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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Limited data on materials and method, test substance purity not specified.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Report date:
1983
Reference Type:
secondary source
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
yes
Remarks:
limited data on materials and method, test substance purity not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, USA
- Weight at study initiation: 350.0 g (males), 174.0 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: individual, in wire mesh bottom cages
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
Animals were housed in environmentally controlled rooms.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 8.20 mL (males), 3.96 mL (females)
Doses:
20 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: animals were observed for clinical signs 'frequently' on the day of administration and daily thereafter; body weight was recorded on Day 1 (prior to administration) and Day 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the 15-day observation period.
Clinical signs:
other: 5/5 males and 5/5 females had diarrhoea 1 and 4 h after administration. On Day 2, 2/5 females had apparent urinary incontinence, one of these females also showed decreased activity. 1/5 females had soft stool on Day 2. No clinical signs were observed fro
Gross pathology:
No substance-related findings were observed at the necropsy and histopathological examination.

Any other information on results incl. tables

Table 1. Acute oral toxicity

Dose

[g/kg bw]

Mortality

Clinical signs

 

N*

N*

Males

20

0/5

5/5

Females

20

0/5

5/5

*N= Number of animals/ number of animals used

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified