Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline under GLP. Assessment supported with ToxRTool (Schneider, K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10:189(2):138-44)

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
Details on test material:
Name of test material (as cited in study report): SAT 950 733 (CAS-No.: 59344-62-6)
This wrong CAS-No. of the test substance in the report R9700033 was not correct.
It should be:
89% OXM Ethanone, 1-(2-hydroxy-5-tert-nonylphenyl)-
11% tert-Nonylphenol
- Physical state: amber-coloured, vicous liquid
- Analytical purity: 89%
- Impurities (identity and concentrations): 11% Nonylphenol
- Expiration date of the lot/batch: 07.1999

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: 146-173 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:
other: sesame oil
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 9.30 and 10.00 a.m.
The study was initiated with a sighting study:
One female rat SAT 960 824 was given 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 b.w.
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 thereafter daily for aperiod
of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
Statistics:
N/A

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
Males
After 1 hour all animals showed diarrhoe, decreased motor activity and piloerection. After 3 and 6 hours decreased motor activity and piloerection were seen in all animals. On day 1 only piloerection was observed. From day 2 until the end of observation period no abnormalities were seen.
Females
After 1 hour all animals showed diarrhoe, decreased motor activity and piloerection. After 3 and 6 hours decreased motor activity and piloerection were seen in all animals. On days 1 and 2 only piloerection was observed. From day 3 until the end of observation period no abnormalities were seen.
Body weight:
The rats had a normal body weight gain during the study period.
Gross pathology:
The gross necropsy of male and female rats revealed no pathological abnormalities.
Other findings:
none stated

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 and is therefore considered to be practically nontoxic.
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 with the vehicle sesame oil by oral gavage to five Wistar rats of both sexes, which were observed for 14 days post application. No mortality occured. Body weights gain was not impaired, while no pathological abnormalities were found. Clinical signs like diarrhoea, pilorection or decreased motor acitivity was observed maximally until day 2. Based on these results, the rat oral acute toxicity LD50 of the test substance was > 2000mg/kg bodyweight. Therefore, the test substance is considered practically non-toxic.