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Administrative data

Description of key information

oral: LD 50 > 5000 mg/kg bw (rat)

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
July 1992
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
December 1992
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 4FP90
- Expiration date of the lot/batch: August 1996

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, darkness
Species:
rat
Strain:
Wistar
Remarks:
Shoe:WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH D-16352 Schönwalde
- Weight at study initiation: 131 - 173 g.
- Fasting period before study: 18 h prior dosing
- Housing: transparent polycarbonate cages (macrolone type III, floor area 810 cm2
- Diet: ad libitum, complete rodent diet "Altromin 1314"
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: 7 day

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:
other: sesame oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:
The study was initiated with a sighting study: One female rat was given 2000 mg/kg bw and two days later another rat was given
5000 mg/kg bw. Only slight signs of toxicity were observed in these rats.
On the basis of the results from the sighting study it was decided to carry out the main study with one group consisting of five male and five female rats given a dose of 5000 mg/kg bw. The dose volume administered was 10 mL/kg bw both in sighting and main study.
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Each rat was observed 1, 3 and 6 hours after administration and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
All rats were killed by inhalation of C02 on day 14 and subjected to a gross necropsy examination.
Preliminary study:
The animals included in the sighting study survived the treatment. The rats had a body weight loss on day 14. In animal 1 (2000 mg/kg bw) piloerection was observed 1, 3 and 6 hours after application as well as on days 1 to 4. A pinched abdomen was observed 3 and 6 hours after application. In animal 2 (5000 mg/kg bw) piloerection was observed 1, 3 and 6 hours after application as well as on days 1 to 3. This animal showed a pinched abdomen after 1, 3 and
6 hours and on day 1. The animal was depressed after 3 and 6 hours. The post martern inspection revealed no abnormalities.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None of the animals died after 5000 mg/kg bw in the main study.
Clinical signs:
Four male animals showed a pinched abdomen and piloerection 1, 3 and 6 hours after application. One animal was depressed and had pinched abdomen and piloerection 1 hour after application. This animal showed signs of coma after 3 hours and 6 hours after application laboured respiration was also seen in this animal.
From day 1 up to the end of the observation period all male rats showed normal appearance and behaviour. Exept one animal showed a pinched abdomen and piloerection on day 1 and piloerection only on day 2.
Body weight:
The rats had a normal body weight gain during the study period.
Gross pathology:
The gross necropsy of male and female rats revealed no abnormalities.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
GLP and guideline study (OECD TG 420)

Additional information

Oral

The acute oral toxicity of the test item was determined according to OECD TG 420 (Fixed dose method) and EU Guideline B.1 „Acute toxicity (oral).

The study was initiated with a sighting study, in which one female rat received 2000 mg/kg bw and another rat 5000 mg/kg bw of the test item by gavage. Only slight signs of toxicity were observed in these rats. In the main study, 5 female and male rats received a dose of 5000 mg/kg bw. All animals of the main study survived and showed only slight signs of toxicity. The LD50 of the test item under the experimental conditions described was above 5000 mg/kg bw (Henkel R9600883; 1996).

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. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.