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Administrative data

Description of key information

Acute oral toxicity


OECD 401 (RL1): LD50 > 5000 mg/kg bw, oral, male/female rats


Acute dermal toxicity


A study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (skin irritation, skin sensitisation)

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:
11 Feb - 3 Mar 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
Hoe: WISKf (SPF71)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in-house breeding (Hoechst Aktiengesellschaft, Pharma Forschung, Toxikologie, Germany)
- Weight at study initiation: 186 - 202 g (range)
- Fasting period before study: animals were fasted for 16 h prior to and 2 h after administration
- Housing: group caged in plastic cages, on softwood granulate
- Diet: ALTROMIN 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
Route of administration:
oral: gavage
Vehicle:
other: starch solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality after gavage (no information in the study report on frequency), animals were weighed weekly
- Necropsy of survivors performed: yes
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
2 days after application all animals showed yellow faeces (no information given in the study report about duration).
Body weight:
All animals showed the body weight gain expected for this species and strain during the observation period.
Gross pathology:
No treatment-related findings were identified during the examination.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item was greater than 5000 mg/kg bw after oral administration to rats.
Executive summary:

The acute oral toxicity of the test item was investigated in a group of five male and five female CD rats at a dosage of 5000 mg/kg bw. The animals were starved overnight prior to dosing. The test material was administered at a constant volume-dosage of 20 mL/kg in 0.5% w/v methylcellulose in purified water. 

Mortality and signs of reaction to treatment were recorded during a subsequent 14-day observation period. The animals were killed on the following day and subjected to necropsy. There was no death and sign of reaction to treatment. All animals achieved expected bodyweight gains and necropsy findings were unremarkable. 

Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 5000 mg/kg bw. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 mg/kg bw
Quality of whole database:
OECD Guideline study under GLP conditions

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

Justification for classification or non-classification

Based on the data provided, the test item is not classified for acute oral/dermal toxicity according to Regulation (EC) No 1272/2008.

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