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Administrative data

Description of key information

The acute oral LD50 was determined to be > 2000 mg/kg b.w. in rats.

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:
2003-07-21 to 2003-08-07
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)
Version / remarks:
2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Shoe:WIST
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 140 - 160 g b. w
- Housing: 2-3 per cage, macrolone type III, floor area 810 cm2
- Diet: ad libitum, Altromin 1314 from Altromin, D-32791 Lage, Lippe
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w.
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation: 30 min, 2, 4 and 6 h after application and daily for 14 days; weighing: body weight was recorded on day 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
No data provided
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Hunched posture and piloerection for up to 6 h after treatment.
Body weight:
A normal body weight gain was observed.
Gross pathology:
No pathological abnormalities were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 in this study with rats was determined to be > 2000 mg/kg b.w..
Executive summary:

An acute oral toxicity using the class method according to OECD 423 was conducted. 2000 mg/kg b.w. of the test substance were administered to 6 female rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. The test substance produced slight signs of toxicity like a hunched posture and piloerection for up to 6 h after treatment. No mortality was observed and the animals showed a normal body weight gain during the study. Therefore the acute oral LD50 in this study was determined to be > 2000 mg/kg b.w. in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The available study is sufficient for assessment.

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

Acute toxicity: Oral route

An acute oral toxicity using the class method according to OECD 423 was conducted. 2000 mg/kg b.w. of the test substance were administered to 6 female rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. The test substance produced slight signs of toxicity like a hunched posture and piloerection for up to 6 h after treatment. No mortality was observed and the animals showed a normal body weight gain during the study. Due to these results the test substance was considered to be practically nontoxic and the oral LD50 > 2000 mg/kg b.w. was derived for rats.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity via oral route, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.