stirrer.
Doses:
3000 mg/kg bw (technically maximal achievable dose)
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 weighing: Before study, day 7, and day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and mortality (1, 2, 3, 5 h after application, and daily until to the end of the study (i. e. 14 days))
Statistics:
LD50 values including 95 % confidence limits were calculated by logit model.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities ocurred.
Mortality:
No mortalities occured.
Clinical signs:
- Slight sedation up to 5 h after administration of the test material.
- Slight dyspnoea up to day 6 after administration of the test material.
- Moderate ruffled fur up to 24 h after administration, slight ruffled fur up to day 6 after administration of the test material.
- Slight curved body position up to day 5 after administration of the test material.
The animals recovered within 7 days.
Body weight:
Body weight gain was as expected (At the end of the study: Males 269 +/- 19.1, females 234 +/- 18.3).
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of the test article in rats of both sexes observed over a period of 14 days is greater than 3000 mg/kg body weight.
Executive summary:

In an oral toxicity study similar to OECD guideline 401, five male and five female rats were dosed once with the test article in PEG400 by gastric intubation at a dose level of 3000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortalities were recorded. Slight sedation, slight dyspnoea, slight curved body position and slight to moderate ruffled fur was observed after administration of the test material. The animals recovered within 7 days. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the test article in Wistar rats was established to exceed 3000 mg/kg body weight.