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:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
17 December 2001
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Form: pale yellow liquid
Specific details on test material used for the study:
Sponsor's identification : HMPPB
Description : pale yellow liquid
Storage conditions : room temperature in the dark

Test animals

Species:
rat
Strain:
other: HsdRccHan: WIST
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Females: nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks-old
- Weight at study initiation: 150-173 g
- Fasting period before study: overnight before dosing
- Housing: in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access with exception of an overnight fast immediately before dosing and for approximatively 3 to 4 hours after dosing (2014 Taklad Global Rodent diet supplied by Harlan Laboratories UL Ltd., Oxon, UK)
- Water (e.g. ad libitum): free access with exception of an overnight fast immediately before dosing and for approximatively 3 to 4 hours after dosing
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: none
- Concentration in vehicle:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: max dose of 2000 mg/kg bw
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: clinical observatiobs (0.5; 1; 2 and 4h after dosing and subsequently once daily for 14 days); weighing (days 0; 7 and 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
Hunched posture was noted in 1 animal 4h after dosing
Body weight:
All animals showed expected gains in bw over the observation period
Gross pathology:
No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity of test material in the female Wistar rat was estimated to be >2000 mg/kg bw in acute oral toxicity test performed according to OECD TG 420 and GLP.
Executive summary:

The acute oral toxicity of test material in the female Wistar rat was estimated to be >2000 mg/kg bw in acute oral toxicity test performed according to OECD TG 420 and GLP.