Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SAT 960 405
- Physical state: amber-colourd, viscous liquid
- Lot/batch No.: 070596
- Expiration date of the lot/batch: 09/1997
- Storage condition of test material: room temperture, dark
- Impurities: nonyl phenol < 7%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH
- Weight at study initiation: 136-177 g
- Fasting period before study: 18 hours
- Housing: 2-3 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 3
- Humidity (%): 55 +- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was administered orally by gavage to rats fasted for approximately 18 hours prior to dosing. After dosing diet was withheld for a further 3 hours. Dosing took place between 9.05 and 9.30 a.m.
The study was initiated with a sighting study: One female rat was given the test item in a 2000 mg/kg b.wt. dose. Slight signs of toxicity were observed in this rat.
On the basis of the results from the sighting study it was decided to carry out the main study with one group consisting of five male and five female rats given a dose of 2000 mg/kg b.wt. The dose volume administered was 10 ml/kg b.wt. both in sighting and main study.
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: Each rat was observed 1, 3 and 6 hours after administration and thereafier daily for a period of 14 consecutive days. Body weight (b.wt.) was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,gross pathology
Statistics:
N/A

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2 female rats found dead on day 2
Clinical signs:
pinched abdomen observed in seven rats 1 and/or 3 hours after dosing.
Piloerection in all rats observed until day 2.
Body weight:
Mean body weight increase for males from 165g on day 0 to 236g on day 14.
Mean body weight increase for surviving females from 145g on day 0 to 186g on day 14.
Gross pathology:
One animal showed slight petechail bleeding into the small intestine.
No pathological abnormalities in all other rats, including the two females found dead.
Other findings:
none stated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a study according to OECD Test guideline 420 (acute oral toxicity) under GLP, the rat LD50 of the test substance was determined to be > 2000mg/kg bodyweight. At this dose level, mortality was observed in two of ten animals.
Executive summary:

The acute oral toxicity of the test substance was evaluated in a study according to OECD Test Guideline 420 under GLP.

A limit test with the test substance dose of 2000 mg/kg bodyweight was performed. The substance was applied unchanged by oral gavage to ten Wistar rats of both sexes, which were observed for 14 days post application. Two female rats were found dead on day 2. Body weights gain was not impaired, while no pathological abnormalities were present in all rats, including the two dead females.

Based on these results, the rat oral acute toxicity LD50 of the test substance was > 2000mg/kg bodyweight.