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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April to June 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test performed according to OECD/EU testing guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Bottom product of propylene oxide and styrene production
IUPAC Name:
Bottom product of propylene oxide and styrene production
Details on test material:
- Name of test material (as cited in study report): KORE grade V
- Substance type: UVCB
- Physical state: Brown viscous liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: from the copany Charles River Deutschland GmbH, D-97633, Sulzfeld
- Age at study initiation: data not available
- Weight at study initiation: between 153g and 163g
- Fasting period before study: yes
- Housing: the rats were kept in transparent macrolone cages (type 3-180, floor area 810 cm2) with 3 in each cage. the cages were cleaned and the bedding changed at least twice a week.
- Diet: free access to a pelleted diet "Altromin 1324"
- Water: free access to bottles of drink water of domestic quality, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: at least 30% and preferably not exceed 70%
- Air changes: 10 times/hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 02-NOV-2009 to 24-NOV-2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: data not available

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: data not available
Doses:
300 mg/kg bw
2000 mg/kg bw
No. of animals per sex per dose:
4 x 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> each rat was observed 30 minutes, 2 hrs, 4hrs and 6hrs after the administration and therafter daily for a period of 14 consecutive days
> the body weight was determined on days 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed at this dose
Mortality:
All six animas survived the treatment with the test item.
Clinical signs:
In group 1, a hunched posture and piloerection were observed in animals No. 1, No. 2 and No. 3 on the day of application after 30 minutes. After 2hrs, 4hrs and 6hrs the three rats showed piloerection. Piloerection was also observed in animal No. 1 on day 1, whereas animals No. 2 and No. 3 showed normal behaviour. From day 2 to the end of the observation period, all three animals were free of any abnormalities.

In group 2, a hunched posture and piloerection were observed in animals No. 4, No. 5 and No. 6 on the day of application after 30 minutes and 2hrs. After 4hrs all three animals still showed piloerection as well as after 6hrs animals No. 4 and No. 6 only. Normal behaviour was observed in animal No. 5 after 6 hrs. From day 1 to the end of the observation period all three animals were free of any abnormalities.
Body weight:
The body weight increased in each animal indicating a physiological development.
Gross pathology:
in the autopsy, no pathological sign was detected

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
oral LD50 (rat, females) > 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study (OECD 423, GLP), groups of fasted, Wistar rats (4 x 3 females) were given a single oral dose of KORE GRADE V - Bottom product of propylene oxide and styrene production (Batch: 21/10/2010) in olive oil. Whereat two groups at the dose of 300 mg/kg bw and two other groups at 2000 mg/kg bw. All groups were observed for 14 days.

 

Oral LD50 (females) > 2000 mg/kg bw

 

No mortality and no effect on body weight were observed.

There were no pathological signs detected in the necropsy, with exception of animal No. 9. The spleen of this rat was slightly swollen.

Signs of toxicosis ranging between slight to severe were observed in the animals.

 

The study is considered as valid. According to this result, KORE GRADE V - Bottom product of propylene oxide and styrene production is not classified according to EU criteria (directive 67/548/EEC and CLP).