Hydrogen peroxide-urea

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Hydrogen peroxide-urea

EC Number:

204-701-4

EC Name:

Hydrogen peroxide-urea

Cas Number:

124-43-6

Molecular formula:

CH4N2O.H2O2

IUPAC Name:

carbamimidic acid; peroxol

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 or test system 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:

other: 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.

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.