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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: 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.