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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 August 2009 - 11 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
The temperature recorded in the animal room was sometimes outside of the target ranges specified in the study. plan,.
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
The temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Post crystallization of ammonium sulphate aqueous phase products resulting from ammoniac neutralisation of sulphuric acid waste waters formed during methylmethacrylate synthesis
IUPAC Name:
Post crystallization of ammonium sulphate aqueous phase products resulting from ammoniac neutralisation of sulphuric acid waste waters formed during methylmethacrylate synthesis
Details on test material:
- Physical state: brown black liquid
- Lot/batch No.: 01/07/09
- Expiration date of the lot/batch: 01/07/2011
- Storage conditions of test material: at room temperature
- Purity/Impurities: not applicable (complex composition)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks old
- Weight at study initiation: 200 +/- 10 g
- Fasting period before study: 18 hours
- Housing: polycarbonate cages with stainless steel lid
- Diet (e.g. ad libitum): SSNIFF R/M-H pelleted maintenance diet
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

IN-LIFE DATES: From: 13 August 2009 To: 15 September 2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
purified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/kg
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: standard vehicle used for specific routes of administration

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to information available on the test item, for animal welfare reasons, the starting
dose-level of 300 mg/kg was chosen.
Doses:
300 and 2000 mg/kg.
No. of animals per sex per dose:
3 females per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: a period of up to 14 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Type, time of onset and duration of clinical signs were recorded for each animal individually.
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
Neither mortality nor clinical signs were observed during the study.
Clinical signs:
Neither mortality nor clinical signs were observed during the study.
Body weight:
When compared to CIT historical control animals, the body weight gain of the animals was not affected by treatment with the test item.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD0 of the test item was higher than 2000 mg/kg in rats.
Executive summary:

The acute oral toxicity of the test item was evaluated in rats according to OECD(No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The test item was prepared in purified water and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of three fasted female Sprague-Dawley rats.

The study design was as follows:

 

Dose-level

(mg/kg)

Volume

(mL/kg)

Female

300

10

3

2000

10

3

2000

10

3

 

Treatment was first performed at the dose-level of 300 mg/kg. As no death occurred, a second group was treated at the dose-level of 2000 mg/kg. A third group was also treated at the same dose‑level to confirm the absence of mortality at this dose-level.

 

Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy.

 

Neither mortality nor clinical signs were observed during the study. When compared to CIT historical control animals, the body weight gain of the animals was not affected by treatment with the test item. At necropsy, no apparent abnormalities were observed in any animal.

The oral LD0of the test item was higher than 2000 mg/kg in rats.

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