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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001-12-17
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Supplier: Degussa
CAS number: 124-43-6
Name in teh study report: carbamide-peroxide
Purity: not specified
Batch number: 073590600

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks at the time of administration
- Weight at study initiation: Group 1: 188 ± 8.1 g; Group 2: 178.3 ± 3.2 g
- Fasting period before study: yes, overnight
- Housing:
- Diet: ad libitum, starting at 3 hours after dosing
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22.1 °C
- Humidity (%): average 66.1 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/10 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: water is the preferred vehicle according to the OECD TG 423; test substance is water soluble


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


CLASS METHOD
- Rationale for the selection of the starting dose: aqcute toxicity expected to be low
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Statistics:
calculation of means ± SD

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none (0/6 animals)
Clinical signs:
yes, shortly after administration and lasting up tp 6 hours. Fully reversible. Signs of reduced well-being encompasses unspecific alterations, like sedation, apathy, piloerection, hunched posture or closed eyes, in síngle or multiple occurrence.
Body weight:
Animals of both groups gained body weight at 7 or 14 days post treatment.
Gross pathology:
No necropsy findings at termination 14 days after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value is > 2000 mg/kg bw
Executive summary:

The acute oral toxicity of hydrogen peroxide-urea (carbamide peroxide) was determined in the female rat, according to the OECD TG 423 and under GLP conditions. Animals (two groups of 3 rats each) received the test material by oral gavage at 2000 mg/kg bw. Clinical signs were seen during the first 6 hours after dosing. The animals gained body weight after 7 and 14 days post treatment. No mortalities occurred, and there were no necropsy findings at termination on day 14 post treatment. Hence, the oral LD50 is > 2000 mg/kg bw in the rat.

This study is considered to be valid and suitable for assessment.