Registration Dossier

Administrative data

Description of key information

For acute oral toxicity the LD50 was determined to be greater than 2000 mg/kg bw in rats (reference 7.2.1 -1).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 28 - Nov 12, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
HsdCpb:WU
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: approx. 6 to 9 weeks
- Weight at study initiation: 169 g (range 165-172 g)
- Fasting period before study: 17 h
- Housing: single, Makrolon cages type III
- Diet: ad libitum
- Water: ad libitum, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-68
- Air changes (per hr): air-conditioned but no rate provided
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
Methocel K4M Premium
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle: 20 mL/kg bw
- Lot/batch no.: ZDP 42/97

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 (m) / 3 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: for 6 h after administration and daily afterwards; weighting: before treatment and on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The body weight data were recorded with the PC-program ,,AKUDAT". The statistical evaluations of the body weight were carried out with PC. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed. All rats survived the observation period.
Clinical signs:
No signs of toxicity were detected in the 3 male and 3 female rats after treatment.
Body weight:
Body weight development of the treated rats was normal.
Gross pathology:
At necropsy no organ alterations were seen.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of this acute oral toxicity study the LD50 is greater than 2000 mg/kg bw.
Executive summary:

The purpose of this acute toxicity study was to provide information on possible health hazards in case of acute oral contact with a test material and serve as a a rational basis for risk assessment to the acute toxicity potential of the test item in man. The test material was tested for acute toxicity in rats. The acute toxic class method was used and 2000 mg/kg bw test item were administered by gavage. Directly before the administration the test material was prepared with aqueous Methocel K4M Premium solution as vehicle. No signs of toxicity were detected in the 3 male and 3 female rats after treatment and no rat died. The gross pathological examination revealed no organ alterations. According to the results of this study the LD50 for the test material was determined to be greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Reliability Score 1 (guideline compliant GLP study).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The purpose of this acute toxicity study was to provide information on possible health hazards in case of acute oral contact with a test material and serve as a rational basis for risk assessment to the acute toxicity potential of the test item in man. The test material was tested for acute toxicity in rats. The acute toxic class method was used and 2000 mg/kg bw test item were administered by gavage. Directly before the administration the test material was prepared with aqueous Methocel K4M Premium solution as vehicle. No signs of toxicity were detected in the 3 male and 3 female rats after treatment and no rat died. The gross pathological examination revealed no organ alterations. According to the results of this study the LD50 for the test material was determined to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item does not require classification for acute toxicity via the oral route according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.