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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD) (test substance purity not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
, adopted 24 Feb 1987
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
, adopted 31 July 1992
GLP compliance:
yes (incl. QA statement)
Remarks:
ToxLabs Prüflabor GmbH
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)
EC Number:
308-219-6
EC Name:
Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)
Cas Number:
97926-05-1
IUPAC Name:
97926-05-1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT 970397
- Physical state: colorless liquid
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 1998-01-20
- Storage condition of test material: room temperature in a closed vessel

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: 40 - 44 days
- Weight at study initiation: mean body weight: male: 195.5 g ± 9.3 g, female: 157.4 g ± 8.3 g
- Fasting period before study: 16 hours before application and 3 hours after
- Housing: in Makrolon Type 3 cages, 1 animal per cage
- Diet: Altromin Laboratory Standard diet for rats and mice, ALTROMIN 1326, ad libitum
- Water: Community Tap water in Makrolon water bottles, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 25 °C
- Humidity (%): 50 -70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.22 mL/100g body weight
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continously on the day of observation and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortalities were observed
Mortality:
The control and also the treated animals showed no mortality in the course of investigation.
Clinical signs:
other: The control and also the treated animals showed no clinical signs in the course of investigation.
Gross pathology:
There were no substance dependent macroscopic pathological findings in the control and the treated animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified