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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
[2-(1-ethoxyethoxy)ethyl]benzene
EC Number:
219-868-9
EC Name:
[2-(1-ethoxyethoxy)ethyl]benzene
Cas Number:
2556-10-7
Molecular formula:
C12H18O2
IUPAC Name:
[2-(1-ethoxyethoxy)ethyl]benzene

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities.
Clinical signs:
none
Body weight:
none
Gross pathology:
none

Applicant's summary and conclusion

Interpretation of results:
other: Not acute toxic
Remarks:
Based on EU CLP criteria (EC 1272/2008 and its updates)
Conclusions:
The acute oral LD50 of Hyacinth body for rats was >5000 mg/kg bw. Based on the results of this study it is concluded that Hyacinth body is not acute orally toxic.
Executive summary:

An acute oral toxicity study with Hyacinth body was performed according to a method similar to OECD TG 401, and was rated Klimisch 2 as it was performed comparable to guideline study with acceptable restrictions and it was pre-GLP. In this study, 10 rats were administered Hyacinth body at dose level 5000 mg/kg bw. None of the animals died. The acute oral LD50 for rats was therefore set at >5000 mg/kg bw.

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