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Diss Factsheets

Administrative data

Description of key information

 Evaluation of Acute Oral (Gavage) Toxicity with ACN in Rats - 12/12/2005 _  KBL/2005/1516 Rpo

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08-12/2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
3 g test item filled up to 15 ml using a 0,5% (m/v) solution of Tylose MH 1000 in deionised water.
volume of aministation: 1 ml/100g ody weight
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
6 female animals
Control animals:
no
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Mortality:
None of the animals died durng the course of investigation.
Clinical signs:
A slightly staggering gait in three animals and a slight apathy in one animal were observed on the day of administration.
A slight diarrhoea in one animal was obseved on the day after the administration.
All animals showed a slightly yellow discoloured urine up to the third day after the administration.
Body weight:
The body weight gain of the animals was not affected by the administration of the test item.
Gross pathology:
no pathological findings were observed.

Clinical observations, individual data

 hours or day p.a  animal 1   animal 2   animal 3   animal 4   animal 5   animal 6
 2h  0  0  0  0  0
 3h  0  0  U  U  U
 41/2h  0  0  -  -  -
 6 h  AG  U  GU  U  U  U
  71/2h  AGU  U  GU  -  -  -
  1d  U  U*D  U  U  U  U
  2d  U  U  0  U  U  U
  3d  U  U  U  U  U  U
  4d  0
  5d  0 0  0
  6d  0  0  0  0  0  0
  7d  0  0  0  0  0  0
  8d  0  0  0  0  0
  9d  0  0  0  0  0  0
  10d  0  0  0  0  0  0
  11d  0  0  0  0  0  0
  12d  0  0  0  0  0
  13d  0  0  0  0  0  0
  14d  0  0  0  0  0  0

legend:

0 = no signal observed

A = slight apathy

G = slightly saggering gait

U = slightly yellow discoloured urine

U* = red orange discoloured urine

D = slight diarrhoea

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The product is neither a toxic nor a harmful substance according to this acute oral toxicity study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification